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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 105 - 105
1 Dec 2020
Marchiori G Berni M Veronesi F Cassiolas G Muttini A Barboni B Martini L Fini M Lopomo NF Marcacci M Kon E
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No therapeutic strategy, administered in the early stage of osteoarthritis (OA), is fully able to block the degenerative and inflammatory progress of the pathology, whose only solution remains surgery. Aiming to identify minimally invasive therapies able to act on both degenerative and inflammatory processes, infiltrative treatments based on mesenchymal stem cells represent a promising solution due to their proliferative, immunomodulatory, anti-inflammatory, and paracrine ability. Accordingly, the aim of the present study was to investigate the performance of different cell therapies (stem cells from adipose tissue, ADSCs, stromal vascular fraction, SVF, and culture expanded, AECs vs negative control NaCl) in the treatment of OA. An in vivo model of early OA was developed in sheep knee (research protocol N.62/2018-PR date 29/01/2018 approved by the local Ethical Committee). Three and six months after the treatments injections, gross evaluation of articular surfaces (damage score, DS), histological (cartilage thickness, Th; fibrillation index, FI; collagen II content, C2) and mechanical assessment (elastic modulus, E; stress-relaxation time, τ) of cartilage were carried out. Due to the importance of the relationship between structure/composition (histology) and function (mechanics), this study investigated which of the revealed parameters were involved in such relation and how they were influenced by the level of degeneration and by the specific cell treatment, thus to better understand cell-tissue interaction.

A statistically significant multi-variable linear regression model was found between τ and Th, FI, C2 (R2 0.7, p-value 8.39E-5). The relation was particularly strong between τ and C2 (p-value 7E-4), with a positive coefficient of 0.92. This is in agreement with literature, where a higher cartilage viscosity was related to a major content of collagen. By dividing the samples in two groups depending on cartilage damage, the more degenerated group (DS > 5) showed statistically significant lower C2 (p-value 0.0124) and τ (p-value 0.05), confirming that collagen content and viscosity decrease with OA grade increasing. Averaging the entire group of samples, the OA degeneration progressed between 3 and 6 months after, and despite, the treatment. But focusing on specific treatments, SVF and AECs differed from the general trend, inducing a higher amount of collagen at 6 months respect to 3 months. Moreover, articular cartilage treated by AECs and, overall, SVF showed a higher content of collagen and a major viscosity respect to the other treatments.

We conclude that an injection of mesenchymal stem cells from stromal vascular fraction in early OA articulations could hinder the degenerative process, preserving or even restoring collagen content and viscosity of the articular cartilage.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 89 - 89
1 Jan 2017
Zaffagnini S Signorelli C Raggi F Grassi A Roberti Di Sarsina T Bonanzinga T Lopomo N Marcacci M
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The Pivot-shift phenomenon (PS) is known to be one of the essential signs of functional insufficiency of the anterior cruciate ligament (ACL). To evaluate the dynamic knee laxity is very important to accurately diagnose ACL injury, to assess surgical reconstructive techniques, and to evaluate treatment approaches. However, the pivot-shift test remains a subjective clinical examination difficult to quantify. The aim of the present study is to validate the use of an innovative non-invasive device based on the use of an inertial sensor to quantify PS test. The validation was based on comparison with data acquired by a surgical navigation system.

The surgeon intraoperatively performed the PS tests on 15 patients just before fixing the graft required for the ACL reconstruction. A single accelerometer and a navigation system simultaneously acquired the joint kinematics. An additional optical tracker set to the accelerometer has allowed to quantify the movement of the sensor. The tibial anteroposterior acceleration obtained with the navigation system was compared with the acceleration acquired by the accelerometer. It is therefore estimated the presence of any artifacts due to the soft tissue as the test-retest repositioning error in the positioning of the sensor. It was also examined, the repeatability of the acceleration parameters necessary for the diagnosis of a possible ACL lesion and the waveform of the output signal obtained during the test. Finally it has been evaluated the correlation between the two acceleration measurements obtained by the two sensors.

The RMS (root mean square) of the error of test-retest positioning has reported a good value of 5.5 ± 2.9 mm. While the amounts related to the presence of soft tissue artifacts was equal to 4.9 ± 2.6 mm. It was also given a good intra-tester repeatability (Cronbach's alpha = 0.86). The inter-patient similarity analysis showed a high correlation in the acceleration waveform of 0.88 ± 0.14. Finally the measurements obtained between the two systems showed a good correlation (rs = 0.72, p<0.05).

This study showed good reliability of the proposed scheme and a good correlation with the results of the navigation system. The proposed device is therefore to be considered a valid method for evaluating dynamic joint laxity.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 79 - 79
1 Jan 2017
Zaffagnini S Signorelli C Bontempi M Bragonzoni L Raggi F Marchiori G Lopomo N Marcacci M
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Anterior cruciate ligament (acl) reconstruction is one of the most commonly performed procedures in orthopedics for acl injury. While literature suggest short-term good-to-excellent functional results, a significant number of long-term studies report unexplained early oa development, regardless type of reconstruction. The present study reports the feasibility analysis and development of a clinical protocol, integrating different methodologies, able to determine which acl reconstruction technique could have the best chance to prevent oa. It gives also clinicians an effective tool to minimize the incidence of early oa.

A prospective clinical trial was defined to evaluate clinical outcome, biochemical changes in cartilage, biomechanical parameters and possible development of oa. The most common reconstruction techniques were selected for this study, including hamstring single-bundle, single-bundle with extraarticular tenodesis and anatomical double-bundle. Power analysis was performed in terms of changes at cartilage level measurable by mri with t2 mapping. A sample size of 42 patients with isolated traumatic acl injury were therefore identified, considering a possible 10% to follow-up. Subjects presenting skeletal immaturity, degenerative tear of acl, other potential risk factors of oa and previous knee surgery were excluded. Included patients were randomized and underwent one of the 3 specified reconstruction techniques. The patients were evaluated pre-operatively, intra-operatively and post-operatively at 4 and 18 months of follow-up. Clinical evaluation were performed at each time using subjective scores (koos) and generic health status (sf-12). The activity level were documented (marx) as well as objective function (ikdc).

Preliminary results allow to verify kinematic patterns during active tasks, including level walking, stair descending and squatting using dynamic roentgen sterephotogrammetric analysis (rsa) methodology before and after the injured ligament reconstruction. Intra-operative kinematics was also available by using a dedicated navigation system, thus to verify knee laxity at the time of surgery. Additionally, non-invasive assessment was possible both before the reconstruction and during the whole follow-up period by using inertial sensors. Integrating 3d models with kinematic data, estimation of contact areas of stress patterns on cartilage was also possible.

The presented integrate protocol allowed to acquired different types of information concerning clinical assessment, biochemical changes in cartilage and biomechanical parameters to identify which acl reconstruction could present the most chondroprotective behavior. Preliminary data showed all the potential of the proposed workflow. The study is on-going and final results will be shortly provided.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 102 - 102
1 Jan 2017
Russo A Bianchi M Sartori M Parrilli A Panseri S Ortolani A Boi M Salter D Maltarello M Giavaresi G Fini M Dediu V Tampieri A Marcacci M
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A critical bone defect may be more frequently the consequence of a trauma, especially when a fracture occurs with wide exposure, but also of an infection, of a neoplasm or congenital deformities. This defect needs to be treated in order to restore the limb function. The treatments most commonly performed are represented by implantation of autologous or homologous bone, vascularized fibular grafting with autologous or use of external fixators; all these treatments are characterized by several limitations.

Nowadays bone tissue engineering is looking forward new solutions: magnetic scaffolds have recently attracted significant attention. These scaffolds can improve bone formation by acting as a “fixed station” able to accumulate/release targeted growth factors and other soluble mediators in the defect area under the influence of an external magnetic field. Further, magnetic scaffolds are envisaged to improve implant fixation when compared to not-magnetic implants.

We performed a series of experimental studies to evaluate bone regeneration in rabbit femoral condyle defect by implanting hydroxyapatite (HA), polycaprolactone (PCL) and collagen/HA hybrid scaffolds in combination with permanent magnets.

Our results showed that ostetoconductive properties of the scaffolds are well preserved despite the presence of a magnetic component. Interestingly, we noticed that, using bio-resorbable collagen/HA magnetic scaffolds, under the effect of the static magnetic field generated by the permanent magnet, the reorganization of the magnetized collagen fibers produces a highly-peculiar bone pattern, with highly-interconnected trabeculae orthogonally oriented with respect to the magnetic field lines. Only partial healing of the defect was seen within the not magnetic control groups.

Magnetic scaffolds developed open new perspectives on the possibility to exploiting magnetic forces to improve implant fixation, stimulate bone formation and control the bone morphology of regenerated bone by synergically combining static magnetic fields and magnetized biomaterials. Moreover magnetic forces can be exploited to guide targeted drug delivery of growth factors functionalized with nanoparticles.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 18 - 18
1 May 2016
Bruni D Marcacci M Bignozzi S Zaffagnini S Iacono F
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Introduction

Proper alignment (tibial alignment, femoral alignment, and overall anatomic alignment) of the prosthesis during total knee replacement is critical in maximizing implant survival[7] and to reduce polyethylene wear[1]. Poor overall anatomic alignment of a total knee replacement was associated with a 6.9 times greater risk of failure due to tibial collapse, that varus tibial alignment is associated with a 3.2 times greater risk[2] and valgus femoral alignment is associated with a 5.1 times greater risk of failure[7]. To reduce this variability intramedullary (IM) instruments have been widely used, with increased risk of the fat emboli rate to the lungs and brain during TKA[6] and possible increase of blood loss[4, 5]. Or, alternatively, navigation has been used to achieve proper alignment and to reduce morbidity[3]. Recently, for distal femoral resection, inertial sensors have been coupled to extramedullary (EM) instruments to improve TKA surgery in terms of femoral implant alignment, with respect to femoral mechanical axis, and reduced morbidity by avoidance of IM canal violation. The purpose if this study is to compare blood loss and alignment of distal femoral cut in three cohorts of patients: 1 Operated with inertial based cutting guide; 2 Operated with navigation instruments; 3 operated with conventional IM instruments.

Material and methods

From September to November 2014 30 consecutive patients, eligible for TKA, were randomly divided into three cohorts with 10 patients each:x 1 “EM Perseus”, patient operated with EM inertial based instruments (Perseus, Orthokey Italia srl, Florence, Italy); 2 “EM Nav”, operated with standard navigated technique, where bone resections were planned and verified by mean of navigation system (BLUIGS, Orthokey Italia srl, Florence, Italy); 3 “IM Conv”, operated with standard IM instrumentation. All patients were operated by the same surgical technique, implanted TKA were mobile bearing PS models, Gemini (Waldemar Link, Hamburg, Germany) and Attune (Depuy, Warsaw, Indiana). Anteroposterior, lateral, and full-limb weightbearing views preoperatively and postoperatively at discharge were obtained, taking care of neutral limb rotational positioning in all patients enrolled in the study. Angles between femoral mechanical axis and implant orientation on frontal and lateral planes were measured with a CAD software (Rhinoceros 3, McNeel Europe, Rome, Italy) by two independent persons, average value was used for statistical analysis. Haemoglobin values were recorded at three time intervals: the day before surgery, at 24h follow-up and at patients discharge.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 11 - 11
1 May 2016
Russo A Lopomo N Bianchi M Boi M Ortolani A Gambardella A Marchiori G Maltarello M Visani A Marcacci M
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Introduction

Protective hard coatings are appealing for several technological applications and even for orthopaedic implants and prosthetic devices. For what concerns the application to prosthetic components, coating of the surface of the metallic part with low-friction and low-wear materials has been proposed [1, 2]; at the same time, concerning use of ceramic materials in joint arthroplasty, zirconia-toughned-alumina (ZTA) ceramic material has shown high strength, fracture toughness, elasticity, hardness, and wear resistance [3, 4]. The purpose of this study was to directly deposit ZTA coatings by using a novel sputter-based electron deposition technique, namely Pulsed Plasma Deposition (PPD) [5]. Preliminary characterization of realized coatings from the point of view of morphology, wettability, adhesion and friction coefficients was performed.

Materials and methods

PPD technique was used to deposit ZTA coatings; this technique is able to maintain the stoichiometry of the starting target. In this study we started from a cylindrical ZTA target (30 mm diameter × 5 mm thickness, 75% alumina / 25% zirconia) and followed the procedure described by Bianchi et al [5]. Characterization of morphology, micro-structure and chemistry of deposited coatings was performed by Scanning Electron Microscopy (SEM) equipped with Energy Dispersive X-ray Spectroscopy (EDS) and Atomic Force Microscope (AFM). Coating-substrate interface quality were investigated by micro-scratch tests. Measurement of the contact angle between a drop of 1 ml of ultrapure water and the surface of the sample was performed to estimate the degree of wetting. A ZTA-coated stainless steel ball (AISI 420, 3 mm radius) was coupled against medical grade UHMWPE to evaluate the friction of the proposed coupling in preliminary ball-on-disk tribological tests.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 56 - 56
1 May 2016
Bruni D Bragonzoni L Bontempi M Akkawi I Raspugli G Iacono F Marcacci M
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The main purpose of the present study was to determine long-term implant fixation of 15 unicompartmental knee arthroplasty (UKAs) with an all-poly tibial component using Roentgen stereophotogrammetric analysis (RSA) at a mean 10-year follow-up. The secondary purpose was to investigate whether the progressive loss of implant's fixation correlates with a reduction in Knee society score (KSS). Fifteen non-consecutive patients with primary knee osteoarthritis received a UKA with an all-poly tibial component were assessed using KSS scores pre-operatively and post-operatively and RSA on day 2 after surgery, then at 3, 6, and 12 months and yearly thereafter. The mean last follow-up was 10 years. An increase in maximum total point motion (MTPM) values from 6 months to 1 year post-operatively was found respect to post-operative reference. Implants’ displacement values were always 2 mm during the first 6 months, and then, two different trends were noticed in revised and non-revised implants. MTPM increase between 1 and 2 years of follow-up in non-revised UKAs was always 0.2 mm, whereas it was [0.2 mm in revised UKAs. A linear and negative correlation with statistical significance was found between MTPM and both clinical and functional KSS scores (p 0.001). Also in a long-term follow-up evaluation, RSA is an effective tool to predict functional results after an all-poly UKA providing also a relevant predictive value at 1 year follow-up, and this can be very useful for both patients and surgeons.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 57 - 57
1 May 2016
Bruni D Iacono F Bignozzi S Marcacci M
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The main purpose of the present study is to prospectively investigate whether preoperative functional flexion axis in patients with osteoarthritisand varus-alignment changes after total knee arthroplasty and whether a correlation exists both between preoperative functional flexion axis and native limb deformity. A navigated total knee arthroplasty was performed in 108 patients using a specific software to acquire passive joint kinematics before and after implant positioning. The knee was cycled through three passive range of motions, from 0 to 120. Functional flexion axis was computed using the mean helical axis algorithm. The angle between the functional flexion axis and the surgical transepicondylar axis was determined on frontal (aF) and axial (aA) plane. The pre- and postoperative hip-kneeankle angle, related to femur mechanical axis, was determined. Postoperative functional flexion axis was different from preoperative only on frontal plane, while no differences were found on axial plane. No correlation was found between preoperative aA and native limb deformity, while a poor correlation was found in frontal plane, between aF and preoperative hip-knee-ankle angle. Total knee arthroplasty affects functional flexion axis only on frontal plane while has no effect on axial plane. Preoperative functional flexion axis is in a more varus position respect to the transepicondylar axis both in pre- and postoperative conditions. Moreover, the position of the functional axis on frontal plane in preoperative conditions is dependent on native limb alignment, while on axial plane is not dependent on the amount of preoperative varus deformity.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 10 - 10
1 May 2016
Russo A Bianchi M Lopomo N Boi M Ortolani A Marchiori G Gambardella A Maltarello M Visani A Marcacci M
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Introduction

Total joint arthroplasty is frequently necessary when a traumatic or degenerative disease leads to develop osteoarthritis (OA). Nowadays, the main reason for long term prosthesis failure is due to osteolysys and aseptic loosening of the implant itself, that are related to UHMWPE wear debris [1–3]. Different solutions to overcome this issue have been proposed, including different couplings like metal-on-metal and ceramic-on-ceramic. Our hypothesis was that a hard ceramic thin film realized on the plastic component (i.e. UHMWPE) could improve the friction and wear performance in a prosthetic coupling. The purpose of the presented study was therefore to characterize from the point of view of structure and mechanical performance of this ceramic-coated plastic component. The thin films were specifically realized by means of the novel Pulsed Plasma Deposition (PPD) technique [4].

Materials and methods

PPD technique was used to deposit Yttria-stabilized zirconia (YSZ at 3%) films on medical-grade UHMWPE substrates [4]. The morphology and micro-structure were characterized by Scanning Electron Microscopy (SEM) equipped with Energy Dispersive X-ray Spectroscopy (EDS), X-ray diffraction (XRD) and X-ray Photoelectron Spectroscopy (XPS). By means of nanoindentation and scratch tests mechanical properties were investigated. Ball-on-disk tribological tests were carried out in air, deionized water and physiological solution against alumina balls (6 mm diameter, grade 200) used as counterpart; friction evaluation of the proposed approach and the corresponding worn track were analyzed by SEM-EDS.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 56 - 56
1 Jan 2016
Bruni D Marko T Gagliardi M Bignozzi S Zaffagnini S Akkawi I Colle F Marcacci M
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Introduction

The purpose of this study was to examine whether three types of mobile-bearing PCL sacrificing TKA could restore the native knee translation and rotation. The primary hypothesis was that there are differences in knee kinematics and laxity between three different cruciate-substituting TKA designs: 1 with post-cam mechanism, 2 post-cam mechanism based on an inter-condylar ‘third condyle’ concept, 3 anterior stabilized with deep-dished highly congruent tibial insert; specifically, showing different femoral external rotation with flexion, different femoral translation with flexion and different laxity under stress test. The secondary hypothesis was that there is different clinical outcome between the three TKA designs at 2 years follow-up.

Methods

We recruited 3 cohorts consisting of 30 patients each divided according 3 different TKA designs. All patients were operated with navigated procedure. During surgery preoperative and postoperative kinematics were recorded, in terms of femoral antero-posterior translation and tibial rotation during knee flexion, as also preoperative and postoperative at 2 years follow-up clinical scores have been acquired.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 57 - 57
1 Jan 2016
Bruni D Gagliardi M Grassi A Raspugli G Akkawi I Marko T Marcacci M
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BACKGROUND

Some papers recently reported conflicting results on implant survivorship in all-poly tibial UKRs. Furthermore, the influence of BMI on this specific implant survivorship remains unclear, since existing reports are often based on small series of non-consecutive patients with different follow up durations, enabling to generate meaningful conclusions.

PURPOSE

To determine the 10-years survival rate of an all-poly tibial UKR in a large series of consecutive patients and to investigate whether a correlation exists between a higher BMI and an increased risk of revision for any reason.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 58 - 58
1 Jan 2016
Bruni D Bragonzoni L Gagliardi M Bontempi M Marko T Patella S Marcacci M
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Background

Roentgen Stereophotogrammetric Analysis (RSA) represents nowadays an excellent solution for high-accuracy fixation measurement of UKAs. To date, to the best of our knowledge, no previous study has investigated long-term micromotions of a UKA using RSA. For this reason, the main purpose of the present study is to determine long-term implant fixation of 15 UKAs with all-poly tibial component using RSA at a mean 10-years follow-up. The secondary purpose was to investigate whether the progressive loss of implant's fixation correlates with a reduction of KSS scores.

Methods

Fifteen non-consecutive patients with primary knee osteoarthritis received a UKA with an all-poly tibial component between January 1995 and April 2003 in the Authors' institution. Pre and post-operative KSS scores were recorded. RSA evaluation was performed on day 2 after surgery, than at 3, 6, and 12 months and yearly thereafter. The patients were evaluated with a mean follow-up of 10 years.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 92 - 92
1 Jan 2016
Colle F Lopomo N Bruni D Gagliardi M Marko T Francesco Iacono Zaffagnini S Marcacci M
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Introduction

Providing proper rotational alignment of femoral component in total knee arthroplasty is mandatory to achieve correct kinematics, good ligament balance and proper patellar tracking. Recently functional references, like the function flexion axis (FFA), have been introduced to achieve this goal. Several studies reported the benefits of using the FFA but highlighted that further analyses are required to better verify the FFA applicability to the general clinical practice. Starting from the hypothesis that the FFA can thoroughly describe knee kinematics but that the joint kinematics itself can be different from flexion to extension movements, the purpose of this study was to analyse which factors could affect the FFA estimation by separately focusing on flexion and extension movements.

Methods

Anatomical acquisitions and passive joint kinematics were acquired on 79 patients undergoing total knee arthroplasty using a commercial navigation system. Knee functional axis was estimated, from three flexion and extension movements separately acquired included in a range between 0° and 120°. For flexion and extension, in both pre- and post-implant conditions, internal-external (IE) rotations was analysed to track any changes in kinematic pattern, whereas differences in FFA estimation were identified by analysing the angle between the FFA itself and the transepicondylar axis (TEA) in axial and frontal plane.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 155 - 155
1 Jan 2016
Lopomo N Bianchi M Boi M Maltarello MC Liscio F Visani A Ortolani A Marcacci M Russo A
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Introduction

Protective hard coatings are appealing for several technological applications like solar cells, organic electronics, fuel cells, cutting tools and even for orthopaedic implants and prosthetic devices. At present for what concerns the application to prosthetic components, the coating of the surface of the metallic part with low-friction and low-wear materials has been proposed [1]. Concerning the use of ceramic materials in joint arthroplasty, zirconia-toughned-alumina (ZTA) reported high strength, fracture toughness, elasticity, hardness, and wear resistance [2]. The main goal of this study was to directly deposit ZTA coating by using a novel sputter-based electron deposition technique, namely Pulsed Plasma Deposition (PPD) [3]. The realized coatings have been preliminary characterized from the point of view of morphology, wettability, adhesion and friction coefficients.

Materials and methods

ZTA coatings were deposited by PPD technique, which is able to maintain the stoichiometry of the starting target. In this case we started from a cylindrical ZTA target (30 mm diameter × 5 mm thickness, 75% alumina / 25% zirconia). The morphology, micro-structure and chemistry of deposited coatings were characterized by Scanning Electron Microscopy (SEM) equipped with Energy Dispersive X-ray Spectrosopy (EDS) and Atomic Force Microcscope (AFM). Coating-substrate interface quality were investigated by microscratch tests. The degree of wetting was estimated by measuring the contact angle between a drop of 1 ml of ultrapure water and the surface of the sample. Preliminary ball-on-disk tribological tests were carried out in air and deionized water coupling ZTA-coated stainless steel ball (AISI 420, 3 mm radius, grade 200) against medical grade UHMWPE to evaluate the friction of the proposed coupling.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 55 - 55
1 Jan 2016
Bruni D Gagliardi M Marko T Raspugli G Akkawi I Marcacci M
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PURPOSE

Lateral osteoarthritis of the valgus knee is a challenging problem, especially for young and active patients, where prosthetic replacement is not indicated. The purpose of the present study is to evaluate clinically and radiographically 91 patients with valgus knee treated with distal femoral varus osteotomy in mid and long term follow-up.

METHODS

A clinical retrospective evaluation based on IKDC, OXFORD and WOMAC scores of 91 patients at 4 to 10 years of follow-up was performed. Subjective evaluation was based on a VAS for pain self-assessment. Radiographic evaluation was performed by an independent observer of all 91 patients at 2 to 6 years of follow-up. A survival analysis was performed assuming revision for any reason as primary endpoint.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 94 - 94
1 Jan 2016
Colle F Lopomo N Bruni D Francesco Iacono Zaffagnini S Marcacci M
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Introduction

Several methods, based on both functional and anatomical references, have been studied to reach the goal of a proper knee kinematics in total knee arthroplasty (TKA). However, at present, there is still a large debate about which is the most precise and accurate method to achieve the correct rotational implant positioning. One of the main methods already used in TKA to describe the tibiofemoral flexion-extension movement, based on a kinematic technique, thus not influenced by the typical variability related to the identification of anatomical references, is called “functional flexion axis” (FFA) method. The purpose of this study was to determine the repeatability in estimating knee functional flexion axis, thus evaluating the robustness of the method for navigated total knee arthroplasty.

Methods

Passive kinematic and anatomical acquisitions were performed with a commercial navigation system on 87 patients undergoing TKA with primary osteoarthritis. Knee FFA was estimated, before and after implant positioning, from three flexion-extension movements between 0° and 120° (Figure 1). The angle between Functional Flexion Axis and an arbitrary clinical reference, the transepicondylar axis (TEA), was analysed in frontal and axial view (Figure 2). Repeatability Coefficient and Intraclass Correlation Coefficient (ICC) were estimated to analyse the reliability and the agreement in identifying the axis.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 1 - 1
1 Jan 2016
Bianchi M Lopomo N Boi M Maltarello MC Liscio F Milita S Visani A Ortolani A Marcacci M Russo A
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Wear of the ultra-high molecular weight polyethylene (UHMWPE) insert is one of the major issue related to orthopaedic implants. In this study, the tribo-mechanical properties of zirconia-coated UHMWPE deposited by means of Pulsed Plasma Deposition (PPD) technique were analyzed. Specifically, strength to local plastic deformation, indentation work portioning and creep behavior were evaluated through nanoindentation and micro-scratch tests, whereas preliminary wear data were obtained by tribology tests. A strong reduction of plastic deformation and a drop of the creep phenomenon for the zirconia-coated UHMWPE were evidenced, whereas - in spite of similar wear data - different wear mechanism was also detected. This study supported the use of hard ceramic thin films to enhance the mechanical performance of the plastic inserts used in orthopaedics.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 93 - 93
1 Jan 2016
Colle F Lopomo N Bruni D Capozzi M Zaffagnini S Marcacci M
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Introduction

The use of a surgical navigation system has been demonstrated to allow to intraoperatively analyze knee kinematics during total knee arthroplasty (TKA), thus providing the surgeon with a quantitative and reproducible estimation of the knee functional behaviour. Recently severak authors used the computer assisted surgery (CAS) for kinematic evaluations during TKA, in particular to evaluate the achievement of a correct joint biomechanics after the prosthesis implantation. The major concern related to CAS is that the movements are usually passively performed, thence without a real active task performed by the subject. Starting from the hypothesis that the passive kinematics may properly describe the biomechanic behaviour of the knee, the main goal of this work was to intra-operatively compare the active kinematics of the limb, analysing a flexion movement actively performed by the patient, and the passive kinematics, manually performed by the surgeon.

Methods

The anatomical and kinematic acquisitions were performed on 31 patients TKA using a commercial navigation system (BLU-IGS, Orthokey, USA). All the surgeries were performed under local anesthesia, which specifically allowed to acquire the passive and active kinematics including three flexion movements. Both in pre- and post-implant conditions, internal-external (IE) rotations and anterior-posterior (AP) translations were estimated to track any changes in the kinematic pattern.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 3 - 3
1 Jul 2014
Bruni D Iacono F Bignozzi S Colle F Marcacci M
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Background

The optimal reference for rotational positioning of femoral component in total knee replacement (TKR) is debated. Navigation has been suggested for intra-op acquisition of patient's specific kinematics and functional flexion axis (FFA).

Questions/Purposes

To prospectively investigate whether pre-operative FFA in patients with osteoarthritis (OA) and varus alignment changes after TKR and whether a correlation exists between post-op FFA and pre-op alignment.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 87 - 87
1 Jul 2014
Bianchi M Edreira EU Wolke J Birgani ZT Habibovi P Tampieri A Jansen J Marcacci M Leeuwenburg S van den Beucken J
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Summary Statement

Repetitive concavities threaded on the surface of bone implants have been already demonstrated to be effective on ectopic bone formation in vivo. The aim of this study was to investigate the effect of concavity on the mineralization process in vitro.

Introduction

The role of implant surface geometry in bone formation has been extensively investigated. Ripamonti and co. investigated the possibility to induce bone formation by threading concavities on the surface of calcium phosphate implants, without the need for exogenous osteogenic soluble factors. The underlying hypothesis was that this geometry, by resembling the hemi-osteon trench observable during osteoclastogenesis, was able to activate the ripple-like cascade of bone tissue induction and morphogenesis. Despite several studies indicating a positive effect of concavities on bone induction, so far no attempts have rationalised this phenomenon by means of in vitro tests. Consequently, this study aimed to evaluate the effect of surface concavities on the mineralization of hydroxyapatite (HA) and beta-tricalciumphosphate (b-TCP) ceramics in vitro. Our hypothesis was that concavities could effectively guide the mineralization process in vitro.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 514 - 514
1 Dec 2013
Russo A Bianchi M Lopomo N Maltarello MC Ortolani A Marcacci M
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Introduction

When osteoarthritis occurs, joint replacement is the most frequent treatment. Currently, the mean survival rate for total joint arthroplasty is ∼90% after 10 years: the main reason for long-term implant failure, that generally required a revision surgery, are osteolysis and aseptic loosening of the implant, which are strongly correlated with wear debris formation from the UHMWPE insert [Ingham, 2005], as a consequence of the cyclic loading against the metallic or ceramic counterface [Dumbleton, 2002]. Wear debris bring to chronic inflammation of periprosthetic tissues causing an increase of bone reabsorption that finally provoke aseptic loosening, so implant failure[Holt, 2007]. Different solutions were proposed to reduce wear debris production but agreement has not been achieved yet. Our challenging approach prefigures the direct coating of the plastic component with a hard and well-adherent ceramic film, in order to drastically reduce wear debris formation from the plastic substrate while preserving its well-established bulk mechanical properties, especially under high local loads [Bianchi, 2013].

Methods

3%yttria-stabilized zirconia films were deposited by PPD technique. PPD is a new vapour deposition technique based on the ablation of a target material as a consequence of the impact of a high-energy electron beam. The plasma plume of ablated material is directed toward and deposited onto the substrate. Films were characterized by SEM-EDX, X-ray diffraction, nanoindentation, adhesion and tribological tests. Moreover, capability of ZrO2–UHMWPE system of carrying local loads – i.e. an estimation of the resistance to a third-body abrasion – was investigated.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 165 - 165
1 Dec 2013
Russo A Panseri S Shelyakova T Sandri M Ortolani A Meikle S Lacey J Tampieri A Dediu V Santin M Marcacci M
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Introduction

Diaphyseal bone defect represents a significant problem for orthopaedic surgeons and patients. Bone is a complex tissue whose structure and function depend strictly on ultrastructural organization of its components: cells, organic (extracellular matrix, ECM) and inorganic components. The purpose of this study was to evaluate bone regeneration in a critical diaphyseal defect treated by implantation of a magnetic scaffold fixed by hybrid system (magnetic and mechanical), supplied through nanoparticle-magnetic (MNP) functionalized with Vascular Endothelial-Growth-Factor-(VEGF) and magnetic-guiding.

Methods

A critical long bone defect was created in 8 sheep metatarsus diaphysis: it was 20.0 mm in length; the medullary canal was reamed till 8.00 mm of inner diameter. Then a 8.00 mm diameter magnetic rod was fitted into proximal medullary canal (10 mm in length).

After that a scaffold made of Hydroxyapatite (outer diameter 17.00 mm) that incorporates magnetite (HA/Mgn 90/10) was implanted to fill critical long bone defect. A magnetic rod (6.00 mm diameter) was firmly incorporated at proximal side into the scaffold. Both magnets had 10 mm length. To give stability to the complex bone-scaffold-bone a plate was used as a bridge; it was fixed proximally by 2 screws and distally by 3 screws.

Scaffolds biocompatibility was previously assessed in vitro using human osteoblast-like cells. Magnetic forces through scaffold were calculated by finite element software (COMSOL Multiphysics, AC/DC Model).

One week after surgery, magnetic nanoparticles functionalized with VEGF were injected at the mid portion of the scaffold using a cutaneous marker positioned during surgery as reference point in 4 sheep; other sheep were used as control group. After sixteen weeks, sheep were sacrificed to analyze metatarsi. Macroscopical, radiological and microCT examinations were performed.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 245 - 245
1 Dec 2013
Bruni D Iacono F Raspugli G Akkawi I Marcacci M
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Purpose:

Management of unicompartmental knee osteoarthritis (OA) in middle-aged patients is a challenging problem. Recent studies have underlined the efficacy of UKA not just in elderly, but also in middle-aged patients. The primary purpose of the present study was to determine the short to mid-term survivorship of an all-poly tibial UKA in patients under 60 years of age. The secondary purpose was to prospectively evaluate the clinical outcome in this selected group of patients.

METHODS:

Thirty-three consecutive patients under 60 years of age at the time of surgery with isolated medial compartment OA underwent a unilateral medial UKA from 2002 to 2005 and were prospectively followed. A Kaplan-Meyer analysis was performed to determine the 8-years implant survivorship with revision for any reason as endpoint. KSS, WOMAC, Tegner-Lysholm, Tegner and VAS scores were prospectively evaluated at 3 to 6 years follow-up. Weight-bearing radiographs were collected pre-operatively and at 3 to 6 years follow-up to prospectively evaluate femorotibial angle (FTA), tibial plateau angle (TPA) and posterior tibial slope (PTS).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 247 - 247
1 Dec 2013
Bruni D Bragonzoni L Bontempi M Gagliardi M Akkawi I Marcacci M
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Introdution:

Over the last years research has focused on attempts to achieve better fixation in knee prosthesis by improving cementing techniques and prosthetic designs; thus prosthetic fixation is critical while loosening at the bone-cement interface is still an important matter for the orthopaedic surgeon.

Material and Method:

In the present study, we evaluated in vivo displacement of both total and unicompartimental knee prosthesis implanted on 73 patients by collecting data from RSA associated to the conventional X-rays and clinical follow-ups; we were able to reach only 18 patients (2 males and 16 females) for the actual follow up because of death or other diseases occurred on the other patients over the years (mean age at the time of surgery 68, range 27–83).


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 19 - 19
1 Dec 2013
Bruni D Iacono F Colle F Bignozzi S Marcacci M
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BACKGROUND:

The optimal reference for rotational positioning of femoral component in total knee replacement (TKR) is debated. Navigation has been suggested for intra-op acquisition of patient's specific kinematics and functional flexion axis (FFA).

QUESTIONS/PURPOSES:

To prospectively investigate whether pre-operative FFA in patients with osteoarthritis (OA) and varus alignment changes after TKR and whether a correlation exists between post-op FFA and pre-op alignment.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 246 - 246
1 Dec 2013
Bruni D Bragonzoni L Gagliardi M Bontempi M Marcacci M
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The Rizzoli Orthopaedic Institute has been involved in RSA since 1998. During last 25 years, several investigations have been carried on to evaluate both implant fixation and poliethylene deformation in unicompartmental and total knee replacements. Nevertheless, RSA has also been used to investigate the relative micromotions and the kinematic modifications in cadaveric models of ankles with ligamentous injuries. RSA evaluation has demonstrated that in a particular TKR implant, with mobile half-bearings, the threshold for loosening was 1.3° for rotation about the longitudinal axis and 0.5 mm for medio-lateral translation. Moreover, RSA has revealed cold flow to be concentrated in the posterior region of the medial half-bearing. This has lead to further improvement in polyethilene and implant design. RSA has also demonstrated that in all-poly tibial UKR, poliwear does not impair tibial component fixation and that deformation of the all-poly tibial component is strictly correlated to implant loosening. Moreover, RSA has been used to investigate stress-inducible displacement of the tibial component in all-poly UKRs. It has been demonstrated that rotations around the transverse axis of the knee joint are the most common form of stress-inducible displacement, while stress-induced translations are negligible. Moreover, stress-inducible translational displacement has reached significantly higher values for those patients with unexplained painful UKR, despite no sign of loosening on conventional radiographic and standard supine RSA evaluations.

Further application of RSA has focused on the kinematic evaluation of poliethilene motion pattern modifications throughout a 3 years follow-up period after a mobile-bearing TKR. Patients have been investigated in weight-bearing conditions and results demonstrated that longitudinal rotations and medio-lateral translations tended to increase at last follow-up, while sagittal translations dod not show any significant modification over time.

At present, a new device has been installed at the Istituto Ortopedico Rizzoli. It was specifically designed and made for RSA, static and fluoroscopic. This device can work both in mono- and bi-planar configuration as required by the RSA protocols. Moreover it is able to acquire image stacks in order to study the in-vivo and real time kinematics of a joint. he theoretical biomechanical resolution of a static RSA followup tests is 0.2 mm for translation and 0.3° for rotation. In fluoroscopic configuration the theoretical resolution is 1 mm for translation and 1° for rotations, depending on the used frame rate and on the joint movement speed. A kinematic comparison of different prosthetic designs is currently ongoing, to evaluate different motion patterns under dynamic weight-bearing conditions and to compare them with passive kinematics acquired intra-operatively using a navigation system.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 26 - 26
1 Mar 2013
Bruni D Iacono F Presti ML Raspugli G Sharma B Marcacci M
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INTRODUCTION

The purpose of our work was to evaluate changes in clinical scores, passive knee kinematics and stability after mobile bearing TKA surgery.

MATERIAL AND METHODS

60 patients were treated with a mobile bearing prosthesis (Gemini, Waldemar Link, Hamburg, Germany). PCL was always resected. Inclusion criteria were BMI >30, age range 60–80 yrs. Preoperative KSS, KOOS and SF36 scores were recorded. Surgeries were performed with a navigation system (BLU-IGS, Orthokey Italia, Firenze, Italy) to verify bone cuts, ligament balancing and implant positioning. Kinematic tests were executed to determine: tibial rotation and femoral translation through flexion range. Stability tests were performed using varus-valgus stress in extension and at 30° of flexion and drawer test. Acquisition were perfomed with menisci and cruciate ligaments intact, and repeated after final implant fixation. Clinical scores were recorded at 6 months follow-up.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 140 - 140
1 Mar 2013
Bruni D Iacono F Lo Presti M Raspugli G Sharma B Marcacci M
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INTRODUCTION

The literature suggests a survivorship of unicompartmental knee arthroplasties (UKA) for spontaneous osteonecrosisof the knee range from 93% to 96.7% at 10 to 12 years. However, these data arise from series reporting 23 to 33 patients, jeopardizing meaningful conclusions.

OBJECTIVES

Our purpose is to examine a long term survivorship of UKA's in a larger group of patients with SPONK, along with their subjective, symptomatic and functional outcome; to determine the percentage of failures and the reasons for the same in an attempt to identify relevant indications, contraindications, and technical parameters in treating SPONK with a modern implant design.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 25 - 25
1 Mar 2013
Bruni D Iacono F Presti ML Sharma B Raspugli G Marcacci M
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INTRODUCTION

Conventional surgical exposures are usually inadequate for 2-stage revision knee replacement ofinfected implants. Reduced range of motion, extensor mechanism stiffness, peripatellar contracture and soft tissue scarring make patellar eversion difficult and forced eversion places the integrity of the extensor mechanism at risk. On the contrary, a wide exposure is fundamental to allow complete cement spacer removal, soft tissue balancing, management of bone loss and reimplantation without damaging periarticular soft tissues.

OBJECTIVES

To compare the long-term clinical, functional and radiographic results and the reinfection rate of the quadriceps snip approach and the tibial tubercle osteotomy in 2-stage revision knee replacement performed for septic loosening of the primary implant.


Bone & Joint Research
Vol. 2, Issue 2 | Pages 18 - 25
1 Feb 2013
Kon E Filardo G Di Matteo B Perdisa F Marcacci M

Objectives

Matrix-assisted autologous chondrocyte transplantation (MACT) has been developed and applied in the clinical practice in the last decade to overcome most of the disadvantages of the first generation procedures. The purpose of this systematic review is to document and analyse the available literature on the results of MACT in the treatment of chondral and osteochondral lesions of the knee.

Methods

All studies published in English addressing MACT procedures were identified, including those that fulfilled the following criteria: 1) level I-IV evidence, 2) measures of functional or clinical outcome, 3) outcome related to cartilage lesions of the knee cartilage.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 328 - 328
1 Sep 2012
Zaffagnini S Marcacci M Marcheggiani Muccioli GM Bulgheroni P Berbig R Holsten D Lagae K Monllau J Crespo R Bulgheroni E
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INTRODUCTION

The purpose of this study is to report results from a prospective multicenter study of a bioresorbable type I collagen scaffold used to replace tissue loss following irreparable lateral meniscus injuries.

METHODS

49 non-consecutive patients (33M/16F; mean age 30.5 yrs, range 14.7–54.7 yrs) with irreparable lateral meniscus tears or loss requiring surgical treatment were prospectively enrolled at one of 7 EU centers. 11 patients (22%) had acute injuries of the lateral meniscus, while 38 (78%) had prior surgeries to the involved meniscus. Implantation of the LCMI (now Lateral Menaflex) was performed arthroscopically using an all-inside suturing technique (FASTFIX) combined with inside-out sutures in the more anterior meniscus aspect. Forty-three patients were evaluated with a 2 to 4-year follow-up (FU); mean FU duration was 45 months (range, 33–53 m). Patients were evaluated clinically and by self-assessment using Tegner activity and Lysholm function scores, as well as the Visual Analog Scales (VAS) for pain, and a satisfaction questionnaire. Evaluations were performed pre-operatively, 6 months, 1 year, 2 and 4 years after surgery. X-ray and/or MR-images were taken pre-operatively, and at 1 year and 2 years after surgery.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 198 - 198
1 Sep 2012
Kon E Vannini F Marcacci M Buda R Filardo G Cavallo M Ruffilli A Giannini S
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Osteocondritis dissecans (OCD) is a relatively common cause of knee pain. Ideal treatment is still controversial. Aim of this exhibit is to describe the outcomes of 5 different surgical techniques in a series of 63 patients.

63patients (age 22.5±7.4 years) affected by OCD of the femoral condyle (45 medial and 17 lateral) were treated by either osteochondral autologous transplantation, autologous chondrocyte implantation with bone graft, biomimetic nanostructured osteochondral scaffold (Maioregen) implantation, bone-cartilage paste graft or bone marrow derived cells transplantation “one-step” technique. Patient evaluation included IKDC score, eq-vas score, X-Rays and MRI preoperatively and at follow-up.

Global mean IKDC improved from pre-operative 40.1±14.6 to 77.2±21.3 (p<0.0005) at mean 5.3±4.7 years follow-up, while eq-vas improved from 51.7±17.0 to 83.5±18.3(p<0.0005). No influence of age, size of the lesion, length of follow-up and associated surgeries on the result was found. No differences were found between the results obtained with different surgeries except a slight tendency of better improvement in the result following autologous chondrocyte implantation (p<0.01). Control MRI evidenced a satisfactory repair of cartilaginous layer and subchondral bone.

The techniques described were effective in providing good clinical and radiographic results in the treatment of OCD and confirmed the validity of autologous chondrocyte implantation over time. Newer techniques such as Maioregen implantation and “one-step” base on different rationales, the first relying on the characteristics of the scaffold and the second on the regenerative potential of mesenchymal cells. Both of them have the advantages to be minimally invasive surgeries and to require a single operation.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 144 - 144
1 Sep 2012
Bruni D Raspugli G Iacono F Lo Presti M Zaffagnini S Marcacci M
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Background

The reported outcomes of unicompartmental knee replacement (UKR) for spontaneous osteonecrosis of the knee (SPONK) often derive from small series with an average followup of 5 years, enabling to generate meaningful conclusions. Therefore, we determined the long-term functional results and the 10-years survivorship of the implant in all patients with advanced SPONK of the medial tibio-femoral compartment treated with a unicompartmental knee arthroplasty at our institute.

Methods

We retrospectively evaluated 84 consecutive patients with late stage SPONK. All patients received a pre-operative MRI to confirm the diagnosis, to exclude any metaphyseal involvement and to assess the absence of significative degenerative changes in the lateral and PF compartment. Mean age at surgery was 66 years and mean body mass index (BMI) was 28.9. In all cases, SPONK involved the medial compartment; in 77 cases the medial femoral condyle (MFC) was involved, while in 7 cases the pathology site was the medial tibial plateau (MTP). Radiological evaluation was conducted by 3 different radiologists and clinical evaluation according to KSS and WOMAC score was performed by 3 fellows from outside institutions, with no previous clinical contact with the patients, at a mean followup of 98 months.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 375 - 375
1 Sep 2012
Zaffagnini S Marcheggiani Muccioli GM Bonanzinga T Signorelli C Lopomo N Bignozzi S Bruni D Nitri M Bondi A Marcacci M
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INTRODUCTION

This study aimed to intra-operatively quantify the improvements in knee stability given both by anatomic double-bundle (ADB) and single-bundle with additional lateral plasty (SBLP) ACL reconstruction using a navigation system.

MATERIALS AND METHODS

We prospectively included 35 consecutive patients, with an isolated anterior cruciate ligament injury, that underwent both ADB and SBLP ACL reconstruction (15 ADB, 20 SBLP). The testing protocol included anterior/posterior displacement at 30° and 90° of flexion (AP30–AP90), internal/external rotation at 30° and 90° of flexion (IE 30–IE90) and varus/valgus test at 0° and 30° of flexion (VV0–VV30); pivot-shift (PS) test was used to determine dynamic laxity. The tests were manually performed before and after the ACL reconstruction and the data were acquired by means a surgical navigation system (BLU-IGS, Orthokey, USA). Comparisons of pre- and post-reconstruction laxities were made using paired Student t-test (P=0.05) within the same group; comparison between ADB and SBLP groups was indeed performed using independent Student t-test (P=0.05), analysing both starting pre-operative condition and post-operative one.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 103 - 103
1 Sep 2012
Colle F Bignozzi S Lopomo N Zaffagnini S Marcacci M
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Introduction

Several in vitro and in vivo studies have found correspondence between transepicondylar axis (TEA) and functional flexion axis (FFA) in healthy subjects. In addition some studies suggest that the use of FFA for rotational alignment of femoral implant may be more accurate than TEA. Ostheoarthritis (OA) may modify limb alignment and therefore flexion axis, introducing a bias at different flexion ranges during kinematic acquisition. In this study we want to understand whether OA affects somehow the FFA evaluation compared to TEA and whether the FFA could be considered a usable reference for implant positioning for osteoarthritic knees

Methods

We included a group of 111 patients undergoing TKA. With a navigation system, we recorded intraoperative kinematic data in three different ranges of motion (0°-120°; 35°-80°; 35°-120°). We compared the difference in orientation of FFA (computed with the mean helical axis method) in the three ranges as also the difference with the TEA on frontal and axial planes. The correlation of preoperative limb deformity with FFA and TEA was also performed.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 140 - 140
1 Sep 2012
Muccioli GMM Zaffagnini S Lopomo N Bruni D Nitri M Bonanzinga T Grassi A Ravazzolo G Molinari M Rimondi E Marcacci M
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Purpouse

We hypothesized that patients receiving a medial collagen meniscus implant (MCMI) would show better clinical, radiograpich and Magnetic Resonanace Imaging (MRI) outcomes than patients treated with partial medial meniscectomy (PMM) at minimum 10 year FU.

Material and Methods

Thirty-three non-randomized patients (males, mean age 40 years) were enrolled in the study to receive a MCMI (17 patients) or as control treated with a PMM (16 patients).

All of them were clinically evaluated at time zero, 5 and minimum 10 years after surgery (mean FU 133 months, range 120–145) by Lysholm, VAS for pain, objective IKDC knee form and Tegner activity level. SF-36 score was performed pre-operatively and at final FU.

Bilateral weight-bearing XRays were executed at time zero and at final FU. Minimum 10 years FU MRI images were compared with collected pre-operative MRI images by means of Yulish score. Genovese score was also used to evalute MCMI MRI survivorship.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 183 - 183
1 Jun 2012
Patella S Kon E Filardo G Martino AD D'Orazio L Matteo BD Zaffagnini S Marcacci M
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INTRODUCTION

Osteochondral defects are still a challenge for the orthopaedic surgeon, since most of the current surgical techniques lead to fibrocartilage formation and poor subchondral regeneration, often associated to joint stiffness and/or pain.

Thinking of the ideal osteochondral graft from both the surgical an commercial point of view, it should be an off-the-shelf product; this is the research direction and the explanation for the new biomaterials recently proposed to repair osteochondral defect inducing an “in situ” cartilage regeneration starting from the time of the implantation into the defect site.

For the clinical pilot study we performed, a newly developed nanostructured biomimetic scaffold was used to treat chondral and osteochondral lesions of the knee; its safety and manageability, as much as the surgical procedure reproducibility and the clinical outcome, were evaluated in order to test its intrinsic potential without any cells colture aid.

MATERIALS AND METHODS

A new osteochondral scaffold was obtained by enucleating equine collagen type 1 fibrils with hydroxyapatite nanoparticles in 3 different layers with 3 different gradient ratios at physiological conditions.

30 patients (9F, 21M, mean age 29,3yy) affected by either chondral or osteochondral lesions of the knee (8 medial femoral condyles, 5 lateral femoral condyles, 12 patellae, 8 femoral throcleas) underwent the scaffold implantation from January to July 2007. The sizes of the lesions were in between 2 and 6 squared cm. All patients and their clinical outcome were analyzed prospectively at 6, 12, 24 and 36 months using the Cartilage standard Evaluation Form as proposed by ICRS and an high resolution MRI.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 184 - 184
1 Jun 2012
Patella S Kon E Martino AD Filardo G Zaffagnini S D'Orazio L Matteo BD Marcacci M
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INTRODUCTION

The menisci play a fundamental biomechanical role in the knee and also help in the maintaining of the articular homeostasis; thus, either a lesion or the complete absence of the menisci can invalidate the physiological function of the knee causing important damages, even at long term. Unfortunately, meniscal tears are often found during the ordinary orthopaedic practice while the regenerative potential of this kind of tissue is very low and limited to its peripheral-vascularized part; this is why the majority of these common arthroscopic findings are not reparable and often the surgeon is almost forced to perform a partial, subtotal or even total meniscectomy, regardless of the well-known consequences of this kind of surgery.

MATERIALS AND METHODS

Recently a porous, biodegradable scaffold made of an aliphatic polyurethane (Actifit(tm),Orteq Ltd) has been developed for the arthroscopic treatment of partial and irreparable meniscal tears; thanks to its particular structure, this scaffold facilitates the regeneration of the removed meniscal part, preventing the potential cartilage damage due to its complete or partial lack.

We performed a prospective clinical study on 17 patients affected by a massive loss of meniscal substance either medial or lateral associated with intraarticular or global knee pain and/or swelling.

We analyzed the patient both clinically and by using the International Knee Document Committee's (IKDC) Subjective and Objective Knee Evaluation Form. We also assessed the sport activity resumption by comparing the Tegner score at the time of the very first visit with the presurgery and prelesional ones. Finally, we also organized a control MRI at 6 and 12 months after surgery.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 8 | Pages 1060 - 1064
1 Aug 2011
Zaffagnini S Bonanzinga T Muccioli GMM Giordano G Bruni D Bignozzi S Lopomo N Marcacci M

We have shown in a previous study that patients with combined lesions of the anterior cruciate (ACL) and medial collateral ligaments (MCL) had similar anteroposterior (AP) but greater valgus laxity at 30° after reconstruction of the ACL when compared with patients who had undergone reconstruction of an isolated ACL injury. The present study investigated the same cohort of patients after a minimum of three years to evaluate whether the residual valgus laxity led to a poorer clinical outcome.

Each patient had undergone an arthroscopic double-bundle ACL reconstruction using a semitendinosus-gracilis graft. In the combined ACL/MCL injury group, the grade II medial collateral ligament injury was not treated. At follow-up, AP laxity was measured using a KT-2000 arthrometer, while valgus laxity was evaluated with Telos valgus stress radiographs and compared with the uninjured knee. We evaluated clinical outcome scores, muscle girth and time to return to activities for the two groups.

Valgus stress radiographs showed statistically significant greater mean medial joint opening in the reconstructed compared with the uninjured knees (1.7 mm (sd 0.9) versus 0.9 mm (sd 0.7), respectively, p = 0.013), while no statistically significant difference was found between the AP laxity and the other clinical parameters. Our results show that the residual valgus laxity does not affect AP laxity significantly at a minimum follow up of three years, suggesting that no additional surgical procedure is needed for the medial collateral ligament in combined lesions.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 103 - 103
1 May 2011
Giordano G Zaffagnini S Zarbà V Presti ML Nitri M Bruni D Delcogliano M Muccioli GM Marcacci M
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Traumatic anterior shoulder dislocation and sub-luxation are common injuries. But few studies have compared arthroscopic and open stabilization of the shoulder at long-term follow up. The purpose of our study is to show whether an arthroscopic approach to repair Bankart lesion can obtain the same results at long follow up as an open procedure. We analyzed 110 non-randomized consecutive shoulders in 110 patients who underwent a surgical repair of recurrent anterior shoulder instability between 1990 and 1999. Eighty-two patients were available at long term follow up (74,5% retrieval rate). In particular, 49 patients (59.8%) (group A) were treated with arthroscopic transglenoid suture (modified Caspari) between 1990 and 1995 (mean 15,7 year FU), whereas, 33 patients (40.2%) (group B) were treated with open repair between 1995 and 1999 (mean 12,7 year FU). We evaluated the patients in terms of failure rates, Rowe and UCLA scores. The failure cases in the forty-nine patients treated with arthroscopic suture were 13, six dislocations and seven subluxations. The group A had also a Rowe score: function 24.2+8.2, stability 42.4+13.9, range of movement 18.6+3.8, total score 85.0+22.46. The UCLA score was: pain 8.8+1.7, function 8.6+2.1, muscle power 9.2+1.6, total score 26.4+4.8. Of the thirty-three patients treated with open repair, three had at least one post-op dislocations and four felt sometimes subluxations. The Rowe score in group B was: function 23.6+9.7, stability 41.2+14.9, range of movement 18.3+3.9, total score 83.2+24.4. Moreover the UCLA score was: pain 8.8+1.9, function 8.8+1.9, muscle power 9.2+1.2, total score 26.9+4.2. We showed that both techniques were fairly good in treatment of shoulder instability. In our series no significant difference was observed in redislocation rate and in Rowe and UCLA scores between the two groups. The recurrence rate (subluxations and dislocations) was high in both groups: the arthroscopic group had 26.5% and the open one had 21.2%. Our recurrence rate following open repair was higher than in many studies, while the rate after arthroscopic transglenoid procedure was almost equivalent. We hypothesize that one of the reasons for these higher recurrence rates may be the long term follow up. Another cause could be our decision to include subluxation as a failure value, even if there is no agreement about. In fact we believe it to be an important disability factor in sport as in life activities. After surgery, most of the patients returned to their preinjuried activities. But at long term follow up almost all patients have stopped high level sport activity. Moreover, at this long term follow up, some patients told us a feeling of muscle weakness in the last years. In conclusion patients had good impressions about their shoulders thanks to surgery, but also because of lower functional demand.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 211 - 211
1 May 2011
Colle F Bignozzi S Lopomo N Zaffagnini S Sun L Marcacci M
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Introduction: Several in vitro and in vivo studies have found correspondence between transepicondylar axis (TEA) and mean helical axis (MHA) in healthy subjects. In addition some studies suggest that the use of MHA for rotational alignment of femoral implant may be more accurate than TEA. Ostheoarthritis (OA) may modify limb alignment and flexion axis, introducing a bias during kinematic acquisition. An in-vivo study comparing normal and osteoarthritic knees using MHA is still lacking. The purposes of this study were: to understand whether arthritis affects somehow the functional axis evaluation and then to assess whether the MHA could be considered as reference flexion axis also for osteoarthritic knees; starting from hypothesis that there is a correspondence between TEA and MHA, to evaluate whether in pathologic subjects there still is the same correspondence.

Material and Methods: We included a group of 15 OA patients undergoing TKA and, as control group, 60 patients that underwent ACL reconstruction, since in vivo studies reported small differences in kinematics between ACL reconstructed and uninjured limbs. With a surgical navigation system we recorded intraoperative kinematic data of different passive ranges of motion (PROM) and calculated the MHA applying a least square approach to the set of finite helical axes (FHA) obtained in three different ranges of motion (0°–120°; 35°–80°; 35°–120°). We compared the difference in orientation of MHA in the three ranges with respect to the TEA on frontal (XZ) and axial (XY) planes. The correlation of preoperative limb deformity with MHA-TEA angle was also performed.

Results: The results of difference of MHA-TEA angle between the OA and ACL groups for all the three ranges of flexion and in XZ and XY views showed no statistical difference (p=0.5188; p=0.7147 respectively). No statistical difference was found also about MHA-TEA angle between the three ranges in frontal and axial views (ANOVA p=0.6373; p=0.4183 respectively). There was no difference between the flexion and extension movements in the three ranges. We also found that correlation between limb alignment and MHA-TEA angle showed good correlation (r> 0.54, p< 0.001) in frontal view and fair correlation (r< 0.37, p< 0.05) in axial view for all ranges.

Conclusions: Our work has demonstrated that pathologic knees shows no differences in MHA orientation compared to nearly healthy subjects, moreover there is the same correspondence between TEA and MHA both in XZ and XY plane. We also found that preoperative limb alignment does not correlate with MHA-TEA angle. results are in agreement to studies on healthy subjects. Therefore the MHA may be considered a reliable reference for determining femoral flexion axis and a useful tool in the determination of femoral implant positioning on axial plane, even in surgical setup on osteoarthritic patients.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 502 - 502
1 Oct 2010
Bruni D Giordano G Marcacci M Muccioli GM Russo A Zaffagnini S
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We performed a clinical, instrumental and radiographic study on a highly homogeneous series of 100 consecutive patients with unilateral ACL lesion at 7 years of minimum follow up, alternatively assigned to a single bundle reconstruction using patellar tendon (PT) or to a double bundle reconstruction using hamstrings (DB). Mean Tegner score was 4,8 for PT and 6,5 for DB (p=0,0005). Time for sport resumption was 6,6 months for PT and 3,8 months for DB (p=0,0052). There were no significative differences between the two groups regarding range of motion and functional subjective self-evaluation. Mean anterior displacement at instrumental evaluation performed with KT2000 showed no significative differences between the two groups. Objective clinical evaluation with IKDC was superior for DB group (A=86,5%; B=13,5%) respect to PT group (A=18,7%; B=75%; C=6,3%) (p< 0,0001). We found no differences regarding anterior knee pain between and Ahlback radiographic score the two groups and we have observed no recurrence of instability after surgical treatment. Double bundle ACL reconstruction with hamstrings has showed higher results respect to single bundle ACL reconstruction with patellar tendon in terms of Tegner score, IKDC, time for sport resumption.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 534 - 535
1 Oct 2010
Bruni D Iacono F Marcacci M Muccioli GM Russo A Zaffagnini S
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We performed a retrospective clinical and radiographic evaluation of 100 cases operated in our institute between February 1996 and March 2003 with a mean follow-up of 60 months to assess the efficiency of UKR performed with a new minimally invasive technique. The aim of this study is to correlate the clinical outcome of the patients with the pre- and post-op alignment, and with implant positioning on coronal and sagittal plane.

100 patients (23 ♂, 64 ♀) underwent cemented UKR (De Puy Preservation Uni with all poly tibial component), both for arthritis and osteonecrosis. At the pre-op clinical and radiographic evaluation, 82 patients presented a varus deformity, 5 patients a valgus deformity. The Hospital for Special Surgery Score (HSS) was used to determine the subjective and objective clinical status of the patients before and after the intervention.

Pre-op antero-posterior (AP) x-rays of the knee were executed to establish the femoro-tibial angle (FTA) and the angle between the affected tibial plateau and the tibial anatomical axis (PTA), while latero-lateral (LL) x-rays were performed to determine the posterior tibial slope (PS). To analyze ligamentous balancing, x-rays were performed both in supine and in plain weight bearing stance. Post-op, we performed supine AP e LL X-rays and at a mean follow-up of sixty months (12–84 months) we performed AP and LL plain weight bearing x-rays.

We considered a knee with FTA > 175° as varus knee, 170°< FTA< 175° as normal knee and an FTA < 170° as valgus knee. Moreover, we assumed a TPA > 90° for valgus knee and a TPA< 90° for varus knee.

According with HSS scoring system, at a mean follow-up of 60 months, 63 (76%) cases were excellent (100-85 points), 15 (18%) cases were good (84-70 points), 5 (6%) bad results (< 60 points). Our results demonstrate that patients with a pre-operative varus alignment of 7 degrees are slightly more likely to be selected for UKR. In our series, patients with an excellent clinical result presented pre-operatively a mean varus deformity of 7,9°. According to literature, we demonstrated that a small amount of undercorrection with a residual varus deformity of 3–5° is the goal to be reached in order to avoid both rapid degeneration of the non-replaced compartment as well as the premature loosening of the replaced compartment. We performed a mean axial correction of 5,1° leaving a mean axial varus deformity of 2,8° in the excellent group. In our series the group with excellent results also showed a post-operative PTS of 7,1°, while mean pre-operative PTS was 6,6°. Moreover, the further our radiographic findings were from the optimal position suggested, the worst were the results : a decrease was evident comparing excellent group with good group and this was even more marked comparing excellent group with bad results group.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 622 - 622
1 Oct 2010
Zaffagnini S Gold G Lindsey D Lopomo N Marcacci M Safran M Vaughn Z
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Introduction: The hip joint is usually considered a ball-in-socket. However, there have been few studies evaluating normal hip kinematics and the contribution coming from soft tissues. Capsular laxity is at the basis of injury to the acetabular labrum (most common pathological lesion seen during hip arthroscopy). The objectives of this study were to (1) assess hip kinematics with all the soft tissues intact using a surgical navigation system, (2) assess the relative contributions of the soft tissues to hip stability and (3) assess the relative contributions of periarticular soft tissues to hip range of motion.

Materials and Methods: We used 4 normal hemicorpse specimens for a total of 8 hips. A navigation system (KLEE, Orthokey) was used to acquire the kinematic data. The anatomical reference system was identified through the palpation of landmarks: (1) anterior superior iliac spines (ASIS) and (2) pelvic tubercles for the pelvis, (3) femoral head center and (4) epicondyles for femur. There were 12 passive kinematic tests repeated 3 times in 3 different limb conditions (‘intact’, ‘no-skin-muscle’, ‘labral tear’) to explore the whole kinematic range. We analysed the differences in flexion/extension, abduction/adduction, internal/external rotation ranges (Wilcoxon’s Signed Ranks Test).

Results: The kinematic analysis applied on the limbs highlighted the following range of motion: (1) the F/E was 115.7 ± 2.4° (12.9 ± 1.0° in extension/101.7 ± 3.0° in flexion) in ‘intact’ limb, 139.2 ± 10.8° (14.7 ± 2.7° in extension/120.7 ± 8.6° in flexion) in ‘no-skin no-muscle’ condition, and 174.3 ± 34.1° (25.3 ± 0.5° in extension/147.4 ± 35.4° in flexion) in ‘capsule cut’ condition; all the ranges were statistically different (p < 0.05); (2) the A/A was 44.5 ± 13.7° (35.4 ± 1.5° in abduction/10.1 ± 13.4° in adduction) in ‘intact’ limb, 59.2 ± 1.8° (38.5 ± 3.2° in abduction/21.7 ± 0.7° in adduction) in ‘no-skin no-muscle’ condition, and 82.0 ± 4.6° (57.4 ± 2.5° in abduction/25.6 ± 6.8° in adduction) in ‘capsule cut’ condition; all the ranges were statistically different (p < 0.05); (3) the IR/ER was 52.2 ± 10.5° (32.0 ± 11.9° in IR/21.5 ± 1.0° in ER) in ‘intact’ limb, 59.2 ± 1.8° (36.1 ± 14.1° in IR/26.5 ± 1.2° in ER) in ‘no-skin no-muscle’ condition, and 116.4 ± 54.4° (58.2 ± 16.1° in IR/55.6 ± 36.3° in ER) in the ‘capsule cut’ condition; all the ranges were statistically different (p < 0.05), except the ranges of ‘intact’ condition and ‘no-skin no-muscles’ one (p = 0.37).

Discussion: The study of the 3 different conditions highlighted the critical role of the soft tissues in hip stability and kinematics; the soft tissues do provide stability mainly in limiting hip range of motion. This study’s findings are a preliminary contribution in the understanding of the contribution of periarticular muscles, joint capsule and ligaments to hip kinematics.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 540 - 540
1 Oct 2010
Marcacci M Bruni D Di Martino A Giordano G Iacono F Lo Presti M Zaffagnini S
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Arthroscopic selective resurfacing of the knee may be considered a treatment option for selected patients with focal articular damage.

From more than 2 years in IX Division of Rizzoli Orthopaedics Institute(Bologna- Italy) we use, in selected cases with only one articular compartment damaged, an innovative resurfacing prosthesis.

We mad a new design of focal resurfacing (MAIOR) that is possible to implant with arthroscopic technique and that realize both mini-invasive and mini-traumatic surgery.

The fixation method of the MAIOR allows higher osteointegration by biomaterials and hydrossiapatite of new generation that permit a press-fit fixation of the implant.

The new philosophy of this implant consist of early focal treatment with low compromise of bone. Many surgeons, in case of focal articular damage, prefer to attend to made an unique definitive surgical operation when the degenerative changes are more severe.

This new implant permit to substitute, also in arthroscopic technique, only the articular damage and to avoid to attend a more important and diffuse articualr damage.

It is an uncemented, focal resurfacing prosthesis that requires minimal bone sacrifice and utilizes a minimal invasive surgical (MIS) approach with or without arthroscopic assistance.

In a prospective and consecutive study, 78 patients were followed up at least for 12 months. Subjective pain and joint function were assessed using Visual analogue scale (VAS) and Knee society scores respectively. The preliminary results are interesting and encouraging with subjective evaluation equal to 85% of normal knee.

Significant reduction of pain and improvement in joint function was observed. Although, long term study will determine the real performance of the prosthesis, trend seems to be positive.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 509 - 509
1 Oct 2010
Zaffagnini S Berbig R Bulgheroni P Crespo R Holsten D Koen CL Marcacci M Juan CM
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Introduction: The Collagen Meniscus Implant (CMI) has been shown to be effective for the replacement of lost medial meniscus tissue; however, no such device has been available for treatment of similar injuries to the lateral meniscus. Loss of the lateral meniscus results in a rapidly increased rate of knee degeneration compared to similar medial injuries. The purpose of this study was to determine if a CMI developed for use in treatment of lateral meniscus deficiencies is as safe and effective as has been reported for the medial CMI.

Methods: Prospectively, 60 patients (12–65 years of age) were enrolled at 7 sites between March 2006 and October 2007. Patients had irreparable lateral meniscus tears requiring partial meniscectomy. The knee had to be ligamentously stable and in neutral alignment and with no untreated Grade IV cartilage damage. Patients gave informed consent and agreed to comply with postoperative assessments and standardized rehabilitation. The surgical technique involved insertion of the dry implant into the lateral compartment of the knee joint. Fixation of the implant to the host meniscus rim was accomplished with either an all-inside suture technique or a hybrid all-inside/inside-out technique. Clinical evaluations and patient self-assessments were conducted preoperatively and at defined intervals through 2 years postoperatively. Procedure specific intraoperative parameters, radiographic evaluations, and adverse events were documented. Data collection was monitored by a third party according to GCP regulations.

Results: 49 patients received a lateral CMI. Currently, 24 patients have 1-year follow-up and 13 patients have been followed approximately 2 years; the mean follow-up is 22 months. Follow-up included assessments of changes in Lysholm, pain, Tegner and patient satisfaction. All patients showed clinical improvement from the preoperative to the 1 year postoperative time points. Four patients experienced adverse events which required an additional arthroscopic procedure between 4 and 16 months and included removal of implant remnants, synovectomy and debridement.

Conclusions: These preliminary results appear to suggest that implantation of lateral CMI leads to improved clinical outcomes in pain, function, self-assessment and activity levels. Frequency and type of adverse events are comparable to those for suture repair reported in the literature. Based on results reported for the medical CMI, we anticipate that these lateral CMI patients will have improved long-term results compared to partial lateral meniscectomy.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 502 - 502
1 Oct 2010
Bignozzi S Lo Presti M Lopomo N Marcacci M Zaffagnini S
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Introduction: Anterior Cruciate Ligament (ACL) is primary constrain to anterior displacement of tibia with respect to the femur and secondary to internal/external (IE) and varus/valgus (VV) rotations; an ACL reconstruction should thus control not only AP but also IE and VV laxities. For this reasons, more attention has given to residual rotational instability. This study aims to verify if those subjects with high of pre-op knee laxities has also high post-op laxity after an ACL reconstruction.

Material and Methods: The study includes 115 patients, that underwent ACL reconstructions between January 2005 and September 2007. Patients with associated severe ligaments tears or severe chondral defects were excluded. The joint passive kinematics was intra-operatively assessed using the BLU-IGS system (Orthokey, Delaware). We evaluated, before and after the reconstruction, the manual maximum IE rotation at 30° and 90° of flexion, VV rotation at 0° and 30° of flexion and AP displacement at 30° and 90° of flexion. We used the k-means algorithm applied to pre-op values to create two groups among the patients: the GROUP H, with higher pre-op laxity and the GROUP L, with lower pre-op laxity. The pre-op groups were compared for each test using independent Student’s t-test (p=0.01) in order to assess their difference. Student’s t-test (p=0.01) was performed on the corresponding post-op values in order to verify if the difference between H and L was maintained after the reconstruction.

Results: Mean pre-op VV at 0° was 7.1±0.9° for group H and 4.7±0.8° for group L (p< 0.01), post-op was 3.2±0.8° for group H and 2.5±0.8° for group L (p< 0.01). Mean pre-op VV at 30° was 6.2±1.5° for group H and 3.4±0.7° for group L (p< 0.01), post-op was 3.4±1.3° for group H and 2.2± 0.9° for group L (p< 0.01). Mean pre-op IE at 30° was 28.3±3.5° for group H and 19.2±3.1° for group L (p< 0.01), post-op was 21.5±3.8° for group H and 14.7±3.7° for group L (p< 0.01). Mean pre-op IE at 90° was 31.3±2.8° for group H and 22.4±3.5° for group L (p< 0.01), post-op was 22.3±4.0° for group H and 17.0±4.4° for group L (p< 0.01). Mean pre-op AP at 30° was 14.5±2.1mm for group H and 8.9±1.6mm for group L (p< 0.01), post-op was 6.2±1.6mm for group H and 4.2±1.6mm for group L (p< 0.01). Mean pre-op AP at 90° was 11.2±1.7mm for group H and 6.7±1.4mm for group L (p< 0.01), post-op was 5.4±1.8mm for group H and 3.4±1.3mm for group L (p< 0.01).

Discussion: The comparison between group H and group L showed that those patients with higher pre-op laxity had maintained higher post-op values mainly for all the tests. This finding is probably correlated to the possible presence of different tears affecting soft structures of the joint and to the proper and specific anatomy of each patient.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 397 - 397
1 Sep 2009
Casino D Martelli S Iacono F Zaffagnini S Lopomo N Bignozzi S Marcacci M
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Information on knee kinematics during surgery is currently lacking. The aim of this study is to describe intra-operative kinematics evaluations during uni-compartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA) by mean of a navigation system. Anatomical and kinematic data were acquired by Kin-Nav navigation system and analysed by a dedicated elaboration software developed at our laboratory. The study was conducted on 20 patients: 10 patients undergoing mini-invasive UKA and 10 patients undergoing posterior-substituting-rotating-platform TKA. In both group of patients the surgeon performed passive knee flexion immediately before and immediately after the prosthetic implant. Pattern and amount of internal/external tibial rotation in function of flexion were computed and significant changes between before and after implant were evaluated adopting Student’s t-test (significant level p=0.05).

UKA implant did not significantly change the pattern of internal/external tibial rotation, nor the total magnitude of tibial rotation (15.75°±7.27°) during range of flexion (10°–110°), compared to pre-operative values (17.87°±7.34°, p=0.25). Magnitude of tibial rotation in TKA group before surgery (8.00°±3.67°) was significantly less compared to UKA patients and did not changed significantly after implant (5.96°±4.88°, p=0.09). Pattern of rotation before and after TKA implant were different between each other and between pattern in UKA patients both before and after implant.

Intra-operative evaluations on tibial rotation during knee flexion confirmed some assumptions on knee implants from post-operative methods and suggest a more extensive use of surgical navigation systems for kinematic studies.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_III | Pages 397 - 397
1 Sep 2009
Martelli S Iacono F Zaffagnini S Bignozzi S Lopomo N Casino D Marcacci M
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Total knee arthroplasty (TKA) is actually a satisfactory technique to reduce pain and enhance mobility in osteoartritic pathologies (OA) of the knee. However, life of the implant is strictly dependent on restoration of correct knee kinematics, as alteration of motion pattern could led to abnormal wear in prosthetic components and also damage soft tissues. The aim of our study was to evaluate new kinematic tests to be performed during surgery in order to improve the standard intra-operative evaluation of the outcome on the individual case. We used Kin-Nav navigation system to acquire anatomic and kinematic data, which were analysed by a dedicated elaboration software developed at our laboratory. Ten patients undergoing rotating platform cruciate substituting TKA were considered for this study. Immediately before the implant and immediately after component positioning, the surgeon performed 3 complete knee flexion imposing internal tibial rotation (IPROM) and 3 complete knee flexion imposing external tibial rotation (EPROM). Tibial rotation during IPROM and EPROM tests was plotted in function of flexion (in the range 10°–110°). Repeatability of IPROM and EPROM was tested by calculating ICC (Intra-class Correlation Coefficient) between 3 repeated curves. Distance between IPROM curve and EPROM curve was computed at various degree of flexion. Maximum distance obtained during all range of flexion before and after the implant were compared by Student’s t-test (significant level p=0.05).

ICC for repeated motions were 0.99 for IPROM and 0.98 for EPROM. Maximum distance between tibial rotation in IPROM and EPROM was 27.82±6.98 before implant and significantly increased (p=0.001) to 40.09±6.92 after TKA. In one case we observed that the value remained similar before and after implant (from 33.11 to 33.98) while in one case we observed very large increase of rotation (from 30.56 to 50.01).

The proposed kinematic tests were able to quantify the increase of tibial rotation after TKA implant. Future development of the study are encouraging and will include a larger sample and reflections on individual findings.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 266 - 266
1 May 2009
Zaffagnini S Iacono F Casino D Lopomo N Bignozzi S Martelli S Marcacci M
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Aims: This work describes a new intraoperative computer-assisted method for the evaluation of joint kinematics in both total (TKA) and uni-compartmental (UKA) knee arthroplasty. We report schematically the protocol and the preliminary in-vivo results we obtained on 11 patients (9 UKA – 2 TKA).

Methods: The system consists of an optoelectronic localizer, 2 reference arrays and a dedicated acquisition software, that permits the real-time control of limb position and allows the acquisition of joint motions. After a first phase of registration (anatomical landmarks identification) the surgeon executes, both before and after the reconstruction, a series of passive tests: range of motion (PROM) evaluation, varus-valgus (VV) stress at 0°, and VV at 30°. Furthermore the surgeon can acquire also anatomical surfaces (tibial plateaus, femoral condyles, prosthetic components, etc.). The 3D kinematic evaluations and anatomical data are recorded before and after the joint reconstruction. This new methodology has been used during 11 interventions fulfilled at our institute. We compare the PROM results with literature, and we also analyzed the interoperator repeatability in the execution of the tests (3 repetitions performed by a senior surgeon).

Results: The kinematic analysis of the PROM showed that there were no significant differences between per-operative and post-operative in all UKA cases. In the 2 TKR cases internal-external (IE) rotations appeared reduced after the implant, but further data are necessary to have a statistical evidence. The extension was improved both in UKA and TKA. The VV laxity at 0 ° was significantly reduced (p < 0.001), while at 30 ° stayed constant (p = 0.010). In all the TKR cases the evaluation of contact areas between femoral and tibial components showed normal pattern, and in UKA the contacts remain inside the prosthesis areas. Measured kinematic parameters (knee rotations, screw-home mechanism and alignment) were comparable with literature and manual estimation at surgical time.

Conclusions: The proposed protocol optimizes surgical times and minimizes invasiveness. The preliminary results showed that the system is able to quantify new kinematic parameters during intraoperative evaluations, provides data about alignments, gaps, stability and 3D motions of the individual knee and therefore can allow an accurate and real-time estimation of the passive knee function. Moreover the new 3D anatomical and kinematic data can improve the biomechanical understanding of the pathological and prosthetic knees.