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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 117 - 117
23 Feb 2023
Zhou Y Shadbolt C Rele S Spelman T Dowsey M Choong P Schilling C
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Utility score is a preference-based measure of general health state – where 0 is equal to death, and 1 is equal to perfect health. To understand a patient's smallest perceptible change in utility score, the minimal clinically important difference (MCID) can be calculated. However, there are multiple methods to calculate MCID with no consensus about which method is most appropriate. The aim of this study is to calculate MCID values for the Veterans-RAND 12 (VR12) utility score using varying methods. Our hypothesis is that different methods will yield different MCID values.

A tertiary institutional registry (SMART) was used as the study cohort. Patients who underwent unilateral TKA for osteoarthritis from January 2012 to January 2020 were included. Utility score was calculated from VR12 responses using the standardised Brazier's method. Distribution and anchor methods were used for the MCID calculation. For distribution methods, 0.5 standard deviations of the baseline and change scores were used. For anchor methods, the physical and emotional anchor questions in the VR12 survey were used to benchmark utility score outcomes. Anchor methods included mean difference in change score, mean difference in 12 month score, and receiver operating characteristics (ROC) analysis with the Youden index.

Complete case analysis of 1735 out of 1809 eligible patients was performed. Significant variation in the MCID estimates for VR12 utility score were reported dependent on the calculation method used. The MCID estimate from 0.5 standard deviations of the change score was 0.083. The MCID estimate from the ROC analysis method using physical or emotional anchor question improvement was 0.115 (CI95 0.08-0.14; AUC 0.656).

Different MCID calculation methods yielded different MCID values. Our results suggest that MCID is not an umbrella concept but rather many distinct concepts. A general consensus is required to standardise how MCID is defined, calculated, and applied in clinical practice.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 118 - 118
23 Feb 2023
Zhou Y Dowsey M Spelman T Choong P Schilling C
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Approximately 20% of patients feel unsatisfied 12 months after primary total knee arthroplasty (TKA). Current predictive tools for TKA focus on the clinician as the intended user rather than the patient. The aim of this study is to develop a tool that can be used by patients without clinician assistance, to predict health-related quality of life (HRQoL) outcomes 12 months after total knee arthroplasty (TKA).

All patients with primary TKAs for osteoarthritis between 2012 and 2019 at a tertiary institutional registry were analysed. The predictive outcome was improvement in Veterans-RAND 12 utility score at 12 months after surgery. Potential predictors included patient demographics, co-morbidities, and patient reported outcome scores at baseline. Logistic regression and three machine learning algorithms were used. Models were evaluated using both discrimination and calibration metrics. Predictive outcomes were categorised into deciles from 1 being the least likely to improve to 10 being the most likely to improve.

3703 eligible patients were included in the analysis. The logistic regression model performed the best in out-of-sample evaluation for both discrimination (AUC = 0.712) and calibration (gradient = 1.176, intercept = −0.116, Brier score = 0.201) metrics. Machine learning algorithms were not superior to logistic regression in any performance metric. Patients in the lowest decile (1) had a 29% probability for improvement and patients in the highest decile (10) had an 86% probability for improvement.

Logistic regression outperformed machine learning algorithms in this study. The final model performed well enough with calibration metrics to accurately predict improvement after TKA using deciles. An ongoing randomised controlled trial (ACTRN12622000072718) is evaluating the effect of this tool on patient willingness for surgery. Full results of this trial are expected to be available by April 2023.

A free-to-use online version of the tool is available at smartchoice.org.au.


Bone & Joint Research
Vol. 10, Issue 12 | Pages 797 - 806
8 Dec 2021
Chevalier Y Matsuura M Krüger S Traxler H Fleege† C Rauschmann M Schilling C

Aims

Anchorage of pedicle screw rod instrumentation in the elderly spine with poor bone quality remains challenging. Our study aims to evaluate how the screw bone anchorage is affected by screw design, bone quality, loading conditions, and cementing techniques.

Methods

Micro-finite element (µFE) models were created from micro-CT (μCT) scans of vertebrae implanted with two types of pedicle screws (L: Ennovate and R: S4). Simulations were conducted for a 10 mm radius region of interest (ROI) around each screw and for a full vertebra (FV) where different cementing scenarios were simulated around the screw tips. Stiffness was calculated in pull-out and anterior bending loads.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 50 - 50
1 Feb 2021
Sanchez E Schilling C Grupp T Giurea A Verdonschot N Janssen D
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Introduction

Cementless total knee arthroplasty (TKA) implants use an interference fit to achieve fixation, which depends on the difference between the inner dimensions of the implant and outer dimensions of the bone. However, the most optimal interference fit is still unclear. A higher interference fit could lead to a superior fixation, but it could also cause bone abrasion and permanent deformation during implantation. Therefore, this study aims to investigate the effect of increasing the interference fit from 350 µm to 700 µm on the primary stability of cementless tibial implants by measuring micromotions and gaps at the bone-implant interface when subjected to two loading conditions.

Methods

Two cementless e.motion® tibial components (Total Knee System, B. Braun) with different interference fit and surface coating were implanted in six pairs of relatively young human cadaver tibias (47–60 years). The Orthoload peak loads of gait (1960N) and squat (1935N) were applied to the specimens with a custom made load applicator (Figure 1A). The micromotions (shear displacement) and opening/closing gaps (normal displacement) were measured with Digital Image Correlation (DIC) in 6 different regions of interest (ROIs - Figure 1B). Two General Linear Mixed Models (GLMMs) were created with micromotions and interfacial gaps as dependent variables, bone quality, loading conditions, ROIs, and interference fit implants as independent variables, and the cadaver specimens as subject variables.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 3 - 3
1 Dec 2020
Grupp TM Schilling C Fritz B Reyna ALP Pfaff A Taunt C Mihalko WM
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Introduction

Beneath infection, instability and malalignment, aseptic tibial component loosening remains a major cause of failure in total knee arthroplasty (TKA) [1]. This emphasizes the need for stable primary and long-term secondary fixation of tibial baseplates. To evaluate the primary stability of cemented tibial baseplates, different pre-clinical test methods have been undergone: finite element analysis [2], static push-out [3,4] or dynamic compression-shear loading [5] until interface failure. However, these test conditions do not reflect the long-term endurance under in vivo loading modes, where the tibial baseplate is predominantly subjected to compression and shear forces in a cyclic profile [5,6].

To distinguish between design parameters the aim of our study was to develop suitable pre-clinical test methods to evaluate the endurance of the implant-cement-bone interface fixation for tibial baseplates under severe anterior (method I) and internal-external torsional (method II) shear test conditions.

Materials & Methods

To create a clinically relevant cement penetration pattern a 4th generation composite bone model was customised with a cancellous core (12.5 PCF cellular rigid PU foam) to enable for high cycle endurance testing. VEGA System® PS & Columbus® CRA/PSA ZrN-multilayer coated tibial baseplates (2×12) were implanted in the customised bone model using Palacos® R HV bone cement (Figure 1).

An anterior compression-shear test (method II) was conducted at 2500 N for 10 million cycles and continued at 3000 N & 3500 N for each 1 million cycles (total: 12 million cycles) simulating post-cam engagement at 45° flexion. An internal-external torsional shear test (method II) was executed in an exaggeration of clinically relevant rotations [7,8] with ±17.2° for 1 million cycles at 3000 N tibio-femoral load in extension. After endurance testing either under anterior shear or internal-external torsion each tibial baseplate was mounted into a testing frame and maximum push-out strength was determined [3].


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 69 - 69
1 Feb 2020
Kebbach M Geier A Darowski M Krueger S Schilling C Grupp T Bader R
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Introduction

Persistent patellofemoral (PF) pain is a common postoperative complication after total knee arthroplasty (TKA). In the USA, patella resurfacing is conducted in more than 80% of primary TKAs [1], and is, therefore, an important factor during surgery. Studies have revealed that the position of the patellar component is still controversially discussed [2–4]. However, only a limited number of studies address the biomechanical impact of patellar component malalignment on PF dynamics [2]. Hence, the purpose of our present study was to analyze the effect of patellar component positioning on PF dynamics by means of musculoskeletal multibody simulation in which a detailed knee joint model resembled the loading of an unconstrained cruciate-retaining (CR) total knee replacement (TKR) with dome patella button.

Material and Methods

Our musculoskeletal multibody model simulation of a dynamic squat motion bases on the SimTK data set (male, 88 years, 66.7 kg) [5] and was implemented in the multibody dynamics software SIMPACK (V9.7, Dassault Systèmes Deutschland GmbH, Gilching, Germany). The model served as a reference for our parameter analyses on the impact on the patellar surfacing, as it resembles an unconstrained CR-TKR (P.F.C. Sigma, DePuy Synthes, Warsaw, IN) while offering the opportunity for experimental validation on the basis of instrumented implant components [5]. Relevant ligaments and muscle structures were considered within the model. Muscle forces were calculated using a variant of the computed muscle control algorithm. PF and tibiofemoral (TF) joints were modeled with six degrees of freedom by implementing a polygon-contact model, enabling roll-glide kinematics. Relative to the reference model, we analyzed six patellar component alignments: superior-inferior position, mediolateral position, patella spin, patella tilt, flexion-extension and thickness. The effect of each configuration was evaluated by taking the root-mean-square error (RMSE) of the PF contact force, patellar shift and patellar tilt with respect to the reference model along knee flexion angle.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 24 - 24
1 Apr 2019
Hettich G Schierjott RA Schilling C Maas A Ramm H Bindernagel M Lamecker H Grupp TM
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Introduction

Acetabular bone defects are still challenging to quantify. Numerous classification schemes have been proposed to categorize the diverse kinds of defects. However, these classification schemes are mainly descriptive and hence it remains difficult to apply them in pre-clinical testing, implant development and pre-operative planning. By reconstructing the native situation of a defect pelvis using a Statistical Shape Model (SSM), a more quantitative analysis of the bone defects could be performed. The aim of this study is to develop such a SSM and to validate its accuracy using relevant clinical scenarios and parameters.

Methods

An SSM was built on the basis of segmented 66 CT dataset of the pelvis showing no orthopedic pathology. By adjusting the SSM's so called modes of shape variation it is possible to synthetize new 3D pelvis shapes. By fitting the SSM to intact normal parts of an anatomical structure, missing or pathological regions can be extrapolated plausibly.

The validity of the SSM was tested by a Leave-one-out study, whereby one pelvis at a time was removed from the 66 pelvises and was reconstructed using a SSM of the remaining 65 pelvises. The reconstruction accuracy was assessed by comparing each original pelvis with its reconstruction based on the root-mean-square (RMS) surface error and five clinical parameters (center of rotation, acetabulum diameter, inclination, anteversion, and volume). The influence of six different numbers of shape variation modes (reflecting the degrees of freedom of the SSM) and four different mask sizes (reflecting different clinical scenarios) was analyzed.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 125 - 125
1 Apr 2019
Sanchez E Schilling C Grupp TM Verdonschot N Janssen D
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Introduction

Although cementless press-fit femoral total knee arthroplasty (TKA) components are routinely used in clinical practice, the effect of the interference fit on primary stability is still not well understood. Intuitively, one would expect that a thicker coating and a higher surface roughness lead to a superior fixation. However, during implant insertion, a thicker coating can introduce more damage to the underlying bone, which could adversely influence the primary fixation. Therefore, in the current study, the effect of coating thickness and roughness on primary stability was investigated by measuring the micromotions at the bone-implant interface with experimental testing.

Methods

A previous experimental set-up was used to test 6 pairs of human cadaveric femurs (47–60 years, 5 females) implanted with two femoral component designs with either the standard e.motion (Total Knee System, B. Braun, Germany) interference fit of 350 µm (right femurs) or a novel, thicker interference fit of 700 µm (left femurs). The specimens were placed in a MTS machine (Figure 1) and subjected to the peak loads of normal gait (1960N) and squat (1935N), based on the Orthoload dataset for Average 75.

Varus/valgus moments were incorporated by applying the loads at an offset relative to the center of the implants, leading to a physiological mediolateral load distribution. Under these loads, micromotions at the implant-bone interface were measured using Digital Image Correlation (DIC) at different regions of interest (ROIs – Figure 1). In addition, DIC was used to measure opening and closing of the implant-bone interface in the same ROIs.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 128 - 128
1 Apr 2019
Kebbach M Geier A Darowski M Krueger S Schilling C Grupp TM Bader R
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Introduction

Total knee replacement (TKR) is an established and effective surgical procedure in case of advanced osteoarthritis. However, the rate of satisfied patients amounts only to about 75 %. One common cause for unsatisfied patients is the anterior knee pain, which is partially caused by an increase in patellofemoral contact force and abnormal patellar kinematics. Since the malpositioning of the tibial and the femoral component affects the interplay in the patellofemoral joint and therefore contributes to anterior knee pain, we conducted a computational study on a cruciate-retaining (CR) TKR and analysed the effect of isolated femoral and tibial component malalignments on patellofemoral dynamics during a squat motion.

Methods

To analyse different implant configurations, a musculoskeletal multibody model was implemented in the software Simpack V9.7 (Simpack AG, Gilching, Germany) from the SimTK data set (Fregly et al.). The musculoskeletal model comprised relevant ligaments with nonlinear force-strain relation according to Wismans and Hill-type muscles spanning the lower extremity. The experimental data were obtained from one male subject, who received an instrumented CR TKR. Muscle forces were calculated using a variant of the computed muscle control algorithm. To enable roll-glide kinematics, both tibio- and patellofemoral joint compartments were modelled with six degrees of freedom by implementing a polygon-contact-model representing the detailed implant surfaces. Tibiofemoral contact forces were predicted and validated using data from experimental squat trials (SimTK). The validated simulation model has been used as reference configuration corresponding to the optimal surgical technique. In the following, implant configurations, i.e. numerous combinations of relative femoral and tibial component alignment were analysed: malposition of the femoral/tibial component in mediolateral (±3 mm) and anterior-posterior (±3 mm) direction.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 148 - 148
1 Mar 2009
Grupp T Yue J Garcia R Cocchi P Schilling C Cristofolini L Blömer W
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Introduction: Degenerative disc desease is one of the most frequently encountered spinal disorders. The intervertebral disc is a complex anatomic and functional structure, which makes the development of an efficient artificial disc a challenge [1].

Based on the complexity of the anatomical structures and the nearly unknown loading conditions at the moment only contradictory knowledge exists about the kinematics after TDA and in particular the location of the center of rotation in the human lumbar spine [2].

The objective of our study was to evaluate the kinematics of the human lumbar spine and the ability of TDA to restore the native conditions in regard to range of motion (ROM), neutral zone (NZ) and center of rotation (COR).

Material and Methods: In-vitro flexibility testing on functional spinal units (FSU) out of 12 fresh frozen lumbar spines has been performed. The FSU (L2/L3 and L4/L5) were tested first in the native condition, followed by nucleotomy and partial annulus resection and also after TDA with activ L (lumbar artificial disc, Aesculap Germany).

Therefore a spinal simulator has been customized, applying pure moments for flexion/extension, lateral bending and axial rotation (+/−7.5Nm) and axial preload (FP=400N) with a defined velocity (1°/s). The instantaneous COR has been calculated based on the velocity pole method using a 3D ultrasonic motion analysis system, measuring the twelve components of motion.

Results: The TDA with activ L leads to a good restoration of ROM and NZ in all loading directions under in-vitro flexibility testing. The instantaneous COR is exemplary described for the native condition under flexion/ extension in the sagittal plane. For the native condition the COR is located in the center of the inferior vertebral endplate. After nucleotomy the COR shifts dorsally into the region of the spinal cord and a significant grade of instability has been measured.

After insertion of the lumbar artificial disc the instability can be reduced to the native grade of motion and the COR is located again in the main axis of the spinal column in the upper third of the inferior vertebra.

Conclusion: The instantaneous COR has been estimated in-vitro for the different loading situations in the human lumbar spine before and after TDA. Based on the newly introduced method further optimizations of TDA devices can be undergone in regard to the particular aspect of physiological kinematics.