3D printing acetabular cups offers the theoretical advantage of enhanced bony fixation due to greater design control of the porous implant surfaces. Analysing retrieved 3D printed implants can help determine whether this design intent has been achieved.

We sectioned 14 off-the-shelf retrieved acetabular cups for histological analysis; 7 cups had been 3D printed and 7 had been conventionally manufactured. Some of the most commonly used contemporary designs were represented in both groups, which were removed due to either aseptic loosening, unexplained pain, infection or dislocation. Clinical data was collected for all implants, including their age, gender, and time to revision.

Bone ingrowth was evaluated using microscopic assessment and two primary outcome measures: 1) bone area fraction and 2) extent of bone ingrowth.

The additively manufactured cups were revised after a median (IQR) time of 24.9 months (20.5 to 45.6) from patients with a median (IQR) age of 61.1 years (48.4 to 71.9), while the conventional cups had a median (IQR) time to revision of 46.3 months (34.7 to 49.1, p = 0.366) and had been retrieved from patients with a median age of 66.0 years (56.9 to 68.9, p = 0.999).

The additively and conventionally manufactured implants had a median (IQR) bone area fraction of 65.7% (36.4 to 90.6) and 33.9% (21.9 to 50.0), respectively (p < 0.001).

A significantly greater amount of bone ingrowth was measured into the backside of the additively manufactured acetabular cups, compared to their conventional counterparts (p < 0.001). Bone occupied a median of 60.0% and 5.7% of the porous depth in the additively manufactured and conventional cups, respectively.

3D printed components were found to achieve a greater amount of bone ingrowth than their conventionally manufactured counterparts, suggesting that the complex porous structures generated through this manufacturing technique may encourage greater osteointegration.

3D printing is rapidly being adopted by manufacturers to produce orthopaedic implants. There is a risk however of structural defects which may impact mechanical integrity. There are also no established standards to guide the design of bone-facing porous structures, meaning that manufacturers may employ different approaches to this. Characterisation of these variables in final-production implants will help understanding of the impact of these on their clinical performance.

We analysed 12 unused, final-production custom-made 3D printed acetabular cups that had been produced by 6 orthopaedic manufacturers. We performed high resolution micro-CT imaging of each cup to characterise the morphometric features of the porous layers: (1) the level of porosity, (2) pore size, (3) thickness of porous struts and (4) the depth of the porous layers. We then examined the internal cup structures to identify the presence of any defects and to characterise: (1) their total number, (2) volume, (3) sphericity, (4) size and (5) location.

There was a variability between designs in the level of porosity (34% to 85%), pore size (0.74 to 1.87mm), strut thickness (0.28 to 0.65mm), and porous layer depth (0.57 to 11.51mm). One manufacturer printed different porous structures between the cup body and flanges; another manufacturer printed two differing porous regions within the cup body.

5 cups contained a median (range) of 90 (58–101) defects. The median defect volume was 5.17 (1.05–17.33) mm3. The median defect sphericity and size were 0.47 (0.19–0.65) and 0.64 (0.27–8.82) mm respectively. The defects were predominantly located adjacent to screw holes, within flanges and at the transition between the flange and main cup body; these were between 0.17 and 4.66mm from the cup surfaces.

There is a wide variability between manufacturers in the porous titanium structures they 3D print. The size, shape and location of the structural defects identified are such that there may be an increased risk of crack initiation from them, potentially leading to a fracture. Regulators, surgeons, and manufacturers should be aware of this variability in final print quality.

Aims

Acetabular edge-loading was a cause of increased wear rates in metal-on-metal hip arthroplasties, ultimately contributing to their failure. Although such wear patterns have been regularly reported in retrieval analyses, this study aimed to determine their in vivo location and investigate their relationship with acetabular component positioning.

Aims

The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices.

Aims

The main advantage of 3D-printed, off-the-shelf acetabular implants is the potential to promote enhanced bony fixation due to their controllable porous structure. In this study we investigated the extent of osseointegration in retrieved 3D-printed acetabular implants.

Aims

The optimum clearance between the bearing surfaces of hip arthroplasties is unknown. Theoretically, to minimize wear, it is understood that clearances must be low enough to maintain optimal contact pressure and fluid film lubrication, while being large enough to allow lubricant recovery and reduce contact patch size. This study aimed to identify the relationship between diametrical clearance and volumetric wear, through the analysis of retrieved components.

Background

Over 30 million people run marathons annually. The impact of marathon running on hips is unclear with existing literature being extremely limited (only one study of 8 runners).

Introduction

The achieved anteversion of uncemented stems is to a large extent limited by the internal anatomy of the bone. A better understanding of this has recently become an unmet need because of the increased use of uncemented stems.

We aimed to assess plan compliance in six degrees of freedom to evaluate the accuracy of PSI and guides for stem positioning in primary THAs.

Introduction

Three-dimensional (3D) printing of porous titanium implants marks a revolution in orthopaedics, promising enhanced bony fixation whilst maintaining design equivalence with conventionally manufactured components. No retrieval study has investigated differences between implants manufactured using these two methods. Our study was the first to compare these two groups using novel non-destructive methods.

Introduction

The use of Additive Manufacturing (AM) to 3D print titanium implants is becoming widespread in orthopaedics, particularly in producing cementless porous acetabular components that are either custom-made or off-the-shelf; the primary design rationale for this is enhanced bony fixation by matching the porosity of bone. Analysis of these retrieved components can help us understand their performance; in this study we introduce a non-destructive method of the retrieval analysis of 3D printed implants.

Objectives

The Attune total knee arthroplasty (TKA) has been used in over 600 000 patients worldwide. Registry data show good clinical outcome; however, concerns over the cement-tibial interface have been reported. We used retrieval analysis to give further insight into this controversial topic.

Objectives

Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event.

Objectives

The Precice nail is the latest intramedullary lengthening nail with excellent early outcomes. Implant complications have led to modification of the nail design. The aim of this study was to perform a retrieval study of Precice nails following lower-limb lengthening and to assess macroscopical and microscopical changes to the implants and evaluate differences following design modification, with the aim of identifying potential surgical, implant, and patient risk factors.

Introduction

Modular-neck hips have twice the rate of revision compared to fixed stems. Metal related pathology is the second most common reason for revision of implants featuring titanium stems with cobalt chrome necks. We aimed to understand the in-vivo performance of current designs and explore the rationale for their continued use.

Introduction

Numerous studies have reported on clinically significant volumes of material loss and corrosion at the head-stem junction of metal-on-metal (MOM) hips; less is understood about metal-on-polyethylene (MOP) hips. We compared the effect of bearing type (MOM vs MOP) on taper material loss for a hip system of a single design (DePuy Pinnacle).

Aims

The aim of this study was to determine whether patients with metal-on-metal (MoM) arthroplasties of the hip have an increased risk of cardiac failure compared with those with alternative types of arthroplasties (non-MoM).

Additive manufacturing has enabled a radical change in how surgeons reconstruct massive acetabular defects in revision hip surgery. We report on the early clinical and radiological results from our methods for surgical planning, design, and implantation of 3D printed trabecular titanium implants in a cohort of patients with large unclassifiable pelvic defects.

We set up a prospective investigation involving 7 consecutive patients. Inclusion criteria was the following: 1) A history of previous total hip replacement; and 2) Current imaging showing at least a Paprosky 3B defect. Planned acetabular inclination and version was 40° and 20° respectively. Post operatively all patients had a CT scan which was analysed with software to determine component position and compared to planned. Outpatient review was done at 2 weeks (For wound), 6 weeks (for weight bearing and fixation) and 52 weeks (for fixation and infection) post-operative.

The median age at surgery was: 65 years (40–78). The median bone defect volume was 140cm³. Median surgery length was 5.2 hours (3–6.25). Median blood loss was 1300mL (450– 2000). Radiologically, components were stable and no screw breakages were identified. Achieved inclination was 41.0° (29.0–55.6) and achieved version was 15.8° (3.8–43.6). Median Oxford Hip score improved from 9 (2–44) to 25 (18–32).

We have demonstrated a new series of pre, intra and post-operative methods for reconstruction of unclassifiable acetabular bony defects. Initial clinical and radiological results are excellent considering the severity of the bony defects. We recommend the use of our or similar methods when trying to reconstruct these defects.

Dual mobility (DM) cups are designed to improve stability, however have been associated with increased risk of impingement that can ultimately result in intraprosthetic dislocation. It is speculated that the femoral neck plays a role in their performance. We investigated the effect of neck topography on the wear of new-generation liners.

This was a retrieval study involving 70 DM cups implanted with liners made of highly crosslinked polyethylene and paired with two neck types: either highly polished (n=35) or rough necks (n=35). The median time of implantation was 30 months.

The rim edge of all inserts was investigated by two examiners for evidence of contact with the femoral neck, presenting as deformation of the polyethylene. A high precision roundness machine and micro-CT scans of the components were used to measure the size of the deformations observed.

28 of the 35 (80%) DM liners paired with rougher necks had evidence of neck impingement resulting in a raised lip, whilst 8 out of 35 (23%) liners paired with smooth necks had a raised lip; this difference was significant (p<0.0001). The repeatability and the inter-observer reproducibility of the deformation scores was found to be substantial κ >0.70. The height of the raised rims of the DM cups paired with rough necks had a median (range) of 139 µm (72–255), whilst had a median (range) of 52 µm (45–90) with smooth necks, the difference between the groups was significant (p<0.0001).

Liner rim deformation resulting from contact with the femoral neck likely begins during early in-vivo function.

Rough necks can increase the damage on the polyethylene rim in dual-mobility bearing, which may lead to loss of the retentive power of these components over time.

Several implants have a proven track record of durability and function in patients over many years. As manufacturers' patents expire it is understandable that cheaper generic copies would be considered. There is currently no established, independent method of determining design equivalence between generic and branded orthopaedic implants.

We acquired 10 boxed, as manufactured components consisting of the generic OptiStem XTR model (n=5) and branded Exeter (n=5) femoral stems. Two examiners were blinded to the implant design and independently measured the mass, volume, trunnion surface topography, roughness, trunnion cone angle, CCD angle and femoral offset using peer-reviewed methods. We then compared the stems using these parameters.

We found that the OptiStems (1) were lighter (p<0.001) (2) had a rougher trunnion surface (p<0.001) with a greater spacing and depth of the machined threads (p<0.001), (3) had greater trunnion cone angles (p=0.007) and (4) a smaller radius at the top of the trunnion (p=0.007). There was no difference for stem volume (p=0.643), CCD angle (p=0.788) or offset (p=0.993).

This study is the first independent investigation of the equivalence of a generic orthopaedic implant to its branded design. We found a clear difference in trunnion roughness, trunnion cone angle and radius, and implant mass when comparing the two generic and branded stem designs. All implants require standard regulatory processes to be followed. It does not appear feasible that generic implants can be manufactured to predictability guarantee the same performance as generic drugs.

We found a number of physical differences between the generic and branded implants. Whilst both designs are likely to work in clinical practice, they are different.

Introduction

The Precice nail is the latest intramedullary lengthening nail with excellent early outcomes. Implant complications have led to modification of the nail design. The aim of this study was to perform a retrieval study of Precice nails following lower limb lengthening. To assess macroscopic and microscopic changes to the implants and assess differences following design modification, with identification of potential surgical, implant and patient risk factors.

Dual-taper implants provide surgeons with options to optimise patients' anatomy intraoperatively but are at risk of early revision due to adverse tissue reactions to corrosion debris. Risk factors for failure and linkage with symptoms however are not fully understood. We related retrieval findings to clinical and implant variables.

This study involved 88 failed dual-taper implants with TMZF femoral stems and cobalt-chromium necks, revised for pain, elevated Co (median = 7.3μg/L) and Cr (median = 2.15μg/L) ions levels and fluid collection on MRI.

Stem-neck surfaces were assessed for: 1) severity of corrosion using a published visual method and 2) severity of material lost and location of damage with a roundness-measuring machine. Five traces were taken on each round section of the taper surface at 45° increments to compute the relative depth of damage. The total area of these traces provided a measure of surface damage for comparative purposes.

The stem-neck taper junctions were severely corroded; the deepest areas of damage were on the inferior-proximal and superior-distal part of the necks, compatible with cantilever bending. Elemental analysis revealed chromium rich deposits indicative of corrosion processes and metal transfer from the stem to the neck.

There was a positive correlation between the severity of damage and time of implantation (p<0.0001). Co and Cr levels in the blood were also strongly correlated (p<0.0001, p=0.0002). No other implant or patient variables were linked.

The stem-neck junction was severely corroded in all cases. The severity and location of the areas of surface damage did not link with implant or patient characteristics in this big cohort suggesting that the design and material combination is the predominant source of failure in these designs.

Dual-taper hips are severely corroded at the stem-neck junction; this appears to be due to the use of a TMZF alloy stem paired with CoCrMo necks.

Trunnionosis, due to mechanical wear and/or corrosion at the head stem taper junction, can occur in metal on polyethylene (MOP) hip implants. In some patients this results in severe soft tissue destruction or Adverse Reaction to Metal Debris (ARMD). The amount of material required to cause ARMD is unknown but analyses of retrieved hips may provide the answer to this clinically important question.

We collected implants from 20 patients with failed hips with MOP bearings, revised due to ARMD. We collected clinical, imaging and blood test data. We graded the severity of taper corrosion (1 to 4), and quantified the volume of material loss from this junction. We compared our results with previous data collected for metal-on-metal (MOM) hips.

The median time to revision of the MOP hips was 51.3 (23.1–56.4) months. All head tapers were moderately to severely corroded with a median corrosion score of 4. The median (range) of total material loss at the taper of the MOP hips was 3.9 mm³ (2.96 – 7.85 mm³) and the material loss rate was 1.4 mm³ / year (0.56 – 1.82).

Comparison with MOM hips revealed no significant difference in taper material loss (p=0.7344) with a median rate of 0.81 mm³ / year (0.01–3.45).

We are the first to quantify the volume of material loss at the head taper of hip implants with MOP bearings that were revised due to trunnionosis. This data indicates that a clinically significant dose of cobalt and chromium to induce ARMD is approximately 1.4 mm³ / year.

We have identified a clinically significant volume of taper material loss in MOP hips.

Total hip arthroplasties are known to corrode predominantly at the taper junctions between Cobalt Chromium Molybedenum (CoCrMo) and Titanium (Ti) alloy components.

We aimed to understand the modes underlying clinically significant tissue reactions to metals from corroded implants by determining: (1) what type of metal is present in the tissues, (2) which cells contain the metal species and (3) how this compares with results from metal-on-metal (MOM) hip resurfacings (HRs).

This study involved periprosthetic tissue from patients that had undergone revision surgery due to adverse reactions to metal debris (ARMD) from dual-taper prostheses consisting of Ti-based alloy stems paired with CoCrMo necks. We used Synchrotron micro X-ray Fluorescence Spectroscopy (µXRF) and micro X-ray Absorption Near Edge Spectroscopy (µXANES) for detection of Co, Cr and Ti, and determination of their oxidation state.

Synchrotron radiation has shown that the chromium in tissues is Cr₂O₃ when derived from corroded CoCrMo/Ti junctions beside the CrPO₄ species found when hip implants release CoCrMo nanoparticles from their bearing surfaces (MoM HRs). Presence of Cr₂O₃ was associated with titanium oxide TiO₂. This may be the outcome of the chemical interaction between the two species. Histological examination showed corrosion products present within viable macrophages and in the extracellular connective tissue, Figure 1.

Understanding corrosion at taper junctions and the pathogenesis of the biological response is of significant clinical importance. This is the first study to co-register histology and metal distribution maps and to explore the potential synergy effect of CoCrMo with Ti alloy.

This study provides guidance for toxicological studies on wear/corrosion particles, how they stimulate the host response and the cellular mechanisms involved in the pathogenesis of ARMD.

For any figures or tables, please contact the authors directly by clicking on ‘Info & Metrics’ above to access author contact details.

Objectives

The use of ceramic femoral heads in total hip arthroplasty (THA) has increased due to their proven low bearing wear characteristics. Ceramic femoral heads are also thought to reduce wear and corrosion at the head-stem junction with titanium (Ti) stems when compared with metal heads. We sought to evaluate taper damage of ceramic compared with metal heads when paired with cobalt chromium (CoCr) alloy stems in a single stem design.

Aims

The aim of this study was to compare the design of the generic OptiStem XTR femoral stem with the established Exeter femoral stem.

Background

Surgeons are waiting for a hassle free, time saving, precise and accurate guide for hip arthroplasty. Industry are waiting for instruments to reduce manufacturing costs associated with washing, assembling, sterilization and transportation. Patient specific / custom made surgical guides may deliver these goals but current systems have had limited assessments.

We comprehensively assessed a new guiding system for the acetabular component of hip replacement, “Bullseye”.

Objectives

Mechanical wear and corrosion at the head-stem junction of total hip arthroplasties (THAs) (trunnionosis) have been implicated in their early revision, most commonly in metal-on-metal (MOM) hips. We can isolate the role of the head-stem junction as the predominant source of metal release by investigating non-MOM hips; this can help to identify clinically significant volumes of material loss and corrosion from these surfaces.

Osteoarthritis (OA) affects bone cartilage and underlying bone. Mechanically, the underlying bone provides support to the healthy growth of the overlying cartilage. However, with the progress of OA, bone losses and cysts occur in the bone and these would alter the biomechanical behaviour of the joint, and further leading to bone remodelling adversely affect the overlying cartilage.

Human femoral head and femoral condyle were collected during hip or knee replacement operation due to the end stage of osteoarthritis (age 50–70), and the cartilage patches were graded and marked. A volunteer patient, with minor cartilage injury in his left knee while the right knee is intact, was used as control. Peripheral quantitative computed tomography (pQCT) was used to scan the bone and to determine the volumetric bone mineral density (vBMD) distribution.

The examination of retrieved tissue explants from osteoarthritic patients revealed that patches of cartilage were worn away from the articular surface, and patches of intact cartilage were left. The cysts, ranging from 1 to 10mm were existed in all osteoarthritic bones, and were located close to cartilage defects in the weight-bearing regions, and closely associated with the grade of cartilage defect as measured by pQCT. The bone mineral density (vBMD) distribution demonstrated that the bones around cysts had much higher vBMD than the trabecular bone away from the cysts. Compared to the subchondral bone under thicker cartilage, subchondral bone within cartilage defect has higher vBMD. This may result from the mechanical stimulation as a result of bone-bone direct contact with less protection of cartilage in cartilage defect regions.

This study showed an association between cartilage defect and subchondral bone mineral density distribution. Cysts were observed in all osteoarthritic samples and they are located close to cartilage defects in the weight-bearing regions. Cartilage defect altered the loading pattern of the joints, this leading to the bone remodelling and resultant bone structural changes as compared to the normal bone tissues.

This work was financially supported by The ARUK Proof of Concept Award (grant no: 21160).

Introduction

Surgical simulation and ‘virtual’ surgical tools are becoming recognised as essential aids for speciality training in Trauma & Orthopaedics, as evidenced by the BOA T&O Simulation Curriculum 2013^1,2. The current generation of hip arthroplasty simulators, including cadaveric workshops, offers the trainee limited exposure to reproducible real life bony pathology. We developed and implemented a novel training course using pathological dry bone models generated from real patient cases to support senior orthopaedic trainees and new consultants in developing knowledge and hands on skills in complex total hip arthroplasty.

Introduction

We report 10-year clinical outcomes of a prospective randomised controlled study on uni-compartmental knee arthroplasty using an active constraint robot.

Measuring the clinical impact of CAOS systems has generally been based around surrogate radiological measures with currently few long-term functional follow-up studies reported. We present 10 year clinical follow up results of robotic vs conventional surgery in UKA.

Aims

The National Joint Registry for England, Wales and Northern Ireland (NJR) has extended its scope to report on hospital, surgeon and implant performance. Data linkage of the NJR to the London Implant Retrieval Centre (LIRC) has previously evaluated data quality for hip primary procedures, but did not assess revision records.

Introduction

The National Joint Registry (NJR) for England, Wales and Northern Ireland contributes important information on the performance of implants and surgeons. However, the quality of this data is not known. This study aimed to perform an independent validation of primary metal-on-metal hip procedures recorded on the NJR through linkage to the London Implant Retrieval Centre (LIRC).

Introduction

Retrieved metal-on-metal acetabular components are invaluable resources from which to investigate the wear behaviour of failed hip implants. New forensic and investigative techniques continue to be developed to help the surgeon further understand factors which contribute to early failure. We have developed a novel technique to locate the in vivo location of the primary wear scar of an explanted cup.

Arthroplasty registries are important for the surveillance of joint replacements and the evaluation of outcome. Independent validation of registry data ensures high quality. The ability for orthopaedic implant retrieval centres to validate registry data is not known. We analysed data from the National Joint Registry for England, Wales and Northern Ireland (NJR) for primary metal-on-metal hip arthroplasties performed between 2003 and 2013. Records were linked to the London Implant Retrieval Centre (RC) for validation. A total of 67 045 procedures on the NJR and 782 revised pairs of components from the RC were included. We were able to link 476 procedures (60.9%) recorded with the RC to the NJR successfully. However, 306 procedures (39.1%) could not be linked. The outcome recorded by the NJR (as either revised, unrevised or death) for a primary procedure was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval linkage and correct assignment of outcome code improved over time. The rates of error for component reference numbers on the NJR were as follows: femoral head category number 14/229 (5.0%); femoral head batch number 13/232 (5.3%); acetabular component category number 2/293 (0.7%) and acetabular component batch number 24/347 (6.5%).

Registry-retrieval linkage provided a novel means for the validation of data, particularly for component fields. This study suggests that NJR reports may underestimate rates of revision for many types of metal-on-metal hip replacement. This is topical given the increasing scope for NJR data. We recommend a system for continuous independent evaluation of the quality and validity of NJR data.

Cite this article: Bone Joint J 2015;97-B:10–18.

There are several component position and design variables that increase the risk of edge loading and high wear in metal-on-metal hip resurfacing (MOM-HR). In this study we combined all of these variables to calculate the ‘contact patch to rim distance’ (CPRD) in patients undergoing revision of their MOM-HR. We then determined whether CPRD was more strongly correlated with component wear and blood metal ion levels, when compared to any other commonly reported clinical variable. This was a retrospective study of 168 consecutively collected MOM-HR retrieval cases. All relevant clinical data was documented, including pre-revision whole blood cobalt and chromium ion levels. Wear of the bearing surfaces was then measured using a roundness-measuring machine. We found four variables to be significantly (p < 0.05) correlated with component wear and blood metal ion levels: (1) cup inclination angle, (2) cup version angle, (3) arc of cover, and (4) CPRD. The correlations between CPRD and both wear and ion levels were significantly stronger than those seen with any other variable (all p < 0.0001). Our study has shown that CPRD is the best predictor of component wear and blood metal ion levels, and may therefore be a useful parameter to help determine those patients who are at risk of high wear and require more frequent clinical surveillance.

Introduction

Edge loading is a common wear mechanism in Metal-on-Metal (MOM) hip resurfacing and is associated with higher wear rates and the incidence of pseudotumour. The purpose of this study was to develop a method to investigate the contributions of patient, surgical and implant design variables on the risk of edge loading.

Improvements in the surgical technique of total knee replacement (TKR) are continually being sought. There has recently been interest in three-dimensional (3D) pre-operative planning using magnetic resonance imaging (MRI) and CT. The 3D images are increasingly used for the production of patient-specific models, surgical guides and custom-made implants for TKR.

The users of patient-specific instrumentation (PSI) claim that they allow the optimum balance of technology and conventional surgery by reducing the complexity of conventional alignment and sizing tools. In this way the advantages of accuracy and precision claimed by computer navigation techniques are achieved without the disadvantages of additional intra-operative inventory, new skills or surgical time.

This review describes the terminology used in this area and debates the advantages and disadvantages of PSI.

Introduction

Metal Artefact Reduction Sequence (MARS) MRI is being increasingly used to detect soft tissue inflammatory reactions surrounding metal-on-metal hip replacements. The UK MHRA safety alert announced in April 2010 recommended cross-sectional imaging such as MRI for all patients with painful MOM hips. The terms used to describe the findings include bursae, cystic lesions and solid masses. A recently used term, pseudotumour, incorporates all of these lesions. We aimed to correlate the pattern of abnormalities on MRI with clinical symptoms.

SUMMARY

We report a prospective study of clinical data collected pre, intra and post operation to remove both cup and head components of 118 failed, current generation metal on metal (MOM) hips. Whilst component position was important, the majority were unexplained failures and of these the majority (63%) had cup inclination angles of less than 55 degrees. Poor biocompatibility of the wear debris may explain many of the failures.

We measured the orientation of the acetabular and femoral components in 45 patients (33 men, 12 women) with a mean age of 53.4 years (30 to 74) who had undergone revision of metal-on-metal hip resurfacings. Three-dimensional CT was used to measure the inclination and version of the acetabular component, femoral version and the horizontal femoral offset, and the linear wear of the removed acetabular components was measured using a roundness machine.

We found that acetabular version and combined version of the acetabular and femoral components were weakly positively correlated with the rate of wear. The acetabular inclination angle was strongly positively correlated with the rate of wear. Femoral version was weakly negatively correlated with the rate of wear. Application of a threshold of > 5 μm/year for the rate of wear in order to separate the revisions into low or high wearing groups showed that more high wearing components were implanted outside Lewinnek’s safe zone, but that this was mainly due to the inclination of the acetabular component, which was the only parameter that significantly differed between the groups.

We were unable to show that excess version of the acetabular component alone or combined with femoral version was associated with an increase in the rate of wear based on our assessment of version using CT.

Introduction: The successful outcome from metal-on-metal hip resurfacing is partly dependent on the restoration of the natural biomechanics of the hip joint. Valid measurement of the geometry of the reconstructed hip is challenging using plain radiographs. CT is more accurate and precise yet rarely used to assess hip geometry. Our aims were 1) to quantify the agreement between radiographic and CT measurement of horizontal femoral offset (HFO); 2) to determine the relationship between HFO and patient gender and size; and 3) To compare HFO of the reconstructed hip to the contralateral hip.

Method: We used plain radiograph and CT data from 42 patients (23 male and 19 female) from a consecutive series with unilateral metal-on-metal hip resurfacings. We measured HFO of both hips (component and contralateral) using plain radiographs (with PACS) and CT (with Robin 3D software). Pelvic width and radial head sizes were measured on CT. Measurements were made in triplicate by 2 observers.

We graded the contralateral hip for severity of joint space narrowing on plain radiographs.

Results: There was considerable disagreement between CT and plain radiographs for HFO. HFO was statistically different between genders (p=0.0004). HFO correlated with femoral head radius (0.57, p=0.0002), but not patient size (for height (0.29, p=0.13), or pelvic width (0.25, p=0.11). There was a wide range of HFO of the contralateral hips that was comparable to the reconstructed hip.

Conclusion: To our knowledge this is the first study to show the importance of measuring HFO using CT. HFO was found to be correlated to gender and femoral head radius, but not with any other parameters of patient size. The wide range of offset was considerably greater than is available from current total hip replacement designs. Hip resurfacing may overcome this.

Introduction: Unicompartmental knee Arthroplasty (UKA) is a commonly used and accepted treatment for Osteoarthritis (OA) in the medial compartment. How-ever, despite some good results¹ there is still a reluctance to use this procedure in the lateral compartment for the same indications, as the procedure is considered technically difficult, and not as successful². This study reports the clinical outcome of lateral UKAs in comparison with medial UKAs, TKAs and a normal population group using a knee score designed to highlight the shortcomings of TKA³.

Methods: 20 consecutive patients over 2 years following lateral UKA were functionally assessed. They were compared with 3 groups of 20 age and sex matched patients: those who had undergone medial UKA or TKA in the same time period, or normal controls from an upper limb clinic. Clinical function was assessed at least 2 years postoperatively, using the ‘total knee questionaire’³. This consists of 55 scaled multiple choice questions. The score is derived from the product of three scales: the importance of a specific activity, the frequency with which it is undertaken, and the ease with a patient can perform it.

Results: 90% of the patients reported that they were either satisfied or very satisfied with their lateral UKA, with 95% of the patients in the medial UKA group and 75% in the TKA group reaching this level of satisfaction. The average Composite Score for the lateral UKA group was significantly better compared with the TKA group (p < 0, 05). (Kneeling – (5,72/4,45), Gardening – (7,32/5,18), Pivoting – (7,83/6,78) and Walking with heavy bags (8,2/5,97)). The Total Composite Score was significantly better (p< 0, 05) in Patients after lateral UKA (7,14) compared to patients who underwent TKA (5,99). No statistically significant differences in the Total Composite Score was found between both the lateral & medial UKA patients taken as a single group compared with the control group.

Conclusion: Lateral Unicompartmental Knee Arthroplasty achieves superior knee function in comparison to Total Knee Arthroplasty, so is worth considering as an option in for early OA of the lateral compartment.

Radiological measurements are an essential component of the assessment of outcome following knee arthroplasty. However, plain radiographic techniques can be associated with significant projectional errors because they are a two-dimensional (2D) representation of a three-dimensional (3D) structure. Angles that are considered within the target zone on one film may be outside that zone on other films. Moreover, these parameters can be subject to significant inter-observer differences when measured. The aim of our study therefore was to quantify the variability between observers evaluating plain radiographs following Unicompartmental knee arthroplasty.

Twenty-three observers, made up of Orthopaedic Consultants and trainees, were asked to measure the coronal and sagittal alignment of the tibial and femoral components from the post-operative long-leg plain radiograph of a Unicompartmental knee arthroplasty. A post-operative CT scan using the low dose Imperial knee protocol was obtained as well and analysed with 3D reconstruction software to measure the true values of these parameters. The accuracy and spread of the pain radiographic measurements were then compared with the values obtained on the CT.

On the femoral side, the mean angle in coronal alignment was 1.5° varus (Range 3.8, SD 1, min 0.1, max 3.9), whereas the mean angle in sagittal alignment was 8.6° of flexion (Range 7.5, SD 1.5, Min 3.7, Max 11.2). The true values measured with CT were 2.4° and 11.0° respectively. As for the tibial component, the mean coronal alignment angle was 89.7° (Range 11.6, SD 3.3, Min 83.8, Max 95.4), and the mean posterior slope was 2.4° (Range 8.7, SD 1.6, Min -2, Max 6.7). The CT values for these were 87.6° and 2.7° respectively.

We conclude that the plain radiographic measurements had a large scatter evidenced by the wide ranges in the values obtained by the different observers. If only the means are compared, the plain radiographic values were comparable with the true values obtained with CT (that is; accuracy was good) with differences ranging from 0.3° to 2.4°. The lack of precision can be avoided with the use of CT, particularly with the advent of low-dose scanning protocols.

We carried out metal artefact-reduction MRI, three-dimensional CT measurement of the position of the component and inductively-coupled plasma mass spectrometry analysis of cobalt and chromium levels in whole blood on 26 patients with unexplained pain following metal-on-metal resurfacing arthroplasty.

MRI showed periprosthetic lesions around 16 hips, with 14 collections of fluid and two soft-tissue masses. The lesions were seen in both men and women and in symptomatic and asymptomatic hips. Using three-dimensional CT, the median inclination of the acetabular component was found to be 55° and its positioning was outside the Lewinnek safe zone in 13 of 16 cases. Using inductively-coupled plasma mass spectrometry, the levels of blood metal ions tended to be higher in painful compared with well-functioning metal-on-metal hips.

These three clinically useful investigations can help to determine the cause of failure of the implant, predict the need for future revision and aid the choice of revision prostheses.

A Prospective, randomised controlled trial demonstrates superior outcomes using an active constraint robot compared with conventional surgical technique in unicompartmental knee arthroplasty (UKA). Computer assistance should extinguish outliers in arthroplasty, with robotic systems being able to execute the preoperative plan with millimetre precision.

We used the Acrobot system to deliver tailor made surgery for each individual patient. A total of 27 patients (28 knees) awaiting unicompartmental knee arthroplasty were randomly assigned to have the operation performed either with the assistance of the Acrobot or conventionally. CT scans were obtained with coarse slices through hips and ankles and fine slices through the knee joint. Preoperative 3D plans were made and transferred to the Acrobot system in theatre, or printed out as a conventional surgical aid. Accurate co-registration was confirmed, prior to the surfaces of the femur and tibia being milled. The outcome parameters included measurements of the American Knee Society (AKS) score and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index. These measurements were performed pre-operatively and at six, 18 weeks, and 18 months post-operatively. After 18 months two UKA out of the conventional trial (n =15) had been revised into a total knee replacement (TKA), whereas there were no revisions in the Acrobot trial group (n = 13).

Using an active constrained robot to assist the surgeon was significantly more accurate than the conventional surgical technique. This study has shown a direct correlation between accuracy and improvement in knee scores at 6, 18 weeks and 18 months after surgery. At 18 months there continues to be a significant improvement in the knee scores with again a marked correlation between radiological accuracy and clinical outcome with higher accuracy leading to better function based on the WOMAC and American Knee Society Score.

Whilst computer assistance enables more accurate arthroplasty to be performed, demonstrating this is difficult. The superior results of CAOS systems have not been widely appreciated because accurate determination of the position of the implants is impossible with conventional radiographs for they give very little information outside their plane of view.

We report on the use of low dose (approximately a quarter of a conventional pelvic scan), low cost CT to robustly measure and demonstrate the efficacy of computer assisted hip resurfacing. In this study we demonstrate 3 methods of using 3D CT to measure the difference between the planned and achieved positions in both conventional and navigated hip resurfacing.

The initial part of this study was performed by imaging a standard radiological, tissue equivalent phantom pelvis. The 3D surface models extracted from the CT scan were co-registered with a further scan of the same phantom. Subsequently both the femoral and acetabular components were scanned encased in a large block of ice to simulate the equivalent Hounsfield value of human tissue. The CT images of the metal components were then co-registered with their digital images provided by the implant manufactures. The accuracy of the co-registration algorithm developed here was shown to be within 0.5mm.

This technique was subsequently used to evaluate the accuracy of component placement in our patients who were all pre-operatively CT scanned. Their surgery was digitally planned by first defining the anterior pelvic plane (APP), which is then used as the frame of reference to accurately position and size the wire frame models of the implant. This plan greatly aids the surgeon in both groups and in the computer assisted arm the Acrobot Wayfinder uses this pre-operative plan to guide the surgeon.

Following surgery all patients, in both groups were further CT scanned to evaluate the achieved accuracy. This post-operative CT scan is co-registered to the pre-operative CT based plan. The difference between the planned and achieved implant positions is accurately computed in all three planes, giving 3 angular and 3 translational numerical values for each component.

Further analysis of the CT generated results is used to measure the implant intersection volume between the pre-operatively planned and achieved positions. This gives a single numerical value of placement error for each component. These 3D CT datasets have also been used to quantify the volume of bone resected in both groups of patients comparing the simulated resection of the planned position of the implant to that measured on the post-operative CT.

This study uses 3D CT as a surrogate outcome measure to demonstrate the efficacy of CAOS systems.

Last year at CAOS UK we reported on the development of the Acrobot® Navigation System for accurate computer-assisted hip resurfacing surgery. This paper describes the findings of using the system in the clinical setting and includes the improvements that have been made to expedite the procedure. The aim of our system is to allow accurate planning of the surgery and precise placement of the prosthesis in accordance with the plan, with a zero intra-operative time penalty in comparison to the standard non-navigated technique.

The system uses a pre-operative CT-based plan to allow the surgeon to have full 3D knowledge of the patient’s anatomy and complete control over the sizes and positions of the components prior to surgery.

At present the navigation system is undergoing final clinical evaluation prior to a clinical study designed to demonstrate the accuracy of outcome compared with the conventional technique. Whilst full results are not yet available, this paper describes the techniques that are being used to evaluate accuracy by comparing pre-operative CT-based plans with post-operative CT scans, and gives initial results.

This approach provides a true measure of procedure outcome by measuring what was achieved against what was planned in 3D. The measure includes all the sources of error present within the procedure protocol, therefore these results represent the first time that the outcome of a navigated orthopaedic procedure has been measured accurately.

Surgeons need to be able to measure angles and distances in three dimensions in the planning and assessment of knee replacement. Computed tomography (CT) offers the accuracy needed but involves greater radiation exposure to patients than traditional long-leg standing radiographs, which give very little information outside the plane of the image.

There is considerable variation in CT radiation doses between research centres, scanning protocols and individual scanners, and ethics committees are rightly demanding more consistency in this area.

By refining the CT scanning protocol we have reduced the effective radiation dose received by the patient down to the equivalent of one long-leg standing radiograph. Because of this, it will be more acceptable to obtain the three-dimensional data set produced by CT scanning. Surgeons will be able to document the impact of implant position on outcome with greater precision.

We used computer tomography (CT) to measure the outcome of knee-arthroplasty in our prospective double-blind randomised controlled study of our active constraint robotic system ACROBOT.

All patients in our trial had pre-operative CT scan and proprietary software used to plan the size, position and orientation of the implants. Post operatively a further CT scan was performed and measurement studies performed using 3 different methods of manipulating the CT dicom data.

Method 1, a quick and simple method of implant assessment that measures the varus-valgus orientation of the implants relative to the axes of the long bones

Two landmarks each are used to define the individual mechanical axis for both the femur and tibia, for consistency these landmarks are the very ones used in the planning stage on the pre-operative CT.

Landmarks are then placed on the implants in order to measure their tilt relative to the mechanical axes. An appropriate Hounsfield threshold (2800) was used to image the metal components. The angle between the individual mechanical axis and the prosthetic component was calculated.

Method 2, detailed and accurate comparisons between the planned and achieved component positions in 3D are made. Co-registration of the precisely planned CT based models with surface models from the post-op scan gives real measurements of implant position enabling the measurement of the accuracy of component in an all six degrees of freedom giving both translation and rotation errors in all three planes.

The process of alignment was achieved by surface-to-surface registration. An implementation of the iterative closest point algorithm was used to register matching surfaces on the objects to be registered. A polygon mesh of the implant, provided by the manufacturer, defined the surface shape of each size of implant. This was used both to define the planned position and to register to the post-operative scan. Method 3, in this study we quantified post-operative error in knee arthroplasty using one value for each component whilst retaining 3D perspective.

The position of the prosthetic components in the post-op scan is calculated and individual transformation matrix computed which is matched to the transformation matrices for the planned components.

The pre-operative CT based component positions were co-registered to the post-operative CT scan and values for the intersection (volumetric) between the digitised images (both planned and achieved) were calculated. Both the co-registered femoral and tibial component’s intersection was quantified with software packages supporting Boolean volume analysis

Method 1, the sum of the two, independently measured, angles allows an estimate of the post-operative alignment of the load bearing axes in the two bones.

Method 2, 3D CT allows precise measurements of the achieved position for each component in all three planes. Six values, three angular and three translational, define the achieved component position relative to the planned position.

Method 3, the greater the percentage intersection between the planned and achieved images, the greater the accuracy of the surgery. Owing to the shape of the components (large articular surface) large intersections demonstrate more accurate reconstruction of the joint line.

In the recent past the lack of a sufficiently accurate tool to plan and measure the accuracy of component placement has resulted in an inability to detect and study radiological and functional outliers and hence the hypnotised relationship between prosthetic joint placement and outcome has been difficult to prove.

CT offers us the ability to accurately describe the actual position and deviation from plan of component placement in knee arthroplasty. Whilst X-ray has the intrinsic problems of perspective distortion magnification errors and orientation uncertainties CT can be used to define ‘true’ planes for two dimensional (2D) measurements and permits the comparison in three dimensions (3D) between the planned and achieved component positions.

Accurately planning the intervention and precisely measuring outcome in computer assisted orthopaedic surgery (CAOS) is essential for it permits robust analysis of the efficacy of these systems.

We demonstrate the use of low dose computer tomography (CT) radiation for both the planning and outcome measurement of robotic and conventionally performed knee arthroplasty.

Studies were initially performed on a human phantom pelvis and lower limb. The mAs (milliampere seconds) were varied from 120 to 75 at the pelvis and from 100 to 45 for both the knee and ankle whilst keeping the kV (kilovolt) between 120 and 140. Image quality was evaluated at the different doses.

The volumes scanned were defined on the scout film; they included the whole femoral head (0.5cm above and below the head), 20cm at the knee (10cm on either side of the joint line) and 5cm at the ankle (the distal tibia and the talus). Effective dose (mSv) was calculated using two commercially available software packages. This protocol was subsequently used to image patients in our prospective double-blind randomised controlled study of our active constraint robotic system ACRO-BOT.

With the reduction in the mA and scanned volume the effective dose was reduced to 0.761 mSv in females and 0.497 mSv in males whilst maintaining a sufficient image resolution for our purposes. We found that a mAs of 80 for the hip joint, 100 for the knee and 45 for the ankle was sufficient for imaging in both pre-op planning and pos-operative assessment in knee arthroplasty. This contributed on an average effective dose to the hip of 0.61 mSv, the knee 0.120 mSv and to the ankle 0.0046 mSv.

The results of our study show that we have considerably reduced the effective dose (0.8 mSv) to one third of the Perth Protocol (2.5mSv) by reducing the areas of the body scanned and adjusting the mA for the various parts of the body whist maintaining the x, y and z axis throughout the scan. The areas between the knee, hip and ankle that were not exposed to radiation are not strictly necessary for the planning of knee arthroplasty, but it is essential that the leg does not move during the scanning process. In order to prevent this leg was placed in a radiolucent splint. For post op three dimensional (3D) assessments only the knee component of the protocol is necessary.