This study utilized data from the NJR dataset on all Corail/Pinnacle total hip replacements (THR) to determine (a) the level of unit variation of the Corail/Pinnacle 36mm Metal On Metal THR within England and Wales; (b) patient, implant and surgeon factors that may be associated with higher revision rates; (c) Account for the influence of the MHRA announcement in 2010.

The national Revision Rate (RR) for the Corail / Pinnacle MOM THR was 10.77% (OR:1.46; CI:1.17–1.81). This was significantly greater than other articulation combinations (MOP 1.72%, COP 1.36%, COC 2.19%).

The 2010 MHRA announcement did not increase rate of revision (X²=1649.63, df=13, p<.001).

Patient factors associated with significantly increased revision rates included, female gender (OR 1.38 (CI 1.17–1.63, p<.001) and younger age OR 0.99 (CI 0.98–0.99), p<.001). Implant factor analysis demonstrated an inverse relationship between cup size and revision. As head length increased RR increased – highest risk of revision +12.5 (OR 1.69 (CI 1.12–2.55), p=0.13). Coxa vara, high offset stems had a higher risk of revision compared to standard offset stems (OR:1.41 (CI 1.15–1.74; p<.001). As stem size increased risk of revision decreased (OR 0.89 (CI 0.85–0.93); p<.001). Surgeon grade did not influence RR.

There was significant variation in RR between hospitals with 7 units (7/61 excluding low volume centres, <50 implants) identified as having significant higher rates of revision. However, for each of these units there was a greater proportion of higher risk patients (female, cup size 50–54, stem type).

This study has provided insight into unit variation, risk factors and the long term outcome of the Corail/Pinnacle 36mm MOMTHR. Future aims are to use these results to develop a risk stratified algorithm for the long term follow of these patients to minimize patient inconvenience and excess use of limited NHS resources.

Using a femoral head from one manufacturer on the stem of another manufacturer poses the risk that the taper interface between the components do not contact correctly and the performance of the joint will be impaired. The cohorts in this study are a combination of modular Birmingham Hip Resurfacing (BHR) and Adept femoral heads on CPT stems. The study reviews the geometry of the taper interfaces to establish if the taper clearance angles was outside of the normal range for other taper interfaces. In addition the rates of material loss from the bearings and taper and a ranking of the stem damage were reviewed to determine if the levels of loss were above that seen for other similar joints.

The material loss analysis demonstrated that the rates or levels of loss from the bearings, taper and stem are no different to levels published for manufacturer matched joints and in many cases are lower. The results demonstrate that the taper clearance angles for the mixed manufacturer joints (BHR-CPT: 0.067 to −0.116, Adept-CPT: 0.101 to −0.056) were within the range of other studies and manufacturer matched clearances (0.134 to −0.149).

Using components from different manufacturers has not in this instance increased the level of material loss from the joints, when compared to other similar manufacturer matched joints.

This study reports the mid-term results of a large bearing uncemented metal on metal total hip replacement (MOMHTHR) matched series using the Synergy stem and Birmingham modular head in 36 hips (mean follow up 61 months). All patients underwent clinical, metal ion and MRI assessment. Wear analysis was performed on retrieved heads using Redlux non-contact optical profilometry.

Seven patients (19%) have undergone revision surgery. All revisions had two or more of either symptoms, high metal ions or an MRI suggestive of an adverse reaction to metal debris (ARMD). There was no evidence of component malposition or impingement. Frank staining of tissues together with high volume dark brown fluid collections were found in all cases. All stems and cups were well fixed. In 4 cases pubic and ischial lysis (adjacent to the inferior fins) was observed. All 7 cases had radiological, intraoperative and histological evidence of ARMD (Figure 1). The failure cohort had significantly higher whole blood cobalt ion levels and OHS (p = 0.001), but no significant difference in cup size (p = 0.77), gender predominance, stem offset or cup position (p = 0.12). Sleeves had been used in all revision cases

Wear analysis (n = 4) demonstrated increased wear at the trunnion/sleeve interface in a distribution compatible with micromotion (Figure 2). There was normal wear at the articulating surface.

This series further demonstrates unacceptable failure rates in LHMOMTHR in a series where a compatible stem for the BHR modular head was used. Use of a CoCr sleeve within a CoCr head taper appears to contribute to abnormal wear and therefore potential ARMD and subsequent failure.

Introduction

Metal on metal hip arthroplasty continues to be controversial. Emerging evidence suggests that there are multiple modes of failure, and that the results of revision surgery are influenced by host and implant factors.

Background

Large diameter chrome cobalt modular heads in hip replacement surgery have caused one of the biggest challenges to face orthopaedic surgeons, manufacturers and regulators in a generation. Increasing numbers of retrieved implants offer the opportunity to look in detail at the modes of failure of these devices.

Introduction:

High failure rates with large diameter, metal on metal hip replacements have highlighted a potential issue with the head/stem taper junction as one of the significant sources of metal ion release. Postulated reasons as to why this may be such a problem with large head metal on metal hip replacements is due to the increased torque achieved by the larger head size. This may be responsible for applying greater micromotion between the head and stem taper and consequently greater amounts of fretting corrosion. The aim of this study was to perform short term in vitro electrochemical tests to assess the effect of increasing head diameter and torque on the fretting corrosion susceptibility of the head/stem taper interface and to investigate its effect on different material combinations.

Introduction:

Cemented femoral components have been used in hip replacement surgery since its inception. For many patients this works well, but recent retrieval studies^1–4 and more fundamental studies^{5, 6} have highlighted the issues of damage and material loss from the both matt and polished cemented stems.

The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal articulating surface wear has focussed attention on the trunnion / taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in form and surface finish of the head taper as well as quantitative assessment of wear volume. This study aimed to assess and compare qualitatively tapers from small and large diameter MOMTHR's. Tapers from 3 retrieval groups were analysed. Group 1: 28mm CoCr heads from MOMTHRs (n=5); Group 2: Large diameter CoCr heads from LHMOMTHRs (n=5); Gp 3 (control): 28mm heads from metal on polyethylene (MOP) THRs; n=3). Clinical data on the retrievals was collated. RedLux profiling of tapers produced a taper angle and 3D surface maps. The taper angles were compared to those obtained using CMM measurements. There was no difference between groups in mean 12/14 taper angles or bearing surface volumetric and linear wear. Only LHMOMs showed transfer of pattern from stem trunnion to head taper, with clear demarcation of contact and damaged areas.3D surface mapping demonstrated wear patterns compatible with motion or deformations between taper and trunnion in the LHMOM group. These appearances were not seen in tapers from small diameter MOM and MOP THRs. Differences in appearance of the taper surface between poorly functioning LHMOMTHRs and well functioning MOP or MOM small diameter devices highlight an area of concern and potential contributor to the mode of early failure.

The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal wear at the articulating surfaces has focussed attention on the trunnion / taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in the form and surface finish of the head taper as well as a quantitative assessment of wear volume. This study aimed to assess and compare qualitatively the tapers from well functioning small diameter, with poorly functioning LHMOMTHR's using the above technique.

Pseudotumour formation is being reported with increasing frequency in failing metal-on-metal hip resurfacings and replacements. This mode of failure complication has also been reported with metal-on-polyethylene bearing bearings when it is usually associated with evidence of surface corrosion and no apparent wear at the head–neck taper.

We present a case with evidence of taper wear and damage secondary to corrosion in an uncemented total hip replacement with a metal on polyethylene articulation (TMZF (Titanium, Molybdenum, Zirconium and Ferrous) Accolade® stem, Trident® HA coated acetabular shell, Low Friction Ion Treatment (LFIT™) Cobalt-Chrome anatomic head (40 mm), X3® polyethylene liner)

The aim of this study was to perform a comprehensive evaluation of the changes in function from pre- to post-surgery in total and unilateral knee arthroplasty (UKA/TKA) patients. Twenty healthy (age 62.4 ±5.9, 11 male), 14 UKA (age 60.9 ±10.1, 8 male) and 17 TKA (age 67.2 ±8.1, 9 male) patients were studied. KA patients were assessed four weeks pre- and six months post-operation. Measures of perceived pain and function were collected using Oxford Knee Score (OKS) questionnaire. Tests of objective function included joint range of motion (RoM), ultrasound imaging, and 3-D motion analysis/inverse modelling from gait and sit-stand. An optimal set of variables was used to classify KA function using the Cardiff DST method. Pre-KA and healthy individuals were accurately classified (96%). Post-operation questionnaire measures of function improved for both UKA and TKA groups. However, observed measures of RoM, muscle atrophy and gait had only limited gains. This resulted in 57% of UKA and only 27% of TKA patients being classified as healthy post-operation. The results of this study show that 6 months post-surgery UKA patients had higher function than TKA. Using statistical approaches to combine functional assessments has provided an accurate platform to classify function and estimate changes from pre- to post-surgery. The clinical application of this tool requires further investigation and comparison to commonly used clinical techniques.

The poor outcome of large head metal on metal total hip replacements (LHMOMTHR) in the absence of abnormal wear at the articulating surfaces has focussed attention on the trunnion/taper interface. The RedLux ultra-precision 3D form profiler provides a novel indirect optical method to detect small changes in form and surface finish of the head taper as well as a quantitative assessment of wear volume. This study aimed to assess and compare qualitatively the tapers from small diameter with LHMOMTHR's. 3 groups of retrieval tapers were analysed (Group 1: 28mm CoCr heads from MOMTHRs (n=5); Group 2: Large diameter CoCr heads from LHMOMTHRs (n=5); Group 3: 28mm heads from metal on polyethylene (MOP) THRs; n=3). Clinical data on the retrievals was collated. Both bearing surfaces and head tapers were measured for wear using the Redlux profiling non contact measurement system. Measurements included taper angle and 3D surface maps. Taper angles obtained with the Redlux method were compared to those obtained using CMM measurement on 3 parts. The Redlux profiling, including imprints, was also repeated 3 times to gauge potential errors. There was no difference in mean 12/14 taper angles between groups. There was no difference in volumetric and linear wear at the bearing surface between groups. Only the LHMOMs showed transfer of pattern from the stem to the internal head taper, with clear demarcation of the contact and damaged area between head taper and stem trunnion. 3D surface mapping demonstrated wear patterns compatible with motion or deformations between taper and trunnion in the LHMOM group alone. Discussion: Differences in appearance of the taper surface between LHMOMTHRs and MOP or MOM small diameter devices highlight an area of concern and potential contributor to the mode of early failure. Further work is required to fully qualify the Redlux method capabilities.

This study reports the mid-term results of a large bearing hybrid metal on metal total hip replacement (MOMHTHR) in 199 hips (185 patients) with mean follow up of 62 months. Clinical, radiological, metal ion and retrieval analysis were performed.

Seventeen patients (8.6%) had undergone revision, and a further fourteen are awaiting surgery (defined in combination as failures). Twenty one (68%) failures were females. All revisions and ten (71%) awaiting revision were symptomatic. Twenty four failures (86%) showed progressive radiological changes.

Fourteen revision cases showed evidence of adverse reactions to metal debris (ARMD). The failure cohort had significantly higher whole blood cobalt ion levels (p=0.001), but no significant difference in cup size (p=0.77), inclination (p=0.38) or cup version (p=0.12) compared to the non revised cohort. Female gender was associated with increased risk of failure (p=0.04). Multifactorial analysis demonstrated isolated raised Co levels in the absence of symptoms or XR changes were not predictive of failure (p=0.675). However the presence of pain (p<0.001) and XR changes (p<0.001) in isolation were significant predictors of failure. Wear analysis (n=5) demonstrated increased wear at the trunnion/head interface (mean out of roundness measurements 34.5 microns (normal range 8–10 microns) with normal wear levels at the articulating surfaces. Macroscopically corrosion was evident at the proximal and distal stem surfaces. Cumulative survival rate, with revision for any reason was 92.4% (95%CI: 87.4–95.4) at 5 years. Including those awaiting surgery, the revision rate would be 15.1% with 89.6% (95% CI: 83.9–93.4). Cumulative survival at 5 years.

This MOMHTHR series has demonstrated unacceptable high failure rates with evidence of high wear at the head/trunnion interface and passive corrosion to the stem surface. Female gender was an independent risk factor of failure. Metal ion levels remain a useful aspect of the investigation work up but in isolation are not predictive of failure.

This study utilised NJR primary hip data from the 6^th Annual Report to determine the rate and indication for revision between cemented, uncemented, hybrid and resurfacing prosthetic groups. Regression analysis was performed to identify the influence of gender and ASA grade on these revision rates. Validity of the data was interrogated by exploring for episodes of misclassification.

Background

Since 1991 to 2008 approximately 800,000 Exeter stems have been sold worldwide with 80 reported cases of fracture (neck or stem). This study aimed to determine factors predisposing to fracture.

This study reports the mid-term results of a large bearing hybrid metal on metal total hip replacement (MOMHTHR) in 199 hips (185 patients) with mean follow up of 62 months. Clinical, radiological outcome, metal ion levels and retrieval analysis were performed.

Seventeen patients (8.6%) had undergone revision, and a further fourteen are awaiting surgery (defined in combination as failures). Twenty one (68%) failures were females. All revisions and ten (71%) of those awaiting revision were symptomatic. Twenty four failures (86%) showed progressive radiological changes.

Fourteen revision cases showed evidence of adverse reactions to metal debris (ARMD). The failure cohort had significantly higher whole blood cobalt ion levels (p=0.001), but no significant difference in cup size (p=0.77), inclination (p=0.38) or cup version (p=0.12) in comparison to the non revised cohort. Female gender was associated with an increased risk of failure (chi squared p=0.04). Multifactorial analysis demonstrated isolated raised Co levels in the absence of either symptoms or XR changes was not predictive of failure (p=0.675). However both the presence of pain (p<0.001) and XR changes (p<0.001) in isolation were both significant predictors of failure. Wear analysis (n=5) demonstrated increased wear at the trunnion/head interface (mean out of roundness measurements of 34.5 microns +/−13.3 (+/−2SD, normal range 8-10 microns) with normal levels of wear at the articulating surfaces. There was evidence of corrosion at the proximal and distal stem surfaces. The cumulative survival rate, with revision for any reason was 92.4% (95%CI: 87.4-95.4) at 5 years. Including those awaiting surgery, the revision rate would be 15.1% with cumulative survival at 5 years of 89.6% (95% CI: 83.9-93.4).

This MOMHTHR series has demonstrated unacceptable high failure rates with evidence of high wear at the head/trunnion interface and passive corrosion to the stem surface. This raises concern with the use of large heads on conventional 12/14 tapers. Female gender was an independent risk factor of failure. Metal ion levels remain a useful aspect of the investigation work up but in isolation are not predictive of failure.

Objective

To determine the use of oral anti-inflammatory drugs use in the year before and the two years after primary total hip (THR) or knee (TKR) replacement, and to assess whether this varied according to the Body mass Index (BMI).

Introduction and aim

One of the suggested advantages of hip resurfacing arthroplasty is that it offers the possibility of straightforward revision. As the femoral canal is not violated during the resurfacing procedure, it is postulated that the outcome of revision surgery should be equivalent to that of a primary hip arthroplasty. The purpose of this study was to investigate whether revision was as straightforward and as successful as has been suggested.

Introduction: Functional Foot Orthoses (FFO’s) have been shown to improve one element of balance, postural sway, when prescribed for patients with ankle injuries. Little is known, however, about the effect of these devices on ankle stability/proprioception, or the changes which might occur as the patient becomes habituated to using the device. We studied these effects from the time of initial application of the FFO through to regular usage at six weeks.

Methods: Patients with musculoskeletal conditions affecting the lower limb that required custom made FFO’s were evaluated. A standardised protocol, using the Biodex stability system (a balance platform), to assess several stability indices was performed. Patients were assessed before fitting the orthosis, at the time of fitting and six weeks later. The American Orthopaedic Foot and ankle Society (AOFAS) score was also used to evaluate the progress of these patients.

Results: There were 13 male and seven female patients, aged 10 to 64 years. Patients had a range of orthopaedic conditions and all been assessed by orthopaedic specialist and podiatrist as having correctable foot biomechanics. In 6 patients, proprioception deteriorated on initial application of FFO’s. However, all patients exhibited improved over-all stability by a mean of 2.5 points (Normal range 0.82–3.35) at 6 weeks evaluation. The mean AOFAS on presentation was 72 and the final mean score was 97, both of which were clinically and statistically significant (t test, p< 0.05). Eighteen patients had complete resolution of symptoms of pain and instability.

Conclusions: FFO’s alter foot biomechanics, and in doing so appear also to improve balance and proprioception. Proprioception deteriorated in 30% of cases on initial application of orthotics, but pain and instability improved in more than 90% of patients on extended use of foot orthotics, with this improvement becoming manifest by 6 weeks after starting use of the device.

Introduction: One of the main factors in the success of impaction bone grafting (IBG) in revision hip surgery is its ability to resist shear and to form a stable construct. Bone marrow contains multipotent skeletal stem cells and we propose that in combination with allograft will produce a living composite with biological and mechanical potential. In this study we looked at whether coating of the allograft with type 1 collagen followed by seeding with human bone marrow stromal cells (hBMSC) would enhance the grafts mechanical and biological properties.

Methods: A control group of plain allograft and three experimental groups where used to determine the effects that collagen and hBMSC have on IBG. The samples where impacted in standardised fashion previously validated to replicate femoral IBG, and cultured in vitro for 2 weeks. The samples then underwent mechanical shear testing and biochemical analysis for DNA content and Osteogenic activity.

Results: Collagen coating of the allograft prior to seeding with hBMSC significantly enhanced the mechanical properties of the construct compared to the ‘gold standard’ of plain allograft with a 22% increase in shear strength (p=0.002). The collagen coated group also showed increased osteogenic differentiation of the stromal cells (Alkaline Phospatase specific activity: 124 +/− 18.6 vs 54.6 +/− 9.6 nM pNPP/Hr/ngDNA p= < 0.01).

Discussion: This study has shown a role in the improvement of the biomechanical properties of IBG by coating with collagen and seeding with hBMSC. Collagen coating of IBG is a simple process and translation of the technique into the theatre setting feasible. The improvement in shear strength and cohesion could lead to earlier weight bearing for the patients and allow quicker recovery. The therapeutic implications of such composites auger well for orthopaedic applications. We are currently strengthening the above findings with an in vivo study.