Aims. Large-diameter metal-on-metal (MoM) total hip arthroplasty (THA) has demonstrated unexpected high failure rates and pseudotumour formation. The purpose of this prospective cohort study is to report ten-year results in order to establish revision rate, prevalence of pseudotumour formation, and relation with whole blood cobalt levels. Methods. All patients were recalled according to the guidelines of the Dutch Orthopaedic Association. They underwent clinical and radiographical assessments (radiograph and CT scan) of the hip prosthesis and whole blood cobalt ion measurements. Overall, 94 patients (95 hips) fulfilled our requirements for a minimum ten-year follow-up. Results. Mean follow-up was 10.9 years (10 to 12), with a cumulative survival rate of 82.4%. Reason for revision was predominantly pseudotumour formation (68%), apart from loosening, pain, infection, and osteolysis. The prevalence of pseudotumour formation around the prostheses was 41%, while our previous report of this cohort (with a mean follow-up of 3.6 years) revealed a 39% prevalence. The ten-year revision-free survival with pseudotumour was 66.7% and without pseudotumour 92.4% (p < 0.05). There was poor discriminatory ability for cobalt for pseudotumour formation. Conclusion. This prospective study reports a minimum ten-year follow-up of large-head MoM THA. Revision rates are high, with the main reason being the sequelae of pseudotumour formation, which were rarely observed after five years of implantation. Blood ion measurements show limited discriminatory capacity in diagnosing pseudotumour formation. Our results evidence that an early comprehensive follow-up strategy is essential for MoM THA to promptly identify and manage early complications and revise on time. After ten years follow-up, we do not recommend continuing routine CT scanning or whole cobalt blood measurements, but instead enrolling these patients in routine follow-up protocols for THA. Cite this article: Bone Jt Open 2022;3(1):61–67

Summary. Five year migration results of 49 large-head metal-metal (MoM) total hip arthroplasties show good implant stability and no association between implant migration and metal-ions levels, stem and cup position, or femoral bone mineral density. Introduction. The failure mechanism of metal-metal (MoM) total hip arthroplasty has been related to metal wear-debris and pseudotumor, but it is unknown whether implant fixation is affected by metal wear-debris. Patients and Methods. In July-August 2012 41 patients (10 women) at a mean age of 47 (23–63) years with a total of 49 MoM hip arthroplasties (ReCap Shell/M2a-Magnum head/Bi-Metric stem; Biomet Inc.) participated in a 5–7 year follow-up with blood tests (chrome and cobalt serum ions), questionnaires (Oxford Hip Score (OHS) and Harris Hip Score (HHS), measurement of cup and stem position and periprosthetic BMD. Further the patients had been followed with stereo-radiographs post-operative and at 1, 2 and 5 years for analysis of implant migration (Model-Based RSA 3.32). Results. 4 patients (6 hips) had elevated metal-ion levels (>7ug/l). The mean cup inclination was 45°(sd 6), the mean cup anteversion was 17°(sd7), and the mean stem anteversion was 19°(sd7). The difference between genders was statistically insignificant (p>0.09). At 5 years follow-up total translation (TT) for the stems (n=39 hips) was a mean 0.79mm (sd 0.53) and total rotation (TR) was a mean 1.99° (sd 1.53). Between 1–2 years there was no significant difference in mean TT (p=0.49)for the stems and between 2–5 years TT was mean 0.13 mm (sd 0.35) which was significant (p=0.03) but clinically very small and within the precision limits of the method. We found no significant migration along the 3 separate axes. There was no significant association between stem migration and metal ion levels >7ug/l (p=0.55), female gender (p=0.86), stem anteversion > 25° (p=0.29), T-scores < −1 (p=0.23), total OHS < 40 (p=0.19) or total HHS < 90 (p=0.68). Between 1–5 years there was no significant change in neither subsidence (p=0.14) nor in version (p=0.91) of the stems. At 5 years TT for the cups (n=36) was mean 1.21 mm (sd 0.74) and TR was mean 2.63° (sd 1.71). Between 1–2 years cup migration along the z-axis was mean 0.29 (sd 0.73) (p=0.03), which was also within precision limits of the method. There was a positive association between total OHS below 40 (n=4) and cup migration (p=0.04), but no association between cup migration and metal ion levels >7ug/l (p=0.80), female gender (p=0.74), cup inclination > 50° (p=0.93), cup anteversion > 25° (p=0.88) or HHS < 90 (p=0.93). Proximal cup migration at 5 years was mean 0.46 mm (sd 0.47), which was similar to the cup migration at 1 year (p=0.91) and 2 years (p=0.80) follow-up. No patients were revised before the final 5–7 year follow-up. Patient satisfaction was high (94%). Conclusion. All cups and stems were well-fixed between 1–5 years. We found no statistical significant correlation between implant migration and other factors that have been associated with failure of MoM hip arthroplasty such as elevated metal ion levels, component position, and female gender. Cup migration was higher in patients with a total OHS below 40. In conclusion, metal wear-debris does not seem to influence fixation of hip components in large-head MoM articulations at mid-term follow-up

High complication rates and poor outcomes have been widely reported in patients undergoing revision of large head metal-on-metal arthroplasty. A previous study from our centre showed high rates of dislocation, nerve injury, early cup loosening and pseudotumor recurrence. After noting these issues, we implemented the following changes in surgical protocol in all large head MOM revisions: One: Use of highly porous shells in all cases. Two: Use of largest femoral head possible. Three: Low threshold for use of dual mobility and constrained liners when abductors affected or absent posterior capsule. Four: Use of ceramic head with titanium sleeve in all cases. Five: Partial resection of pseudotumor adjacent to sciatic and femoral nerves.

The purpose of the present study is to compare the new surgical protocol above to our previously reported early complications in this group of patients

We specifically looked at (1) complications including reoperations, (2) radiologic outcomes, and (3) functional outcomes. Complication rates after (Group 1), and before (Group 2) modified surgical protocol were compared using Chi-square test, assuming statistical significance p < 0 .05.

Major complications occurred in 4 (8.3%) of 48 patients who had modified surgical technique, compared to 12 (38%) of 32 revisions prior to modification (p < 0 .05). Two hips of 48 (4.17%) endured dislocations in Group 1, compared to 9 of 32 (28%) in Group 2 (p < 0 .05). Four patients of 48 had repeat revision in Group 1: 2 for recurrence of pseudotumor, 1 for dislocation, and 1 for infection, compared to 6 patients who had 7 repeat revisions of 32 patients in Group 2: 3 for acetabular loosening, 3 for dislocation, and 1 for recurrence of pseudotumor (p=0.1). None of 48 revisions in Group 1 had acetabular loosening, compared to 4 of 32 in Group 2 (p=0.02). Two patients had nerve injury in Group 2, compared to none in Group 1 (p=0.16). The mean WOMAC pain score was 87.1 of 100 and the function score was 88.4 of 100 in Group 1, compared to a mean WOMAC pain score of 78 of 100 (p=0.6) and a function score of 83 of 100 in Group 2 (p=0.8).

Modification of the surgical techniques described in the introduction has resulted in a significant decrease in complications in revision of large head MOM total hips. We continue to use this protocol and recommend it for these difficult cases.

Background

High complication rates and poor outcomes have been widely reported in patients undergoing revision of large head metal-on-metal arthroplasty. A previous study from our center showed high rates of dislocation, nerve injury, early cup loosening and pseudotumor recurrence. After noting these issues, we implemented the following changes in surgical protocol in all large head MOM revisions: 1. Use of highly porous shells in all cases 2. Use of largest femoral head possible 3. Low threshold for use of dual mobility and constrained liners when abductors affected or absent posterior capsule 4. Use of ceramic head with titanium sleeve in all cases 5. Partial resection of pseudotumor adjacent to sciatic and femoral nerves.

There has been a significant decline in the use of metal-on-metal (MoM) bearings due to concerns regarding adverse reaction to metal debris (ARMD). The Medicines and Healthcare products Regulatory Agency (MHRA) recommends annual follow-up for life with blood Cobalt (Co) and Chromium (Cr) ion level measurement in all MoM THRs with femoral head size greater than or equal to 36mm. We present the serial ten year serum Co and Cr levels in a cohort of large head MoM THRs and analyse the utility of measuring serum ions levels annually.

All patients who underwent unilateral large head MoM THR between January 2004 and December 2006 were included in this prospective study. Annual serum Co and Cr measurements were measured. Clinical case notes and radiographs were reviewed for failure, revision surgery and the occurrence of ARMD. Mann Whitney test was used to analyse changes in serum Co and Cr levels. Receiver Operating Characteristic (ROC) curve was plotted based on their sensitivity and specificity to detect ARMD.

256 patients were included. There was a significant increase in serum ion values in the first two years. After 7 years, there was no significant change in Co values(p=0.78) and there was a decline in Cr value after 9 years(p<0.001). With 7 µg/l as the cut-off value, the sensitivity and specificity of Co was 82.1% and 65.5% and of Cr was 53.5% and 91.3%.

Annual follow-up of patients with MoM THR based on the MHRA guideline to obtain serum metal ion levels can cost about £9 million/year. Our study noted poor discriminatory ability for both Co and Cr values in the ROC curve. There is poor correlation between serum metal ion levels and the occurrence of ARMD on MARS MRI. Based on our results we find limited utility in doing ion levels after 7 years in asymptomatic patients.

The prevalence of pseudotumours in patients with large-head metal-on-metal (MOM) THA has been the subject of implant recalls and warnings from various regulatory agencies. To date, there is no consensus on whether ultrasound or MRI is superior for the detection and following the progression of pseudotumours. Ultrasound is relatively cheap but can be operator dependent. MARS MRI has the advantage of excellent visibility of the soft tissue. However, MRI comes at a marked increase cost and takes about twice as long to perform. At our institution, we prospectively compared ultrasound to MRI for pseudotumour detection in an asymptomatic cohort of patients with MOM THAs. We enrolled 40 patients with large-head MOM THAs in the study. The mean age was 54 years (range, 34–76 years). The mean time from surgery was 54 months (range, 40–81 months). There were 28 men and 12 women. All patients underwent ultrasound and MRI using slice encoding for metal artifact correction. The gold standard was defined as follows: if both ultrasound and MRI agreed, this was interpreted as concordant and the result was considered accurate. Ultrasound and MRI agreed in 37 of 40 patients (93%). The prevalence of pseudotumours was 31% (12 of 39) in our cohort. Twenty-three of 39 patients (59%) had completely normal tests and four (10%) had simple fluid collections. Ultrasound had a sensitivity of 100% and specificity of 96% while MRI had a sensitivity of 92% and specificity of 100%. Conclusions: A negative ultrasound rules out pseudotumour in asymptomatic patients as this test is 100% sensitive. Given its lower cost, we recommend ultrasound as the initial screening tool for pseudotumours. More recently, Kwon et al have compared ultrasound to MARS MRI for following the progression of pseudotumours. They found a strong agreement between the 2 modalities for assessing change in size and consistency of pseudotumours

The prevalence of pseudotumours in patients with large-head metal-on-metal (MOM) THA has been the subject of implant recalls and warnings from various regulatory agencies. To date, there is no consensus on whether ultrasound or MRI is superior for the detection of pseudotumours. Ultrasound is relatively cheap but can be operator dependent. MARS MRI has the advantage of excellent visibility of the soft tissue. However MRI comes at a marked increase cost and takes about twice as long to perform. At our institution we prospectively compared ultrasound to MRI for pseudotumour detection in an asymptomatic cohort of patients with MOM THAs. Methods. We enrolled 40 patients with large-head MOM THAs in the study. The mean age was 54 years (range, 34–76 years). The mean time from surgery was 54 months (range, 40–81 months). There were 28 men and 12 women. All patients underwent ultrasound and MRI using slice encoding for metal artifact correction. The gold standard was defined as follows: if both ultrasound and MRI agreed, this was interpreted as concordant and the result was considered accurate. Results. Ultrasound and MRI agreed in 37 of 40 patients (93%). The prevalence of pseudotumours was 31% (12 of 39) in our cohort. Twenty-three of 39 patients (59%) had completely normal tests and four (10%) had simple fluid collections. Ultrasound had a sensitivity of 100% and specificity of 96% while MRI had a sensitivity of 92% and specificity of 100%

Background. Previous studies have indicated poor outcomes and high complication rate in patients having revision of metal-on-metal (MoM) hip implants resulting from adverse local tissue reactions. Metal ions released by MoM bearings may potentially increase infection occurrence in patients with failed implants. Questions/purposes. We reviewed all patients at our institution who sustained revision of a failed large-head metal-on-metal hip implant to determine if infection-related complications are associated with the elevation of serum metal ions concentration. Methods. From December 2005 to April 2013, we performed 44 revisions of large-head MoM total hip arthroplasty (THA) and resurfacing in 44 patients. In all revision procedures MoM couplings (ASR XL Acetabular System and DePuy ASR Hip Resurfacing System) were explanted. Preoperative diagnosis were: aseptic loosening in 21 hips, hip pain with high serum metal ions levels in 7 hips, high serum metal ions levels without hip pain in 9 hips, deep infections in 4 hips, unexplained hip pain in 2 hips and periprosthetic fracture in 1 hip. Serum cobalt and chromium analysis were preoperatively conducted in 25 patients. Intraoperative fluid aspiration was performed in all cases to determine the presence or absence of periprosthetic joint infection. Results. Fluid analysis for bacteria reported that 35 of 45 cases were culture negative and 10 of 45 cases (22%) were culture positive to Staphylococcus (St) Aureus (4), St Capitis (2), St Epidermidis (2), St Hominis (1), Streptococcus Mitis (1). All preoperative diagnoses of deep infection were confirmed. Within patients evaluated with serum metal ions analysis (mean Co and Cr, 78 μg/l and 39 μg/l, respectively), five cultures resulted positive (20%). The infection rate within patients with higher (> 20 μg/l) metal ions levels (4 positive cultures of 18, 22%) was not significantly higher than infection rate within patients with lower (≤ 20 μg/l) metal ions levels (1 positive culture of 7, 14%). Conclusions. We observed a high rate of periprosthetic joint infection among our revision cases. High metal ions concentrations released by MoM bearings might promote bacterial infections in patients with MoM THA and resurfacing. When evaluating patients with failed MoM hip devices, there may be an increased incidence of co-infection in these patients

Background. The second generation metal-on-metal (MoM) prosthesis of the hip became a worldwide success in the 90s. However, after the placement of a MoM prosthesis the cobalt ion concentrations raise significantly. This may lead to systemic complaints and even cobalt toxicity. Methods. Sixty-one patients (26F/35M) with both an unilateral and bilateral resurfacing or large-head MoM (LHMoM) hip prosthesis were included. At last follow-up (5.77 ± 1.57 yrs) cobalt concentrations in the blood were determined by ICP-MS. Based on the known cobalt toxicity symptoms we developed a non-validated questionnaire. Analysis was done on two groups; a low cobalt concentration group and a high cobalt concentration group. We used 170 nmol/L as the upper limit of well functioning prosthesis as defined by the Dutch Orthopaedic Society (NOV). Independent samples T test and Pearson correlation coefficient were done. Results. In 61 patients, 70 prosthesis were implanted: 44 resurfacings and 26 LHMoM. Mean cobalt and chromium ion concentrations were 110 ± 138 (9 – 833) and 104 ± 138 (6 – 592) nmol/L. The low cobalt concentration group consisted of 52 patients, while the high cobalt concentration group consisted of 9 hips. With respect to the systemic complaints, the subjects in the high or low group reported no significant differences. A trend towards more complaints with visual problems (75% vs 51.9%, P = .089) and dizziness (62.5% vs 38.9%, P = .098) was notable in the high cobalt concentration group. Conclusions. Metal on metal hip arthroplasty stays controversial for the possible side-effects. This study shows trends, but no significance, in systemic complaints from high cobalt ion concentrations. Complaints of neuro-ocular toxicity are most common. This is in correspondence with other literature, although the upper limit for cobalt ion concentrations remains uncertain. Level of Evidence. 2b. Disclosure. no financial or nonfinancial relationships to disclose

Objectives

To quantify and compare peri-acetabular bone mineral density (BMD) between a monoblock acetabular component using a metal-on-metal (MoM) bearing and a modular titanium shell with a polyethylene (PE) insert. The secondary outcome was to measure patient-reported clinical function.

The October 2014 Hip & Pelvis Roundup³⁶⁰ looks at: functional acetabular orientation; predicting re-admission following THR; metal ions and resurfacing; lipped liners increase stability; all anaesthetics equal in hip fracture surgery; revision hip surgery in very young patients; and uncemented hips.

Total knee arthroplasty (TKA) is an established and successful procedure. However, the design of prostheses continues to be modified in an attempt to optimise the functional outcome of the patient.

The aim of this study was to determine if patient outcome after TKA was influenced by the design of the prosthesis used.

A total of 212 patients (mean age 69; 43 to 92; 131 female (62%), 81 male (32%)) were enrolled in a single centre double-blind trial and randomised to receive either a Kinemax (group 1) or a Triathlon (group 2) TKA.

Patients were assessed pre-operatively, at six weeks, six months, one year and three years after surgery. The outcome assessments used were the Oxford Knee Score; range of movement; pain numerical rating scales; lower limb power output; timed functional assessment battery and a satisfaction survey. Data were assessed incorporating change over all assessment time points, using repeated measures analysis of variance longitudinal mixed models. Implant group 2 showed a significantly greater range of movement (p = 0.009), greater lower limb power output (p = 0.026) and reduced report of ‘worst daily pain’ (p = 0.003) over the three years of follow-up. Differences in Oxford Knee Score (p = 0.09), report of ‘average daily pain’ (p = 0.57) and timed functional performance tasks (p = 0.23) did not reach statistical significance. Satisfaction with outcome was significantly better in group 2 (p = 0.001).

These results suggest that patient outcome after TKA can be influenced by the prosthesis used.

Cite this article: Bone Joint J 2015;97-B:64–70.

Hip replacement is a very successful operation and the outcome is usually excellent. There are recognised complications that seem increasingly to give rise to litigation. This paper briefly examines some common scenarios where litigation may be pursued against hip surgeons. With appropriate record keeping, consenting and surgical care, the claim can be successfully defended if not avoided. We hope this short summary will help to highlight some common pitfalls. There is extensive literature available for detailed study.

Objectives

An ongoing prospective study to investigate failing metal-on-metal hip prostheses was commenced at our centre in 2008. We report on the results of the analysis of the first consecutive 126 failed mated total hip prostheses from a single manufacturer.