Large-head metal-on-metal total hip replacement has a failure rate of almost 8% at five years, three times the revision rate of conventional hip replacement. Unexplained pain remains a feature of this type of arthroplasty. All designs of the femoral component of large-head metal-on-metal total hip replacements share a unique characteristic: a subtended angle of 120° defining the proportion of a sphere that the head represents. Using MRI, we measured the contact area of the iliopsoas tendon on the femoral head in sagittal reconstruction of 20 hips of patients with symptomatic femoroacetabular impingement. We also measured the articular extent of the femoral head on 40 normal hips and ten with cam-type deformities. Finally, we performed virtual hip resurfacing on normal and cam-type hips, avoiding overhang of the metal rim inferomedially. The articular surface of the femoral head has a subtended angle of 120° anteriorly and posteriorly, but only 100° medially. Virtual surgery in a normally shaped femoral head showed a 20° skirt of metal protruding medially where iliopsoas articulates. The excessive extent of the large-diameter femoral components may cause iliopsoas impingement independently of the acetabular component. This may be the cause of postoperative pain with these implants

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

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.

Peri-articular soft-tissue masses or ‘pseudotumours’ can occur after large-diameter metal-on-metal (MoM) resurfacing of the hip and conventional total hip replacement (THR). Our aim was to assess the incidence of pseudotumour formation and to identify risk factors for their formation in a prospective cohort study.

A total of 119 patients who underwent 120 MoM THRs with large-diameter femoral heads between January 2005 and November 2007 were included in the study. Outcome scores, serum metal ion levels, radiographs and CT scans were obtained. Patients with symptoms or an identified pseudotumour were offered MRI and an ultrasound-guided biopsy.

There were 108 patients (109 hips) eligible for evaluation by CT scan at a mean follow-up of 3.6 years (2.5 to 4.5); 42 patients (39%) were diagnosed with a pseudotumour. The hips of 13 patients (12%) were revised to a polyethylene acetabular component with small-diameter metal head. Patients with elevated serum metal ion levels had a four times increased risk of developing a pseudotumour.

This study shows a substantially higher incidence of pseudotumour formation and subsequent revisions in patients with MoM THRs than previously reported. Because most revision cases were identified only after an intensive screening protocol, we recommend close monitoring of patients with MoM THR.

Large-head metal-on-metal (MoM) total hip replacements (THR) have given rise to concern. Comparative studies of small-head MoM THRs over a longer follow-up period are lacking. Our objective was to compare the incidence of complications such as infection, dislocation, revision, adverse local tissue reactions, mortality and radiological and clinical outcomes in small-head (28 mm) MoM and ceramic-on-polyethylene (CoP) THRs up to 12 years post-operatively. A prospective cohort study included 3341 THRs in 2714 patients. The mean age was 69.1 years (range 24 to 98) and 1848 (55.3%) were performed in women, with a mean follow-up of 115 months (18 to 201). There were 883 MoM and 2458 CoP bearings. Crude incidence rates (cases/1000 person-years) were: infection 1.3 vs 0.8; dislocation 3.3 vs 3.1 and all-cause revision 4.3 vs 2.2, respectively. There was a significantly higher revision rate after ten years (adjusted hazard ratio 9.4; 95% CI 2.6 to 33.6) in the MoM group, and ten of 26 patients presented with an adverse local tissue reaction at revision. No differences in mortality, osteolysis or clinical outcome were seen. In conclusion, we found similar results for small-head MoM and CoP bearings up to ten years post-operatively, but after ten years MoM THRs had a higher risk of all-cause revision. Furthermore, the presence of an adverse response to metal debris seen in the small-head MOM group at revision is a cause for concern. Cite this article: Bone Joint J 2014; 96-B:868–75

Aims

The present study investigated the five-year interval changes in pseudotumours and measured serum metal ions at long-term follow-up of a previous report of 28 mm diameter metal-on-metal (MoM) total hip arthroplasty (THA).

We investigated the incidence of soft-tissue lesions after small head metal-on-metal total hip replacement (MoM THR). Between December 1993 and May 1999, 149 patients (195 hips) underwent primary cementless MoM THR.

During the follow-up period, three patients (five THRs) died and eight patients (14 THRs) were lost to follow-up. We requested that all patients undergo CT evaluation. After exclusion of five patients (six THRs) who had undergone a revision procedure, and 22 (28 THRs) who were unwilling to take part in this study, 111 patients (142 THRs) were evaluated. There were 63 men (88 THRs) and 48 women (54 THRs) with a mean age of 45.7 years (37 to 56) at the time of surgery. The mean follow-up was 15.4 years (13 to 19). A soft-tissue lesion was defined as an abnormal peri-prosthetic collection of fluid, solid lesion or asymmetrical soft-tissue mass.

At final follow-up, soft-tissue lesions were found in relation to 28 THRs (19.7%), including 25 solid and three cystic lesions. They were found in 20 men and eight women; 26 lesions were asymptomatic and two were symptomatic. The mean maximal diameter of the soft-tissue lesion was 42.3 mm (17 to 135). The relatively high rate of soft-tissue lesions observed with small head MoM THR remains a concern.

Cite this article: Bone Joint J 2014;96-B:1594–9.

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.

Lately, concerns have arisen following the use of large metal-on-metal bearings in hip replacements owing to reports of catastrophic soft-tissue reactions resulting in implant failure and associated complications. This review examines the literature and contemporary presentations on current clinical dilemmas in metal-on-metal hip replacement.

This study reports the mid-term results of a large-bearing hybrid metal-on-metal total hip replacement in 199 hips (185 patients) with a mean follow-up of 62 months (32 to 83).

Two patients died of unrelated causes and 13 were lost to follow-up. In all, 17 hips (8.5%) have undergone revision, and a further 14 are awaiting surgery. All revisions were symptomatic. Of the revision cases, 14 hips showed evidence of adverse reactions to metal debris. The patients revised or awaiting revision had significantly higher whole blood cobalt ion levels (p = 0.001), but no significant difference in acetabular component size or position compared with the unrevised patients. Wear analysis (n = 5) showed increased wear at the trunnion-head interface, normal levels of wear at the articulating surfaces and evidence of corrosion on the surface of the stem.

The cumulative survival rate, with revision for any reason, was 92.4% (95% confidence interval 87.4 to 95.4) at five years. Including those awaiting surgery, the revision rate would be 15.1% with a cumulative survival at five years of 89.6% (95% confidence interval 83.9 to 93.4).

This hybrid metal-on-metal total hip replacement series has shown an unacceptably high rate of failure, with evidence of high wear at the trunnion-head interface and passive corrosion of the stem surface. This raises concerns about the use of large heads on conventional 12/14 tapers.

The issues surrounding raised levels of metal ions in the blood following large head metal-on-metal total hip replacement (THR), such as cobalt and chromium, have been well documented. Despite the national popularity of uncemented metal-on-polyethylene (MoP) THR using a large-diameter femoral head, few papers have reported the levels of metal ions in the blood following this combination. Following an isolated failure of a 44 mm Trident–Accolade uncemented THR associated with severe wear between the femoral head and the trunnion in the presence of markedly elevated levels of cobalt ions in the blood, we investigated the relationship between modular femoral head diameter and the levels of cobalt and chromium ions in the blood following this THR.

A total of 69 patients received an uncemented Trident–Accolade MoP THR in 2009. Of these, 43 patients (23 men and 20 women, mean age 67.0 years) were recruited and had levels of cobalt and chromium ions in the blood measured between May and June 2012. The patients were then divided into three groups according to the diameter of the femoral head used: 12 patients in the 28 mm group (controls), 18 patients in the 36 mm group and 13 patients in the 40 mm group. A total of four patients had identical bilateral prostheses in situ at phlebotomy: one each in the 28 mm and 36 mm groups and two in the 40 mm group.

There was a significant increase in the mean levels of cobalt ions in the blood in those with a 36 mm diameter femoral head compared with those with a 28 mm diameter head (p = 0.013). The levels of cobalt ions in the blood were raised in those with a 40 mm diameter head but there was no statistically significant difference between this group and the control group (p = 0.152). The levels of chromium ions in the blood were normal in all patients.

The clinical significance of this finding is unclear, but we have stopped using femoral heads with a diameter of ≤ 36 mm, and await further larger studies to clarify whether, for instance, this issue particularly affects this combination of components.

Cite this article: Bone Joint J 2014;96-B:43–7.

Plasma levels of cobalt and chromium ions and Metal Artefact Reduction Sequence (MARS)-MRI scans were performed on patients with 209 consecutive, unilateral, symptomatic metal-on-metal (MoM) hip arthroplasties. There was wide variation in plasma cobalt and chromium levels, and MARS-MRI scans were positive for adverse reaction to metal debris (ARMD) in 84 hips (40%). There was a significant difference in the median plasma cobalt and chromium levels between those with positive and negative MARS-MRI scans (p < 0.001). Compared with MARS-MRI as the potential reference standard for the diagnosis of ARMD, the sensitivity of metal ion analysis for cobalt or chromium with a cut-off of > 7 µg/l was 57%. The specificity was 65%, positive predictive value was 52% and the negative predictive value was 69% in symptomatic patients. A lowered threshold of > 3.5 µg/l for cobalt and chromium ion levels improved the sensitivity and negative predictive value to 86% and 74% but at the expense of specificity (27%) and positive predictive value (44%).

Metal ion analysis is not recommended as a sole indirect screening test in the surveillance of symptomatic patients with a MoM arthroplasty. The investigating clinicians should have a low threshold for obtaining cross-sectional imaging in these patients, even in the presence of low plasma metal ion levels.

Dislocation remains among the most common complications of, and reasons for, revision of both primary and revision total hip replacements (THR). Hence, there is great interest in maximising stability to prevent this complication. Head size has been recognised to have a strong influence on the risk of dislocation post-operatively. As femoral head size increases, stability is augmented, secondary to an increase in impingement-free range of movement. Larger head sizes also greatly increase the ‘jump distance’ required for the head to dislocate in an appropriately positioned cup. Level-one studies support the use of larger diameter heads as they decrease the risk of dislocation following primary and revision THR. Highly cross-linked polyethylene has allowed us to increase femoral head size, without a marked increase in wear. However, the thin polyethylene liners necessary to accommodate larger heads may increase the risk of liner fracture and larger heads have also been implicated in causing soft-tissue impingement resulting in groin pain. Larger diameter heads also impart larger forces on the femoral trunnion, which may contribute to corrosion, metal release, and adverse local tissue reactions. Alternative large bearings including large ceramic heads and dual mobility bearings may mitigate some of these risks, and several of these devices have been used with clinical success.

Cite this article: Bone Joint J 2014;96-B(11 Suppl A):23–6.

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.

We undertook a randomised controlled trial to compare bipolar hemiarthroplasty (HA) with a novel total hip replacement (THR) comprising a polycarbonate–urethane (PCU) acetabular component coupled with a large-diameter metal femoral head for the treatment of displaced fractures of the femoral neck in elderly patients. Functional outcome, assessed with the Harris hip score (HHS) at three months and then annually after surgery, was the primary endpoint. Rates of revision and complication were secondary endpoints.

Based on a power analysis, 96 consecutive patients aged > 70 years were randomised to receive either HA (49) or a PCU-THR (47). The mean follow-up was 30.1 months (23 to 50) and 28.6 months (22 to 52) for the HA and the PCU group, respectively.

The HHS showed no statistically significant difference between the groups at every follow-up. Higher pain was recorded in the PCU group at one and two years’ follow-up (p = 0.006 and p = 0.019, respectively). In the HA group no revision was performed. In the PCU-THR group six patients underwent revision and one patient is currently awaiting re-operation. The three-year survival rate of the PCU-THR group was 0.841 (95% confidence interval 0.680 to 0.926).

Based on our findings we do not recommend the use of the PCU acetabular component as part of the treatment of patients with fractures of the femoral neck.

Cite this article: Bone Joint J 2013;95-B:609–15.

Noise generation has been reported with ceramic-on-ceramic articulations in total hip replacement (THR). This study evaluated 208 consecutive Delta Motion THRs at a mean follow-up of 21 months (12 to 35). There were 141 women and 67 men with a mean age of 59 years (22 to 84). Patients were reviewed clinically and radiologically, and the incidence of noise was determined using a newly described assessment method. Noise production was examined against range of movement, ligamentous laxity, patient-reported outcome scores, activity level and orientation of the acetabular component. There were 143 silent hips (69%), 22 (11%) with noises other than squeaking, 17 (8%) with unreproducible squeaking and 26 (13%) with reproducible squeaking. Hips with reproducible squeaking had a greater mean range of movement (p < 0.001) and mean ligament laxity (p = 0.004), smaller median head size (p = 0.01) and decreased mean acetabular component inclination (p = 0.02) and anteversion angle (p = 0.02) compared with the other groups. There was no relationship between squeaking and age (p = 0.13), height (p = 0.263), weight (p = 0.333), body mass index (p = 0.643), gender (p = 0.07) or patient outcome score (p = 0.422). There were no revisions during follow-up. Despite the surprisingly high incidence of squeaking, all patients remain satisfied with their hip replacement.

Cite this article: Bone Joint J 2013;95-B:160–5.

We report a case of a male patient presenting with bilateral painful but apparently well-positioned and -fixed large-diameter metal-on-metal hip replacements four years post-operatively. Multiple imaging modes revealed a thick-walled, cystic expansile mass in communication with the hip joint (a pseudotumour). Implant retrieval analysis and tissue culture eliminated high bearing wear or infection as causes for the soft-tissue reaction, but noted marked corrosion of the modular neck taper adaptor and corrosion products in the tissues. Therefore, we believe corrosion products from the taper caused by mismatch of the implant components led to pseudotumour formation requiring revision.

Persistent groin pain after seemingly successful total hip replacement (THR) appears to have become more common. Recent studies have indicated a high incidence after metal-on-polyethylene and metal-on-metal conventional THR and it has been documented in up to 18% of patients after metal-on-metal resurfacing. There are many causes, including acetabular loosening, stress fracture, and iliopsoas tendonitis and impingement. The evaluation of this problem requires a careful history and examination, plain radiographs and an algorithmic approach to special diagnostic imaging and tests. Non-operative treatment is not usually successful. Specific operative treatment depending on the cause of the pain usually involves revision of the acetabular component, iliopsoas tenotomy or other procedures, and is usually successful. Here, an appropriate algorithm is described.

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.