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The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1597 - 1603
1 Dec 2016
Meermans G Doorn JV Kats J

Aims

One goal of total hip arthroplasty is to restore normal hip anatomy. The aim of this study was to compare displacement of the centre of rotation (COR) using a standard reaming technique with a technique in which the acetabulum was reamed immediately peripherally and referenced off the rim.

Patients and Methods

In the first cohort the acetabulum was reamed to the floor followed by sequentially larger reamers. In the second cohort the acetabulum was only reamed peripherally, starting with a reamer the same size as the native femoral head. Anteroposterior pelvic radiographs were analysed for acetabular floor depth and vertical and horizontal position of the COR.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 3 | Pages 315 - 321
1 Mar 2012
Coulter G Young DA Dalziel RE Shimmin AJ

We report the findings of an independent review of 230 consecutive Birmingham hip resurfacings (BHRs) in 213 patients (230 hips) at a mean follow-up of 10.4 years (9.6 to 11.7). A total of 11 hips underwent revision; six patients (six hips) died from unrelated causes; and 13 patients (16 hips) were lost to follow-up. The survival rate for the whole cohort was 94.5% (95% confidence interval (CI) 90.1 to 96.9). The survival rate in women was 89.1% (95% CI 79.2 to 94.4) and in men was 97.5% (95% CI 92.4 to 99.2). Women were 1.4 times more likely to suffer failure than men. For each millimetre increase in component size there was a 19% lower chance of a failure. The mean Oxford hip score was 45.0 (median 47.0, 28 to 48); mean University of California, Los Angeles activity score was 7.4 (median 8.0, 3 to 9); mean patient satisfaction score was 1.4 (median 1.0, 0 to 9). A total of eight hips had lysis in the femoral neck and two hips had acetabular lysis. One hip had progressive radiological changes around the peg of the femoral component. There was no evidence of progressive neck narrowing between five and ten years.

Our results confirm that BHR provides good functional outcome and durability for men, at a mean follow-up of ten years. We are now reluctant to undertake hip resurfacing in women with this implant.


The Bone & Joint Journal
Vol. 96-B, Issue 1 | Pages 43 - 47
1 Jan 2014
Craig P Bancroft G Burton A Collier S Shaylor P Sinha A

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 11 | Pages 1439 - 1445
1 Nov 2007
Triclot P Grosjean G El Masri F Courpied JP Hamadouche M

We carried out a prospective randomised study designed to compare the penetration rate of acetabular polyethylene inserts of identical design but different levels of cross-linking at a minimum of four years follow-up. A total of 102 patients (102 hips) were randomised to receive either highly cross-linked Durasul, or contemporary Sulene polyethylene inserts at total hip replacement. A single blinded observer used the Martell system to assess penetration of the femoral head. At a mean follow-up of 4.9 years (4.2 to 6.1) the mean femoral head penetration rate was 0.025 mm/year (sd 0.128) in the Durasul group compared with 0.106 mm/year (sd 0.109) in the Sulene group (Mann-Whitney test, p = 0.0027). The mean volumetric penetration rate was 29.24 mm3/year (sd 44.08) in the Durasul group compared with 53.32 mm3/year (sd 48.68) in the Sulene group. The yearly volumetric penetration rate was 55% lower in the Durasul group (Mann-Whitney test, p = 0.0058). Longer term results are needed to investigate whether less osteolysis will occur.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 11 | Pages 1431 - 1438
1 Nov 2007
Hing CB Back DL Bailey M Young DA Dalziel RE Shimmin AJ

We report an independent prospective review of the first 230 Birmingham hip resurfacings in 212 patients at a mean follow-up of five years (4 to 6).

Two patients, one with a loose acetabular component and the other with suspected avascular necrosis of the femoral head, underwent revision. There were two deaths from unrelated causes and one patient was lost to follow-up. The survivorship with the worst-case scenario was 97.8% (95% confidence interval 95.8 to 99.5). The mean Harris hip score improved significantly (paired t-test, p < 0.05) from 62.54 (8 to 92) pre-operatively to 97.7 (61 to 100) at a mean of three years (2.1 to 4.3), then deteriorated slightly to a mean of 95.2 (47 to 100) at a mean of five years. The mean flexion improved from 91.5° (25° to 140°) to 110.4° (80° to 145°) at a mean of three years with no further improvement at five years (111.2°; 70° to 160°).

On radiological review at five years, one patient had a progressive lucent line around the acetabular component and six had progressive lucent lines around the femoral component. A total of 18 femoral components (8%) had migrated into varus and those with lucent lines present migrated a mean of 3.8° (1.02° to 6.54°) more than the rest. Superolateral notching of the femoral neck and reactive sclerosis at the tip of the peg of the femoral component were associated with the presence of lucent lines (chi-squared test, p < 0.05), but not with migration of the femoral component, and are of unknown significance.

Our results with the Birmingham hip resurfacing continue to be satisfactory at a mean follow-up of five years.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 12 | Pages 1555 - 1560
1 Dec 2009
Lingaraj K Teo YH Bergman N

We investigated the early results of modular porous metal components used in 23 acetabular reconstructions associated with major bone loss. The series included seven men and 15 women with a mean age of 67 years (38 to 81), who had undergone a mean of two previous revisions (1 to 7).

Based on Paprosky’s classification, there were 17 type 3A and six type 3B defects. Pelvic discontinuity was noted in one case. Augments were used in 21 hips to support the shell and an acetabular component-cage construct was implanted in one case. At a mean follow-up of 41 months (24 to 62), 22 components remained well fixed. Two patients required rerevision of the liners for prosthetic joint instability. Clinically, the mean Harris Hip Score improved from 43.0 pre-operatively (14 to 86) to 75.7 post-operatively (53 to 100). The mean pre-operative Merle d’Aubigné score was 8.2 (3 to 15) and improved to a mean of 13.7 (11 to 18) post-operatively.

These short-term results suggest that modular porous metal components are a viable option in the reconstruction of Paprosky type 3 acetabular defects. More data are needed to determine whether the system yields greater long-term success than more traditional methods, such as reconstruction cages and structural allografts.


The Bone & Joint Journal
Vol. 96-B, Issue 7 | Pages 868 - 875
1 Jul 2014
Lübbeke A Gonzalez A Garavaglia G Roussos C Bonvin A Stern R Peter R Hoffmeyer P

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 2 | Pages 202 - 208
1 Feb 2010
Berton C Girard J Krantz N Migaud H

Implantation of a large-diameter femoral head prosthesis with a metal-on-metal bearing surface reduces the risk of dislocation, increases the range of movement, minimises the risk of impingement and, in theory, results in little wear.

Between February 2004 and March 2007 we implanted 100 consecutive total hip replacements with a metal-on-metal bearing and a large femoral head into 92 patients. There were 51 men and 41 women with a mean age of 50 years (18 to 70) at the time of surgery.

Outcome was assessed using the Western Ontario McMaster University osteoarthritis index and the Harris hip score as well as the Devane activity score. These all improved significantly (p < 0.0001). At the last follow-up there were no cases of dislocation, no impingement, a good range of movement and no osteolysis, but seven revisions, two for infection and five for aseptic loosening. The probability of groin pain increased if the other acetabular component inclination exceeded 50° (p = 0.0007). At 4.8 years of follow-up, the projected survival of the Durom acetabular component, with revision for any reason, was 92.4% (sd 2.8) (95% confidence interval 89.6 to 95.2).

The design of the component made it difficult both to orientate and seat, which when combined with a poor porous coating, produced unpredictable fixation and a low survival at five years.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 4 | Pages 456 - 463
1 Apr 2011
Lübbeke A Garavaglia G Barea C Stern R Peter R Hoffmeyer P

We conducted a longitudinal study including patients with the same type of primary hybrid total hip replacement and evaluated patient activity and femoral osteolysis at either five or ten years post-operatively. Activity was measured using the University of California, Los Angeles scale. The primary outcome was the radiological assessment of femoral osteolysis. Secondary outcomes were revision of the femoral component for aseptic loosening and the patients’ quality of life. Of 503 hip replacements in 433 patients with a mean age of 67.7 years (30 to 91), 241 (48%) were seen at five and 262 (52%) at ten years post-operatively. Osteolytic lesions were identified in nine of 166 total hip replacements (5.4%) in patients with low activity, 21 of 279 (7.5%) with moderate activity, and 14 of 58 (24.1%) patients with high activity. The risk of osteolysis increased with participation in a greater number of sporting activities. In multivariate logistic regression adjusting for age, gender, body mass index and the inclination angle of the acetabular component, the adjusted odds ratio for osteolysis comparing high vs moderate activity was 3.6 (95% confidence interval 1.6 to 8.3). Stratification for the cementing technique revealed that lower quality cementing increased the effect of high activity on osteolysis. Revision for aseptic loosening was most frequent with high activity. Patients with the highest activity had the best outcome and highest satisfaction.

In conclusion, of patients engaged in high activity, 24% had developed femoral osteolysis five to ten years post-operatively.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 6 | Pages 755 - 761
1 Jun 2012
Bosker BH Ettema HB Boomsma MF Kollen BJ Maas M Verheyen CCPM

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 11 | Pages 1454 - 1458
1 Nov 2009
Eswaramoorthy VK Biant LC Field RE

We report the outcome of total hip replacement in 29 failed metal-on-metal resurfacing hip replacements in which the primary surgery was performed between August 1995 and February 2005. The mean length of follow-up was five years (1.7 to 11.7). Of the 29 hip resurfacings, 19 acetabular components and all the femoral components were revised (28 uncemented stems and one cemented stem). There were no deaths and none of the patients was lost to follow-up. None of the hips underwent any further revision. The results of the revision resurfacing group were compared with those of a control group of age-matched patients. In the latter group there were 236 primary total hip replacements and 523 resurfacings performed during the same period by the same surgeons.

The outcome of the revision resurfacing group was comparable with that of the stemmed primary hip replacement group but was less good than that of the primary hip resurfacing group. Long-term follow-up is advocated to monitor the outcome of these cases.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 1 | Pages 27 - 33
1 Jan 2011
Treacy RBC McBryde CW Shears E Pynsent PB

We report the survival, radiological and functional outcomes of a single surgeon series of his first 144 consecutive Birmingham hip resurfacing procedures (130 patients) at a minimum of ten years. There were ten revisions during this time. Although no patients were lost to follow-up some did not complete the scoring assessment or undergo radiological assessment at ten years.

The ten-year survival for male patients was 98.0% (95% confidence interval 95.2 to 100). The ten-year survival for the total cohort with aseptic revision as the endpoint was 95.5% (95% confidence interval 91.8 to 99.0) and including revisions for sepsis was 93.5% (95% confidence interval 89.2 to 97.6). The median modified Oxford hip score at ten years was 4.2% (interquartile range 0 to 19) and the median University of California, Los Angeles score was 7.0 (interquartile range 5.0 to 8.0).

This study confirms the midterm reports that metal-on-metal hip resurfacing using the Birmingham Hip provides a durable alternative to total hip replacement, particularly in younger male patients wishing to maintain a high level of function, with low risk of revision for at least ten years.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 5 | Pages 572 - 579
1 May 2011
Haddad FS Thakrar RR Hart AJ Skinner JA Nargol AVF Nolan JF Gill HS Murray DW Blom AW Case CP

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 1 | Pages 20 - 27
1 Jan 2010
Daniel J Ziaee H Kamali A Pradhan C Band T McMinn DJW

Second-generation metal-on-metal bearings were introduced as a response to the considerable incidence of wear-induced failures associated with conventional replacements, especially in young patients. We present the results at ten years of a consecutive series of patients treated using a metal-on-metal hip resurfacing. A distinct feature of the bearings used in our series was that they had been subjected to double-heat treatments during the post-casting phase of their manufacture. In the past these bearings had not been subjected to thermal treatments, making this a unique metal-on-metal bearing which had not been used before in clinical practice.

We report the outcome of 184 consecutive hips (160 patients) treated using a hybrid-fixed metal-on-metal hip resurfacing during 1996. Patients were invited for a clinicoradiological follow-up at a minimum of ten years. The Oxford hip score and anteroposterior and lateral radiographs were obtained. The mean age at operation was 54 years (21 to 75). A series of 107 consecutive hips (99 patients) who received the same prosthesis, but subjected to a single thermal treatment after being cast, between March 1994 and December 1995, were used as a control group for comparison.

In the 1994 to 1995 group seven patients (seven hips) died from unrelated causes and there were four revisions (4%) for osteolysis and aseptic loosening. In the 1996 group nine patients died at a mean of 6.9 years after operation because of unrelated causes. There were 30 revisions (16%) at a mean of 7.3 years (1.2 to 10.9), one for infection at 1.2 years and 29 for osteolysis and aseptic loosening. Furthermore, in the latter group there were radiological signs of failure in 27 (24%) of the 111 surviving hips.

The magnitude of the problem of osteolysis and aseptic loosening in the 1996 cohort did not become obvious until five years after the operation. Our results indicate that double-heat treatments of metal-on-metal bearings can lead to an increased incidence of wear-induced osteolysis.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 3 | Pages 298 - 306
1 Mar 2011
van der Weegen W Hoekstra HJ Sijbesma T Bos E Schemitsch EH Poolman RW

We systematically reviewed the peer-reviewed literature to relate the survival of hybrid metal-on-metal hip resurfacing arthroplasty devices to a National Institute of Clinical Excellence (NICE) benchmark for choosing a primary total hip replacement, which is a survival rate of 90% at a follow-up of ten years.

A total of 29 articles (10 621 resurfaced hips) met the inclusion criteria. The mean follow-up ranged from 0.6 to 10.5 years and the survival of the implant ranged from 84% to 100%. Of the 10 621 hips, 370 were revised (3.5%), with aseptic loosening as the most frequent mode of failure.

None of the hip resurfacing arthroplasty implants used to date met the full ten-year NICE benchmark of survival. A total of 13 studies showed satisfactory survival compared with the three-year NICE benchmark.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 12 | Pages 1566 - 1574
1 Dec 2009
Glyn-Jones S Pandit H Kwon Y Doll H Gill HS Murray DW

Metal-on-metal hip resurfacing is commonly performed for osteoarthritis in young active patients. We have observed cystic or solid masses, which we have called inflammatory pseudotumours, arising around these devices. They may cause soft-tissue destruction with severe symptoms and a poor outcome after revision surgery. The aim of this study was to determine the incidence of and risk factors for pseudotumours that are serious enough to require revision surgery.

Since 1999, 1419 metal-on-metal hip resurfacings have been implanted by our group in 1224 patients; 1.8% of the patients had a revision for pseudotumour. In this series the Kaplan-Meier cumulative revision rate for pseudotumour increased progressively with time. At eight years, in all patients, it was 4% (95% confidence interval (CI) 2.2 to 5.8). Factors significantly associated with an increase in revision rate were female gender (p < 0.001), age under 40 (p = 0.003), small components (p = 0.003), and dysplasia (p = 0.019), whereas implant type was not (p = 0.156). These factors were inter-related, however, and on fitting a Cox proportional hazard model only gender (p = 0.002) and age (p = 0.024) had a significant independent influence on revision rate; size nearly reached significance (p = 0.08). Subdividing the cohort according to significant factors, we found that the revision rate for pseudotumours in men was 0.5% (95% CI 0 to 1.1) at eight years wheras in women over 40 years old it was 6% (95% CI 2.3 to 10.1) at eight years and in women under 40 years it was 13.1% at six years (95% CI 0 to 27) (p < 0.001).

We recommend that resurfacings are undertaken with caution in women, particularly those under 40 years of age but they remain a good option in young men. Further work is required to understand the aetiology of pseudotumours so that this complication can be avoided.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 3 | Pages 296 - 300
1 Mar 2007
van Haaren EH Heyligers IC Alexander FGM Wuisman PIJM

We reviewed the results of 71 revisions of the acetabular component in total hip replacement, using impaction of bone allograft. The mean follow-up was 7.2 years (1.6 to 9.7). All patients were assessed according to the American Academy of Orthopedic Surgeons (AAOS) classification of bone loss, the amount of bone graft required, thickness of the graft layer, signs of graft incorporation and use of augmentation.

A total of 20 acetabular components required re-revision for aseptic loosening, giving an overall survival of 72% (95% CI, 54.4 to 80.5). Of these failures, 14 (70%) had an AAOS type III or IV bone defect. In the failed group, poor radiological and histological graft incorporation was seen.

These results suggest that impaction allografting in acetabular revision with severe bone defects may have poorer results than have previously been reported.


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 5 | Pages 586 - 591
1 May 2006
Wang J Fong C Su Y Yu H

Failure of total hip arthroplasty with acetabular deficiency occurred in 55 patients (60 hips) and was treated with acetabular revision using morsellised allograft and a cemented metal-backed component. A total of 50 patients (55 hips) were available for clinical and radiological evaluation at a mean follow-up of 5.8 years (3 to 9.5). No hip required further revision of the acetabular component because of aseptic loosening.

All the hips except one had complete incorporation of the allograft demonstrated on the radiographs. A complete radiolucent line of > 1 mm was noted in two hips post-operatively. A good to excellent result occurred in 50 hips (91%). With radiological evidence of aseptic loosening of the acetabular component as the end-point, the survivorship at a mean of 5.8 years after surgery was 96.4%.

The use of impacted allograft chips in combination with a cemented metal-backed acetabular component and screw fixation can achieve good medium-term results in patients with acetabular bone deficiency.


The Bone & Joint Journal
Vol. 95-B, Issue 10 | Pages 1326 - 1331
1 Oct 2013
Eilander W Harris SJ Henkus HE Cobb JP Hogervorst T

Orientation of the acetabular component influences wear, range of movement and the incidence of dislocation after total hip replacement (THR). During surgery, such orientation is often referenced to the anterior pelvic plane (APP), but APP inclination relative to the coronal plane (pelvic tilt) varies substantially between individuals. In contrast, the change in pelvic tilt from supine to standing (dPT) is small for nearly all individuals. Therefore, in THR performed with the patient supine and the patient’s coronal plane parallel to the operating table, we propose that freehand placement of the acetabular component placement is reliable and reflects standing (functional) cup position. We examined this hypothesis in 56 hips in 56 patients (19 men) with a mean age of 61 years (29 to 80) using three-dimensional CT pelvic reconstructions and standing lateral pelvic radiographs. We found a low variability of acetabular component placement, with 46 implants (82%) placed within a combined range of 30° to 50° inclination and 5° to 25° anteversion. Changing from the supine to the standing position (analysed in 47 patients) was associated with an anteversion change < 10° in 45 patients (96%). dPT was < 10° in 41 patients (87%). In conclusion, supine THR appears to provide reliable freehand acetabular component placement. In most patients a small reclination of the pelvis going from supine to standing causes a small increase in anteversion of the acetabular component.

Cite this article: Bone Joint J 2013;95-B:1326–31.


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 10 | Pages 1308 - 1313
1 Oct 2011
Hart AJ Sabah SA Bandi AS Maggiore P Tarassoli P Sampson B A. Skinner J

Blood metal ions have been widely used to investigate metal-on-metal hip replacements, but their ability to discriminate between well-functioning and failed hips is not known. The Medicines and Healthcare products Regulatory Agency (MHRA) has suggested a cut-off level of 7 parts per billion (ppb).

We performed a pair-matched, case-control study to investigate the sensitivity and specificity of blood metal ion levels for diagnosing failure in 176 patients with a unilateral metal-on-metal hip replacement. We recruited 88 cases with a pre-revision, unexplained failed hip and an equal number of matching controls with a well-functioning hip. We investigated the 7 ppb cut-off level for the maximum of cobalt or chromium and determined optimal mathematical cut-off levels from receiver-operating characteristic curves.

The 7 ppb cut-off level for the maximum of cobalt or chromium had a specificity of 89% and sensitivity 52% for detecting a pre-operative unexplained failed metal on metal hip replacement. The optimal cut-off level for the maximum of cobalt or chromium was 4.97 ppb and had sensitivity 63% and specificity 86%.

Blood metal ions had good discriminant ability to separate failed from well-functioning hip replacements. The MHRA cut-off level of 7 ppb provides a specific test but has poor sensitivity.