The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement

Madanat, Rami; Hussey, Daniel K.; Donahue, Gabrielle S.; Potter, Hollis G.; Wallace, Robert; Bragdon, Charles R.; Muratoglu, Orhun K.; Malchau, Henrik

doi:10.1016/j.arth.2015.04.036

Cited by 12 publications

(10 citation statements)

References 32 publications

(47 reference statements)

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“…This observation is also compatible with the process of a patient becoming sensitised to excessive metal debris from a malfunctioning joint, with a negative immune cascade subsequently precipitated by small amounts of metal generated from a well-functioning joint. 21 …”

Section: Discussionmentioning

confidence: 99%

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Retrospective cohort study of the performance of the Pinnacle metal on metal (MoM) total hip replacement: a single-centre investigation in combination with the findings of a national retrieval centre

et al. 2016

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ObjectivesTo determine risk factors for revision in patients implanted with a commonly used metal on metal (MoM) hip replacement.DesignRetrospective cohort study in combination with a prospective national retrieval study (Northern Retrieval Registry (NRR)).SettingCombined orthopaedic unit in combination with the NRR.ParticipantsAll patients implanted with a DePuy Pinnacle MoM hip prostheses by the 2 senior authors were invited to attend for a review which included clinical examination, blood metal ion measurements, radiographs and targeted imaging. Explanted components underwent wear analysis using validated methodology and these results were compared with those obtained from the NRR.Results489 MoM Pinnacle hips were implanted into 434 patients (243 females and 191 males). Of these, 352 patients attended the MoM recall clinics. 64 patients had died during the study period. For the purposes of survival analysis, non-attendees were assumed to have well-functioning prostheses. The mean follow-up of the cohort as a whole was 89 months. 71 hips were revised. Prosthetic survival for the whole cohort was 83.6% (79.9–87.3) at 9 years. The majority of explanted devices exhibited signs of taper junction failure. Risk factors for revision were bilateral MoM prostheses, smaller Pinnacle liners, and implantation in 2006 and later years. A significant number of devices were found to be manufactured out of their specifications. This was confirmed with analysis of the wider data set from the NRR.ConclusionsThis device was found to have an unacceptably high revision rate. Bilateral prostheses, those implanted into female patients and devices implanted in later years were found to be at greater risk. A significant number of explanted components were found to be manufactured with bearing diameters outside of the manufacturer's stated tolerances. Our findings highlight the clinical importance of hitherto unrecognised variations in device production.

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Section: Discussionmentioning

confidence: 99%

“…20 In our own experience, devices with no excessive wear with associated ARMD are commonly found in patients with bilateral devices implying a process of sensitisation. 21 …”

Section: Introductionmentioning

confidence: 99%

Retrospective cohort study of the performance of the Pinnacle metal on metal (MoM) total hip replacement: a single-centre investigation in combination with the findings of a national retrieval centre

et al. 2016

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“…The median cup inclination angle was 44°(range, 21°-74°) for males and 45°(range, 23°-79°) for females (p = 0.37) ( Table 1). Subcohort B was a subset of Cohort A; it included all patients from Cohort A who came from one center where metal artifact reduction sequence protocol MRI is performed annually [22]. One hundred fifty (171 hips) of the 161 patients (185 hips) undergoing annual followups at this center had MRI performed and comprised Cohort B.…”

Section: Participants/study Subjectsmentioning

confidence: 99%

“…The severity was classified using the grading system of Anderson et al [2,22]. MRI assessment was performed by one of the authors (RM) with 2 years of experience and was validated by a musculoskeletal radiologist (HP) with more than 10 years of experience reading metal artifact reduction sequence protocol MR images.…”

Section: Participants/study Subjectsmentioning

confidence: 99%

Are Females at Greater Risk for Revision Surgery After Hip Resurfacing Arthroplasty With the Articular Surface Replacement Prosthesis?

Donahue

Lindgren

Galea

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background Female patients undergoing hip resurfacing arthroplasties may be at greater risk of revision surgery than males, but it is unclear whether this is related to sex or other factors. We focused our analysis on data from a prospective multicenter cohort study monitoring the ASR TM hip resurfacing arthroplasty prosthesis on the potential association of sex on patient-reported outcome measures (PROMs), metal ion levels, revision surgery, and presence of adverse local tissue reaction. As thousands of patients with the ASR TM prosthesis are still undergoing followup it is critical to optimize the protocol for monitoring these patients.Questions/purposes We wished (1) to assess the associations between sex and implant survival, and adverse local tissue reaction; and (2) to report the differences between sexes in metal ion levels and patient-reported outcome measures. Methods One thousand two hundred fifty-two patients (1390 hips) who underwent hip resurfacing arthroplasty with implantation of the ASR TM prosthesis from April 2003 to July 2010 were eligible for enrollment in a multicenter followup study of the ASR TM Hip Resurfacing System after the voluntary recall of this device was initiated by DePuy in 2010. Nine hundred seventy patients (1098 hips) were enrolled at a mean of 7 years after surgery, with a mean followup of 2 years (range, 1-3.5 years). One of the authors (OM), or a member of his immediate family, has or may receive payments or benefits, during the study period, an amount of USD 10,000 to USD 100,000, from Zimmer Inc, Biomet, Corin (Cirencester, UK), Iconacy (Warsaw, IN, USA), Renovis (Redlands, CA, USA), Conformis (Burlington, MA, USA), Aston Medical (Saint-É tienne, France), Meril Healthcare (Vapi, Gujarat, India), Arthex (Naples, FL, USA), Mako Surgical Corp, Cambridge Polymer Group (Boston, MA, USA), and Orthopedic Technology Group (Boston, MA, USA). One of the authors (HM), or a member of his immediate family, has or may receive payments or benefits, during the study period, an amount of USD 10,000 to USD 100,000, from Zimmer Inc, Biomet, Corin, and RSA Biomedical (Umeå, Sweden Nine hundred fifty-eight patients (1084 hips) met the inclusion criteria: ability to provide informed consent, complete PROMs, and continued routine followup. A subset of patients (150 patients, 171 hips), who all were from one center, with annual metal artifact reduction sequence MRI were analyzed. Ninety-three percent of patients from this center had routine MRI performed. The EuroQoL (EQ-5D), Harris hip score (HHS), University of California Los Angeles (UCLA) activity score, VAS pain, radiographs, patient and surgery details, and blood cobalt and chromium levels were obtained. Cox regression analysis was conducted to identify factors associated with implant survival, using any revision as the end point, and presence of adverse local tissue reaction. Results In patients who had unilateral surgery, the only variable found to be associated with revision surgery was HHS (hazard ratio [HR], 0.96; 95% CI, 0.9...

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“…43-45 Bilateral failures seem to occur in patients undergoing sequential hip implantation, with suggestion that a delayed type IV immune reaction is responsible. 43-45 We observed patients with bilateral MoM hip arthroplasties to be at high risk of implant failure, which confirms recent findings in another 36 mm MoM Pinnacle THA cohort 10 but is contrary to that reported in large hip resurfacing cohorts. 32 Bilateral MoM THAs may have a higher risk of failure compared with bilateral hip resurfacings given recent observations that metal debris generated from taper junctions can be more immunogenic than that from bearing surfaces.…”

Section: Discussionmentioning

confidence: 99%

Risk factors for failure of the 36 mm metal-on-metal Pinnacle total hip arthroplasty system

Matharu

Nandra

Berryman

et al. 2017

The Bone & Joint Journal

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AimsTo determine ten-year failure rates following 36 mm metal-on-metal (MoM) Pinnacle total hip arthroplasty (THA), and identify predictors of failure.Patients and MethodsWe retrospectively assessed a single-centre cohort of 569 primary 36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012 according to Medicines and Healthcare Products Regulation Agency recommendations. All-cause failure rates (all-cause revision, and non-revised cross-sectional imaging failures) were calculated, with predictors for failure identified using multivariable Cox regression.ResultsFailure occurred in 97 hips (17.0%). The ten-year cumulative failure rate was 27.1% (95% confidence interval (CI) 21.6 to 33.7). Primary implantation from 2006 onwards (hazard ratio (HR) 4.30; 95% CI 1.82 to 10.1; p = 0.001) and bilateral MoM hip arthroplasty (HR 1.59; 95% CI 1.03 to 2.46; p = 0.037) predicted failure. The effect of implantation year on failure varied over time. From four years onwards following surgery, hips implanted since 2006 had significantly higher failure rates (eight years 28.3%; 95% CI 23.1 to 34.5) compared with hips implanted before 2006 (eight years 6.3%; 95% CI 2.4 to 15.8) (HR 15.2; 95% CI 2.11 to 110.4; p = 0.007).ConclusionWe observed that 36 mm MoM Pinnacle THAs have an unacceptably high ten-year failure rate, especially if implanted from 2006 onwards or in bilateral MoM hip patients. Our findings regarding implantation year and failure support recent concerns about the device manufacturing process. We recommend all patients undergoing implantation since 2006 and those with bilateral MoM hips undergo regular investigation, regardless of symptoms.Cite this article: Bone Joint J 2017;99-B:592–600.

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The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement

Cited by 12 publications

References 32 publications

Retrospective cohort study of the performance of the Pinnacle metal on metal (MoM) total hip replacement: a single-centre investigation in combination with the findings of a national retrieval centre

Retrospective cohort study of the performance of the Pinnacle metal on metal (MoM) total hip replacement: a single-centre investigation in combination with the findings of a national retrieval centre

Are Females at Greater Risk for Revision Surgery After Hip Resurfacing Arthroplasty With the Articular Surface Replacement Prosthesis?

Risk factors for failure of the 36 mm metal-on-metal Pinnacle total hip arthroplasty system

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