Early Lessons From a Worldwide, Multicenter, Followup Study of the Recalled Articular Surface Replacement Hip System

Abstract

Background Adverse local tissue reactions (ALTRs) around hip arthroplasties are an important reason for failure of metal-on-metal (MoM) hip implants. Little is known about capsular dehiscence patterns as ALTRs decompress from the hip into the surrounding tissue planes; these patterns may also influence the onset and severity of patient symptoms. Questions/purposes Through a multicenter study approach, we asked: (1) Is ALTR location related to the surgical approach used for arthroplasty in patients who underwent hip arthroplasty (resurfacing or THA) with a single, recalled hip arthroplasty system? (2) Do ALTR severity and location affect patient-reported outcomes in these patients? (3) The institution of one of the authors (HGP) has received, during the study period, funding from GE Healthcare (Waukesha, WI, USA). One of the authors (CB), or a member of his or her 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. One of the authors (OM), or a member of his or her immediate family, has or may receive payments or benefits, during the study period, an amount of less than USD 10,000 from 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), Orthopaedic Technology Group (Boston, MA, USA); USD 10,000 to USD 100,000, from Mako Surgical Corp; USD 100,000 to USD 1,000,000 from Zimmer Inc; and more than USD 1,000,000 from Biomet and Cambridge Polymer Group (Boston, MA, USA). One of the authors (HM), or a member of his or her 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). Clinical Orthopaedics and Related Research ®A Publication of The Association of Bone and Joint Surgeons® 288 patients (333 hips) from two centers had a metal artifact reduction sequence MRI of the hip performed at a mean time of 6 years postsurgery. Procedures included 166 hips (50%) with ASR resurfacing and 167 hips (50%) with ASR XL THA performed between 2004 and 2010. One hundred twenty-nine hips (39%) had been operated on using a direct lateral approach and 204 using a posterior approach (61%). The EQ-5D, Harris hip score, UCLA activity score, and visual analog scale pain score were obtained for each patient. ALTRs were classified using the Anderson ALTR grading system, and the location, synovial thickness, and diameter of the ATLRs were assessed. The relationship between ALTR location and surgical approach as well as for ALTR severity and patient-reported outcomes were evaluated, and logistic regression was used to identify predictors for moderate-to-severe ALTRs. Results Moderate or severe ALTRs were identified in 79 hips (24%); 41 of these hips had been operated on using the direct lateral approach and 38 using the posterior approach. In patients...

Initial metal ion levels predict risk of elevation in metal on metal total hip arthroplasty

“…Screening patients with metal ion levels was not common practice until around 2010, coinciding with the time that the ASR THA (DePuy, Warsaw, IN, USA) was recalled. 5 Prior to this time, metal ion screening was only available at certain centers, but not widely available throughout the United States. Therefore, the first metal ion level that most patients have would likely be years after the MoM THA was performed after the widespread availability of the metal ion test.…”

“…[1][2][3] The theoretical benefits of improved wear characteristics and the ability to utilise a larger femoral head size with the same acetabular shell have been negated by the risk of developing an adverse local tissue reaction (ALTR). 4 , 5 Secondarily, the revision rates following MoM THA have been significantly higher than those of metal on polyethylene THAs. 6 Tissue damage is likely multifactorial, but appears to be related to the release of cobalt and chromium from the implant.…”

Advances in MRI around metal

“…With improving techniques MRI may become more sensitive . With metal‐on‐metal total hip arthroplasty (THA) and the associated major risk of adverse local tissue reactions (ALTR), MARS gained importance . But also with other types of orthopedic implants the so‐called “pseudotumors,” initiated by excessive wear, may be observed .…”

“…In the algorithmic approach to diagnosis and management of metal‐on‐metal arthroplasty published in 2012 by the hip society, imaging should include ultrasound or metal artifact reduction sequence MRI in addition to plain radiography . MARS sequences including VAT and SEMAC have been shown to be useful for detection, staging, and progression analyses of adverse local tissue reactions (ALTR) in the context of metal‐on‐metal hip prostheses . Several studies reported ALTR findings on MRI in up to a third of asymptomatic patients, and despite missing laboratory findings, there is no significant relation between MRI findings and pain or a priori risk factors, which underlines the importance of MRI .…”

Current evidence from a worldwide, multicentre, follow-up study of the recalled Articular Surface Replacement Hip System

“…A detailed description of the study structure and the clinical variables collected is given in a previously published study. 15 As of 31 January 2018, all patients have either completed or exited the window for the 2-year visit. Data from the enrollment, 1-year, and 2-year visits were considered for the present analyses.…”