When following patients with metal-on-metal (MoM) hip replacements, current evidence suggests that orthopaedic surgeons should avoid reliance on any single investigative tool. In 2014, guidelines for stratifying patients with MoM hip replacement into groups of low, medium, and high risk of failure based on multiple criteria were published. However, such risk stratification guidelines can be difficult to interpret due to the numerous risk factors related to MoM hip replacements. This is especially true for patients with various (high and low) risk levels for different criteria within the guidelines. The first purpose of this study was to assess if a scoring system can be applied to the current MoM guidelines. The second purpose was to test, using this scoring system, how the contemporary guidelines would classify a cohort of patients with a recalled MoM hip replacement system. The study population consisted of 1301 patients (1434 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study of a recalled MoM hip replacement system at a mean of 6.2 (range 2.4 – 11.2) years from index surgery. Eleven required scoring criteria were determined based on existing follow-up algorithm recommendations and consisted of patient factors, symptoms, clinical status, implant type, metal ion levels, and radiographic imaging results. Criteria considered ‘low’ risk were given 1 point, 2 points for ‘moderate’ risk, and 3 points for the ‘high’ risk group. Forward stepwise logistic regression was conducted to determine the minimum set of predictive variables for risk of revision and assign variable weights. The MoM risk score for each hip was then created by averaging the weighted values of each predictive variable.Introduction
Methods
Complication and revision rates have shown to be high for all metal-on-metal (MoM) bearings, especially for the ASR Hip System (ASR hip resurfacing arthroplasty (HRA) and ASR XL total hip arthroplasty (THA)). This prompted the global recall of the ASR Hip System in 2010. Many studies have previously explored the association between female gender and revision surgery MoM HRA implants; yet less research has been dedicated to exploring this relationship in MoM THA. The first purpose of this study was to assess the associations between gender and implant survival, as well as adverse local tissue reaction (ALTR), in patients with MoM THA. Secondly, we sought to report the differences between genders in metal ion levels and patient reported outcome measures (PROMs) in patients with MoM THA. The study population consisted of 729 ASR XL THA patients (820 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study at a mean of 6.4 (3–11) years from index surgery. The mean age at the time of index surgery was 60 (22–95) years and 338 were women (46%). All patients enrolled had complete patient and surgical demographic information, blood metal ion levels and PROMs obtained within 6 months, and a valid AP pelvis radiograph dating a maximum of 2 years prior to consent. Blood metal ion levels and PROMs were then obtained annually after enrollment. A sub-set of patients from a single center had annual metal artifact reduction sequence (MARS) MRI performed and were analyzed for the presence of moderate-to-severe ALTR.Introduction
Methods
Studies of metal-on-metal (MoM) hip resurfacing arthroplasty (HRA) have reported high complication and failure rates due to elevated metal ion levels. These rates were shown to be especially high for the Articular Surface Replacement (ASR) HRA, possibly due to its unique design. Associations between metal ion concentrations and various biological and mechanical factors have been reported. Component positioning as measured by acetabular inclination has been shown to be of especially strong consequence in metal ion production in ASR HRA patients, but few studies have evaluated acetabular anteversion as an independent variable. The primary objective of this study was to evaluate the associations between component orientation, quantified by acetabular inclination and anteversion, and blood metal ions. Secondly, we sought to report whether conventional safe zones apply to MoM HRA implants or if these implants require their own positioning standards. We conducted a multi-center, prospective study of 512 unilateral ASR HRA patients enrolled from September 2012 to June 2015. At time of enrollment our patients were a mean of 7 (3–11.5) years from surgery. The mean age at surgery was 56 years and 24% were female. All subjects had complete demographic and surgical information and blood metal ions. In addition, each patient had valid AP pelvis and shoot-though lateral radiographs read by 5 validated readers measuring acetabular abduction and anteversion, and femoral offset. A multivariate logistic regression was used with high cobalt or chromium (greater than or equal to 7ppb) as the dependent variable. The independent variables were: female gender, UCLA activity score, age at surgery, femoral head size, time from surgery, femoral offset, acetabular abduction, and acetabular anteversion.Introduction
Methods
