Abstract
Total hip arthroplasty (THA) is one of the most successful and commonly performed surgical interventions worldwide. Based on registry data, at one-year post THA, implant survivorship is nearly 100% and patient satisfaction is 90%. A novel, porous coated acetabular implant was introduced in Europe and Australia in 2007. Several years after its introduction, warnings were issued for the system when used with metal-on-metal bearings due to adverse local tissue reaction, with one study reporting a 24% failure rate (Dramis et al. 2014). A subsequent 2018 study by Teoh et al. showed that the acetabular system had a survival rate of 98.9% at five years when used with conventional polyethylene or ceramic bearing surfaces. The current study was conducted to determine the safety and effectiveness of the acetabular system using standard highly-crosslinked polyethylene (XLPE) and ceramic liners at five-year follow-up. Our hypothesis was that the acetabular system would exhibit survivorship comparable to other acetabular components on the market at five-year follow-up.
A prospective, non-randomized study was conducted from February 2009 to June 2017 at eight sites in Canada and the USA. One hundred fifty-five hips were enrolled and 148 hips analyzed after THA indicated for degenerative arthritis. At five-year follow-up, 103 subjects remained for final analysis. All patients received a zero, three, or multi-hole R3 acetabular shell with Stiktite porous coating (Smith & Nephew, Inc., Memphis, TN, USA). Standard THA surgical techniques were employed, with surgical approach and either of a XLPE or ceramic bearing surface chosen at the discretion of the surgeon. The primary outcome was revision at five-years post-op with secondary outcomes including the Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), radiographic analysis, and post-operative adverse events. Data and outcomes were analyzed using summary statistics with 95% confidence intervals, t-tests, and Wilcoxon Rank tests.
At five-year follow-up the overall success rate was 97.14% (95% CI: 91.88–100). When analyzed by liner type, the success rate was 96.81% (95% CI: 90.96–99.34) for polyethylene (n=94) and 100% (95% CI: 71.51–100) for ceramic (n=11), with no significant difference between either liner type (p=1). There were three revisions during the study (1.9%), two for femoral stem revision post fracture, and one for deep infection. The HHS (51.36 pre-op, 94.50 five-year), all 5 HOOS sub-scales, and WOMAC (40.9 pre-op, 89.13 five-year) scores all significantly improved (p < 0 .001) over baseline scores at all follow-up points. One (0.7%) subject met the criteria for radiographic failure at one-year post-op but did not require revision. Six (1.8%) of the reported adverse events were considered related to the study device, including four cases of squeaking, one bursitis, and one femur fracture.
Results from this five-year, multicenter, prospective study indicate good survivorship for this novel, porous coated acetabular system. The overall survivorship of 97.14% at five-year follow-up is comparable to that reported for similar acetabular components and aligns with previous analyses (Teoh et al. 2018).
