A PROSPECTIVE, MULTICENTRE RANDOMIZED COMPARATIVE STUDY ASSESSING A NEW MORPHOMETRIC-DESIGNED STEM FOR TOTAL HIP ARTHROPLASTY: BENCHMARKING AGAINST AN ESTABLISHED COMPARATOR

Abstract

Clinical success of prostheses in joint arthroplasty is ultimately determined by survivorship and patient satisfaction. The purpose of this study was to compare (non-inferiority) a new morphometric designed stem for total hip arthroplasty (THA) against an established comparator.A prospective randomised multi-centre study of 144 primary cementless THA performed by nine experienced orthopaedic surgeons was completed (70 received a fully coated collarless tapered stem and 70 received a morphometric designed proximally coated tapered stem). PROMs and blood serum markers were assessed preoperatively and at intervals up to 2-years postoperatively. In addition, measures of femoral stem fit, fill and subsidence at 2-years post-operatively were measured from radiographs by three observers, with an intra-class correlation coefficient of 0.918. A mixed effects model was employed to compare the two prostheses over the study period. A p-value <0.05 was considered statistically significant.Demographics and Dorr types were similar between groups. Both stems demonstrated a significant improvement in PROMs between the pre- and post-operative measurements, with no difference at any timepoint (p > 0.05). The fully coated tapered collarless femoral stem had a non-significantly higher intra-operative femoral fracture rate (5.8% vs 1.4%, p = 0.24), with all patients treated with cable fixation and partial weight bearing. The mean subsidence at 2-years was 2.5mm +/- 2.3mm for the morphometric stem and 2.4mm +/- 1.8mm for the fully coated tapered collarless femoral stem (p = 0.879). There was one outlier in each group with increased subsidence (fully coated tapered collarless femoral stem 6.9mm, morphometric wedge stem 7.4mm), with both patients reporting thigh pain at 2 years.When compared with an established stem, the newer designed morphometric wedge stem performed well with comparable radiological and PROM outcomes at 2 year follow up. Continued follow-up is required for long term benchmarking.