The in vivo migration and micromotion of the TriFit TS femoral stem
Research type
Research Study
Full title
Investigation of the in-vivo migration and micromotion in the Corin Tri-Fit TS femoral hip system using Radiostereometric Analysis (RSA)
IRAS ID
155394
Contact name
Sion Glyn-Jones
Contact email
Sponsor organisation
Clinical Trials and Research Governance Joint Research Office
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Research Summary:
Hip replacements are being performed on an increasingly active population, who are likely to wear their implants out prematurely. New hip replacements have been devised to minimise the risk of failure. We propose a cohort study designed to investigate the performance of a new type of bone conserving hip replacement. To do this we will use an advanced 3D X-ray technique. This study will be held at a single site(Nuffield Orthopaedic Centre) and is partly funded by CORIN. Participants will be recruited from outpatient clinics held by the chief investigator and other consultant orthopaedic consultants listed as con-investigators.Summary of Results:
Aims: The aim of this prospective cohort study was to evaluate the early migration of the TriFit cementless proximally coated tapered femoral stem using radiostereometric analysis (RSA).Methods: A total of 21 patients (eight men and 13 women) undergoing primary total hip arthroplasty (THA) for osteoarthritis of the hip were recruited in this study and followed up for two years. Two patients were lost to follow-up. All patients received a TriFit stem and Trinity Cup with a vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene liner. Radiographs for RSA were taken postoperatively and then at three, 12, and 24 months. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and adverse events were reported.
Results: At two years, the mean subsidence of the head and tip for the TriFit stem was 0.38 mm (SD 0.32) and 0.52 mm (SD 0.36), respectively. The total migration of the head and tip was 0.55 mm (SD 0.32) and 0.71 mm (SD 0.38), respectively. There were no statistically significant differences between the three to 12 months' migration (p = 0.105) and 12 to 24 months' migration (p = 0.694). The OHS and EQ-5D showed significant improvements at two years.
Conclusion: The results of this study suggest that the TriFit femoral stem achieves initial stability and is likely to be stable in the mid and long term. A long-term outcome study is required to assess late mechanisms of failure and the effects of bone mineral density (BMD) related changes. Cite this article: Bone Joint J 2021;103-B(4):644-649.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0268
Date of REC Opinion
14 May 2015
REC opinion
Favourable Opinion