Similar 2 year migration patterns for a shortened and a distally reduced stem design in uncemented total hip arthroplasty: a randomized controlled trial using radiostereometric analysis

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BACKGROUND AND PURPOSE: The primary objective was to compare subsidence and retroversion in the first 2 postoperative years of 2 uncemented hip stem designs in primary minimally invasive anterior-supine surgical (MIS-ASI) total hip arthroplasty: a shortened hip stem (Microplasty) and a standard-length stem with reduced distal width (Reduced Distal). Secondary objectives were to compare migration patterns, patient-reported outcome measures (PROMs), clinical and radiological scores, and the occurrence of (serious) adverse events up to 2 years postoperatively. METHODS: 50 patients were randomized in this non-blinded, single-surgeon, industry-funded, radiostereometric analysis study (RSA) (ClinicalTrials.gov NCT03409666). Stem migration was measured relative to directly postoperative at 6 weeks, 1 year, and 2 years postoperatively, using model-based RSA. Linear mixed-effect modelling was used to compare migration. Primary outcomes were subsidence and retroversion at 2 years postoperatively. Secondary outcomes were migration, PROM questionnaires, clinical and radiological scores, and the presence of adverse events in the first 2 postoperative years. RESULTS: Migration of 15 Microplasty and 20 Reduced Distal stems showed comparable initial migration between direct and 6 weeks postoperative RSA, stabilizing thereafter. Predominant migration directions were subsidence and retroversion with mean values at 2 years of 1.47 mm (95% confidence interval [CI] 0.32-2.61) and 2.57° (CI 1.64-3.50) for the Microplasty stem and 2.35 mm (CI 1.36-3.34) and 1.59° (CI 0.79-2.39) for the Reduced Distal stem. At 6 weeks postoperatively, posterior tilt about the medial-lateral axis was different between stem designs, with 0.07° (CI -0.27 to 0.40) for the Microplasty and 0.48° (CI 0.19-0.77) for the Reduced Distal designs. Secondary outcomes were not clinically different between the stem designs. CONCLUSION: We showed that initial subsidence and retroversion for both stem designs in MIS-ASI surgery was present, although likely not clinically relevant. There was no statistically significant difference in subsidence and retroversion between the stem designs. Although initial migration varied substantially between patients and the Reduced Distal design showed more posterior tilting, both designs maintained a stable position from 6 weeks to 2 years postoperatively.

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