Continued mid-term stability of a novel cementless femoral stem design: A radiostereometric analysis study

Abstract

Background: Measuring early micromotion using radiostereometric analysis is the gold standard to evaluate new implant performance. The aim of this study was to assess the continued stability of a new cementless Paragon stem at 5 years. Secondary aims were to assess patient reported outcomes and compare the continued stability between 2 and 5 year to an existing gold standard, the Corail stem.

Methods: This is a brief follow-up report of a radiostereometric analysis study. Of the original 46 patients in the 2 year study, four patients were lost to follow-up, three had died, five relocated interstate and seven withdrew from the study. We prospectively reviewed 27 primary total hip arthroplasty patients who underwent radiographic examinations at 5 years for beaded radiostereometric analysis measurements of stem translational and rotation migration.

Findings: Median subsidence of the Paragon stem at 5 years was -0.428 mm (range - 0.107 to -1.092) and the median stem subsidence between 2 and 5 years was -0.010 mm (0.115 to -0.269). When compared to the historical Corail stem stability between two and six years, the Paragon stem demonstrated similar subsidence (p = 0.09); and significantly less medial translation (p = 0.0033), anterior translation (p < 0.0001), anterior tilt (p = 0.0004) and anteversion (p = 0.015) between 2 and 5 years. The mean Oxford Hip Score improved substantially within the first year and did not decrease between 2 (44.7, SD 5.9) and 5 years (44.0, SD 8).

Interpretation: The Paragon stem showed continued stability up to 5 years follow-up which is encouraging for the further clinical use of this new design.

Keywords: Clinical outcome; Orthopaedic surgery; Radiostereometric analysis; Total hip arthroplasty; Uncemented femoral stem, implant migration, prosthesis.