Abstract
Background
Safety and efficacy of novel prostheses relies on the determination of early implant migration and subsequent risk of loosening. Radiostereometric Analysis (RSA) has been used to evaluate the clinical failure risks of femoral stems by reporting distal migration, a measure of stem subsidence, when examining early migration characteristics. The migratory patterns of femoral stems, 24 months postoperatively, have provided a surrogate outcome measure to determine implant stabilisation and predict long-term performance and survivorship. RSA assessed femoral stem migration and provided comparison of the early migration characteristics with published data of a clinically established counterpart.
Methods
Twenty five patients undergoing primary total hip arthroplasty were implanted with a hydroxyapatite-coated femoral stem. The median age was 65 years (range, 43–75 years). During surgery tantalum markers were attached onto the distal tip and shoulder of the stem. Eight tantalum markers were inserted into the femur, four placed in each of the greater and lesser trochanter. RSA examinations were performed postoperatively at 4 to 5 days, 6, 12 and 24 months. Eleven patients who had complete RSA follow-up as well as the valid data from five patients were analysed to determine the movement of the femoral stem relative to the femur and were compared to the published data of a clinically established counterpart.
Results
At 24 months the magnitude of migration of the femoral stem translations for the y axis of movement was 0.32 mm (range, 0.00 to 2.04 mm) (Figure 1). The data demonstrates that this migration of the femoral stem occurred primarily in the first 6 months postoperatively and that the migration characteristics exhibit a pattern of implant stabilisation between 6 and 24 months. At 24 months the magnitude of migration of the femoral stem rotations for the longitudinal y axis of movement was 0.60o (range, 0.08 to 2.08o). The data demonstrates continuing migration of the femoral stem at 12 months postoperatively with early indications of implant stabilisation between 12 and 24 months.
At 24 months the mean subsidence/distal migration of the femoral stem was 0.20 mm (range, −2.04 to 0.32 mm) (Figure 2). At 6 months, two patients (12.5%) exhibited subsidence greater than 0.50 mm with one demonstrating a mean subsidence of 2.00 mm. Between 6 and 24 months these two patients exhibited no more than 0.04 mm of subsidence (Figure 3). The mean retroversion rotation of the stem was 0.10o (range, −0.99 to 2.08o). One patient rotated more than 2.00o into retroversion at 12 and 24 months postoperatively.
Conclusions
In comparison the data demonstrates less stem subsidence and retroversion rotation than published data for a cementless hydroxyapatite-coated femoral stem when observing early migration characteristics. The magnitude and pattern of migration exhibited is indicative of good clinical outcomes and is comparable with a clinically established counterpart after short-term follow-up with RSA. These findings and comparisons highlight the early migration characteristics of a hydroxyapatite-coated femoral stem, however the analysis and comparison of the migratory pattern and characteristics over the mid-term follow-up will confirm implant stabilisation.
