Abstract
This study used model-based radiostereometric analysis (MBRSA) to compare migration of a recently introduced cementless hip stem to an established hip stem of similar design. Novel design features of the newer hip stem included a greater thickness of hydroxyapatite coating and a blended compaction extraction femoral broach.
Fifty-seven patients requiring primary total hip arthroplasty (THA) were enrolled at a single centre. Patients were randomized to receive either an Avenir collarless stem and Trilogy IT cup (ZimmerBiomet) or a Corail collarless stem and Pinnacle cup (DePuy Synthes) via a posterior or lateral approach. Both stems are broach-only femoral bone preparation. RSA beads (Halifax Biomedical) were inserted into the proximal femur during surgery. Patients underwent supine RSA imaging a 6 weeks (baseline), 6, 12, and 24 months following surgery. The primary study outcome was total subsidence of the hip stem from baseline to 24 months as well as progression of subsidence between 12 and 24 months. These values were compared against published migration thresholds for well-performing hip stems (0.5mm). The detection limit, or precision, of MBRSA was calculated based on duplicate examinations taken at baseline. Patient reported outcome measures were collected throughout the study and included the Oxford-12 Hip Score (OHS), EuroQoL EQ-5D-5L, Hip Osteoarthritis Score (HOOS) as well as visual analogue scales (VAS) for thigh pain and satisfaction. Analysis comprised of paired and unpaired t-tests with significance set at p≤0.05.
Forty-eight patients (30 males) were included for analysis; 7 patients received a non-study hip stem intra-operatively, 1 patient suffered a traumatic dislocation within three weeks of surgery, and 1 patient died within 12 months post-surgery. RSA data was obtained for 45 patients as three patients did not receive RSA beads intra-operatively. Our patient cohort had a mean age of 65.9 years (±;7.2) at the time of surgery and body mass index of 30.5 kg/m2 (±;5.2). No statistical difference in total stem migration was found between the Avenir and Corail stems at 12 months (p=0.045, 95%CI: −0.046 to 0.088) and 24 months (p=0.936, 95% CI: −0.098 to 0.090). Progression of subsidence from 12-24 months was 0.011mm and 0.034mm for the Avenir and Corail groups which were not statistically different (p=0.163, 95%CI: −0.100 to 0.008) between groups and significantly less than the 0.5mm threshold (pNo statistically significant differences existed between study groups for any pre-operative function scores (p>0.05). All patients showed significant functional improvement from pre- to post-surgery and no outcome measures were different between study groups with exception of EQ-5D-5L health visual analogue scale at 12 months which showed marginally superior (p=0.036) scores in the Avenir group. This study was not powered to detect differences in clinical outcomes.
This study has demonstrated no statistical difference in subsidence or patient-reported outcomes between the Corail hip stem and the more recently introduced Avenir hip stem. This result is predictable as both stems are of a triple-tapered design, are coated with hydroxyapatite, and utilize a broach-only bone preparation technique. Both stem designs demonstrate migration below 0.5mm suggesting both are low-risk for aseptic loosening in the long-term.
