Abstract
INTRODUCTION
Historically, the clinical performance of novel implants was usually reported by designer surgeons who were the first to acquire clinical data. Regional and national registries now provide rapid access to survival data on new implants and drive ODEP ratings. To assess implant performance, clinical and radiological data is required in addition to implant survival. Prospective, multi-surgeon, multi-centre assessments have been advocated as the most meaningful. We report the preliminary results of such a study for the MiniHip™femoral component and Trinity™ acetabular component (Corin Ltd, UK).
METHODS
As part of a non-designer, multi-surgeon, multi-centre prospective surveillance study to assess the MiniHip™stem and Trinity™ cup, 535 operations on 490 patients were undertaken. At surgery, the average age and BMI of the study group was 58.2 years (range 21 to 76 years) and 27.9 (range 16.3 to 43.4) respectively. Clinical (Harris Hip Score, HHS) and radiological review have been obtained at 6 months, 3 and 5 years. Postal Oxford Hip Score (OHS) and EuroQol- 5D (EQ5D) score have been obtained at 6 months and annually thereafter. To date, 23 study subjects have withdrawn or lost contact, 11 have died, and 9 have undergone revision surgery. By the end of March 2018, 6 month, 1, 2, 3, 4, and 5 year data had been obtained for 511, 445, 427, 376, 296 and 198 subjects respectively.
RESULTS
Implant revision rate is 1.68% (9/535), with revision for any reason as an endpoint; four of the nine involved the revision of the femoral component. At the 5-year time point, mean OHS had improved from 21.3 to 42.5 (p<0.01), EQ5D from 0.42 to 0.82 (p<0.01), and HHS from 51.6 to 92.5 (p<0.01). Radiological analysis is ongoing, and thus far has revealed more variation in stem alignment than is usually observed for more conventional length femoral components. This may indicate that optimal alignment of calcar loading short stems is different to that of longer, medullary canal aligned implants, consistent with the neck-stabilised design of the MiniHip™ stem. No other significant radiological findings were noted.
During surgery, 31 calcar fractures were sustained, of which 20 were treated with cerclage wiring, 1 with femoral grafting and the remainder required no treatment. None of the hips with calcar fractures have been revised to date.
DISCUSSION
The clinical and radiological performance of the MiniHip™ femoral stem is consistent with established femoral implants. Longer surveillance will determine whether this performance is maintained. Patients in this study will be continued to be followed-up and reviewed at the 7 and 10-year time points.
CONCLUSION
The MiniHip™ stem is safe and efficacious at mid-term follow-up.
