Intra-operative Clodronate Rinsing Improves the Integration of the Femoral Stem in a Prospective, Double-blinded, Randomized, Placebo-controlled Clinical RSA-study

Abstract

Background: Periprosthetic bone loss after Total Hip Arthroplasty (THA), detected as an early migration of the prosthesis may predict later loosening of the implant. Objective: We hypothesized that intra-operative bisphosphonate rinsing would reduce bone resorption after THA. It might therefore be possible to achieve better early fixation of the implant. Methods: Nineteen patients suffering from arthrosis were recruited in a prospective, double-blinded, randomized, placebo-controlled clinical pilot trial. Patients were operated with an uncemented Bimetric stem using tantalum markers. The femoral proximal intramedullary canal was rinsed with 1mM clodronate in nine patients and with saline in 10 patients. These patients were followed for two years using radiostereometric analysis (RSA), dual energy x-ray absorptiometry (DXA) and the Harris Hip Score (HHS). Results: We did not found any significant differences between the study groups with regards to the primary output measures (maximum total point motion, MTPM). However, there was evidence that clodronate could affect periprosthetic bone quality; a beneficial effect in BMD in Gruen zone 3 during the two-year follow-up was observed, BMD decreased less in the clodronate group (p = 0.02). The maximal x-translation of the stem at 3-24 months was significantly two-fold, being higher in the placebo group (p = 0.02). The baseline BMD and the maximal total point motion (MTPM) at 3-24 months showed a positive correlation in the clodronate group and a negative correlation in the placebo group. Conclusion: In conclusion, further studies with larger patient groups and longer follow-up periods are needed to estimate the clinical importance of these findings and further to prove if an intraoperative clodronate rinsing prior to application of femoral stem during THA can prevent periprosthetic bone loss. Clinical Trial Registration No.: NCT03803839