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

Jukka Kiuttu,Maarit Valkealahti,Pasi Ohtonen,Petri Lehenkari,Olli Yrjämä,Hannu-Ville Leskelä

doi:10.2174/1874325002115010001

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

Highlights

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 Total Hip Arthroplasty (THA) can prevent periprosthetic bone loss
We have proved in an earlier experimental study that a 1 minute incubation time is sufficient for the almost total binding of bisphosphonate onto the bone surface and a 1 mM concentration causes a sufficient reduction in bone resorption and osteoclast apoptosis rate [9]
We evaluated the differences in Bone Mineral Density (BMD) between study groups in each Gruen zone during 0-24 months

Summary

Introduction

There appear to be three factors involved in the etiology of aseptic prosthesis loosening. Oscillating fluid pressure at the bone-implant interface may lead to osteolysis [4 - 6]. Bisphosphonates have a strong, long-lasting and wellestablished inhibitory effects on bone resorption. Clodronate, an early bisphosphonate, is a non-amino compound, which in contrast to amino bisphosphonates, has anti-inflammatory [11] and analgesic effects [12], making it favorable for the prevention of aseptic loosening after THA [13]. Periprosthetic bone loss after Total Hip Arthroplasty (THA), detected as an early migration of the prosthesis may predict later loosening of the implant

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Results

Discussion

Conclusion