Locally Administered Clodronate in the Prevention of Aseptic Implant Loosening
Status:
Completed
Trial end date:
2014-03-12
Target enrollment:
Participant gender:
Summary
Periprosthetic bone-loss after total hip arthroplasty (THA), detected as an early migration
of the prosthesis, may predict later loosening. The investigators hypothesized that by
reducing bone resorption after THA with bisphosphonates, it might be possible to achieve
better early fixation of the implant.
Nineteen patients suffering arthrosis were recruited to a prospective, double-blinded,
randomized, placebo-controlled clinical pilot trial. Patients were operated with an
uncemented Bimetric stem with tantalum markers, the acetabular cup and liner were chosen by
the surgeon. The femoral proximal intramedullary canal was rinsed with 1mM (millimole)
clodronate, that was done by adding the clodronate to the 1000 ml 0.9% NaCl (sodium chloride)
in nine patients and rinsing solution was the pure 0.9% NaCl for 10 patients. These rinsing
packages were labeled only with the code from the pharmacy of the hospital. These patients
were followed for two years using radiostereometric analysis (RSA), dual energy x-ray
absorptiometry (DXA) and the Harris hip score (HHS).
The purpose of the investigator's study was to examine whether the local intraoperative
administration of clodronate could reduce periprosthetic bone loss and further stem migration
after primary THA.