Aseptic Loosening of the Hip Prosthesis Clinical Trial
Official title:
Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-blind Study in Patients Operated for Aseptic Loosening and Osteolysis.
The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.
Morsellized compacted bone allograft can be used for revision arthroplasty of the hip.
Treating the graft locally with an antiresorptive substance such as a bisphosphonate has
decreased the graft resorption in animal studies and led to a remained bone density in a
human series of 16 patients. In the present study we investigate if this increased bone
density of the graft also causes a decreased micromotion of the implant relative the femur.
36 patients are planned to participate in a 1:1 randomized and prospective study comparing
the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first
year but also secondary parameters such as late micromotion (between 12 and 24 months),
re-loosening subjective outcome and safety.
We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption
and therefore may reduce the risk of mechanical failure. Patients are followed with
radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and
subjective months and subjective parameters including Womac and SF 12. The treatment is
simple, cheap and appears virtually risk-free.
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