Osteoarthritis, Hip Clinical Trial
Official title:
Uncemented Total Hip Implant and Subcutaneous Injections of Denosumab for Patients With Osteoarthritis of the Hip. A Randomized Double Blind Placebo Controlled Study on the Effects on Bone Evaluated With DXA, PET/CT and Biochemical Markers
The primary objective is to study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The primary hypothesis is to demonstrate that Denosumab is superior to placebo.
A clinical study with 64 patients, age 35-65 years, with unilateral osteoarthritis of the
hip, randomised to two groups of patients, either receiving Denosumab or placebo
The patients will operated with an uncemented total hip arthroplasty with a Continuum
acetabular cup with trabecular surface (Tantalum) and longevity Highly Cross-linked
Polyethylene liner, Zimmer, Warsaw, IN, USA, and a CFP femoral stem with Titanium surface
and a chrome cobalt 28 mm head, Waldemar Link, Hamburg, Germany.
Clinical outcome evaluated by Harris Hip Score and EQ-5D, Bone Mineral Density by DXA,
Standardised Uptake Value of Fluoride tracer, by PET/CT and biochemical markers for bone
formation and bone resorption will be analyzed together with conventional radiology for
implant position and fixation.
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