The impact of local bisphosphonate treatment on prosthetic fixatio
- Conditions
- Osteoarthritis of the hip joint treated with total hip replacement
- Registration Number
- EUCTR2009-014414-98-SE
- Lead Sponsor
- Department of Orthopaedic Surgery University Hospital Linköping
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patients 50-65 years of age with primary osteoarthritis of the hip that are planned for total hip arthroplasty.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Osteoporosis. Treatment with coticosteroids. Treatment with drugs that influence bone metabolism e.g.bisphosphonates, cytostatic drugs, anticonvulsive drugs.
Osteomalacia, malignant disease, bonemetastases, osteogenesis imperfecta, dysplastic fibrosis, hyperparathyroidisim, hyperthyroidism, abnormal kidney function defined as elevated serum-kreatinin. Liver failure. Gastric ulceration within the last year.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To Investigate if local treatment of the bonebed with bisphosphonate solution prior to fixation of the acetabular component of a cemented hip prosthesis decreases the risk for future loosening of the prosthesis.;Secondary Objective: ;Primary end point(s): Local treatment of the acetabular bone bed with bisphosphonate drugs results in less resorption of the periprosthetic bone and consequently in a more stabile fixation.<br><br>End Point: Radiostereometric Analysis at 2 years post surgery.
- Secondary Outcome Measures
Name Time Method