Status:
COMPLETED
A Comparison of Two Total Hip Replacements: Hip Resurfacing System Versus Mallory-Head/Exeter
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Biomet Merck Aps,Horsens, Denmark
Gigtforeningen
Conditions:
Osteoarthrosis
Eligibility:
All Genders
50-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter.
Detailed Description
In Denmark approximately 7000 primary hip replacements are implanted yearly, and the incidence is rising with the increasingly aging population. For older patients, the incidence of later revisions of...
Eligibility Criteria
Inclusion
- Patient with primary hip osteoarthrosis (OA).
- Informed patient consent in writing.
- Sufficient bone density to allow uncemented implantation of an acetabular component.
Exclusion
- Presence of other metal implants.
- Working exposure of chrome, cobalt or molybdenum.
- Ingestion of multivitamin or medication containing chrome, cobalt or molybdenum.
- Kidney disease
- Hip joint dysplasia
- Patients with neuromuscular or vascular disease in the affected leg.
- Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
- Patients with fracture sequelae.
- Female patients of childbearing capacity.
- Sequelae to previous hip joint disorder in childhood
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00116948
Start Date
January 1 2005
End Date
January 1 2012
Last Update
December 5 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Orthopaedic Center, Aarhus University Hospital
Aarhus, Jylland, Denmark, 8000