At a glance
ClinicalIndex Comparison Record- ✓Skeletally mature with closed tibial and femoral epiphyses
- ✓Undergoing cementless primary hip replacement for non-inflammatory degenerative joint disease
- ✓Affected hip has Harris Hip Score ≤70 and Pain rating Moderate or greater
- ✓X-ray confirms non-inflammatory degenerative joint disease
- ✕Bilateral hip disease with anticipated need for bilateral hip implant within 24 months
- ✕Hip replacement required for revision of previously failed hip replacement
- ✕Inflammatory arthritis
- ✕Prior prosthetic hip replacement
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparative Study to Evaluate the Safety and Efficacy of the DePuy Ceramic-on-metal Total Hip Prosthesis Versus the DePuy Metal-on-metal Total Hip Prosthesis Through Clinical and Radiographical Data
In Brief
A clinical study evaluating Total Hip Replacement and Total hip replacement for Non-inflammatory Joint Diseases. Completed, enrolled 392 participants across 9 sites in 2 countries.
Detailed Summary
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components. The success of the total hip arthroplasty (THA) will be based upon all of the following clinical and radiographic criteria being met at the two-year evaluation: (1) the patient's clinical results as measured using modified Harris Hip evaluation rating system, and the absence of a complication that requires the surgical removal or replacement of a component; and (2) radiographic findings at study endpoint (i.e., two years follow-up). Clinical and radiographic success at two (2) years postoperative is required for the study hip to be deemed successful.
Study Details
Timeline
Interventions
Total hip replacement
Total hip replacement