Trials / Completed
CompletedNCT00253877
A Comparison of a Resurfacing Hip System to Standard Total Hip Arthroplasty
A Prospective, Multi-Centre, Historical Control Trial Comparing the Conserve® Plus Resurfacing Hip System to Standard Total Hip Arthroplasty.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Ottawa Hospital Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study compares outcomes and metal ion levels between patients who receive the Conserve® Plus Hip System compared to those who have received a standard hip replacement in a recent study.
Detailed description
Total hip arthroplasty (THA) is currently the standard of care for end-stage degenerative joint disease of the hip. In this surgery, the entire joint is replaced by inserting an acetabular component into the pelvis, a femoral stem down the thigh bone (which has a ball on it to articulate in the acetabulum). However for the younger patient, long-term fixation and the prospect of multiple revisions remain a notable concern. Long-term results of THA in this patient population have been disappointing. Studies cite failure rates of 21% to 33% at less than 10 years follow up. The Conserve Plus Hip System differs from total hip arthroplasty as it uses less bone stock from the femoral bone. The prosthesis is designed so that the head of the femoral bone is resurfaced rather than replaced. Consequently, bone stock of the femur is conserved. The bone conserving nature of this implant allows the surgeon to convert to a total hip arthroplasty with ease should a time arise when the patient requires revision arthroplasty. The Conserve Plus Hip System is also different from the THA as the bearing surface is metal on metal, rather than the conventional metal on polyethylene. This metal on metal bearing surface provides lower wear. Theoretically, this type of hip replacement may be a viable alternative to THA for the younger patient.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Complication rate | All patients in the active comparator group received the Conserve Plus Hip Resurfacing System, manufactured by Wright Medical Technology. The complication rate and clinical efficacy will be recorded and compared to the Total Hip Replacement historical control group. |
Timeline
- Start date
- 2003-07-01
- Primary completion
- 2010-05-01
- Completion
- 2010-05-01
- First posted
- 2005-11-15
- Last updated
- 2020-03-10
Locations
3 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00253877. Inclusion in this directory is not an endorsement.