Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253877
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2005-11-10
Brief Title:
A Comparison of a Resurfacing Hip System to Standard Total Hip Arthroplasty
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
A Prospective Multi-Centre Historical Control Trial Comparing the Conserve Plus Resurfacing Hip System to Standard Total Hip Arthroplasty
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None