Osteoarthritis Clinical Trial
Official title:
A Randomized Controlled Trial Utilizing RSA for a Comparison of Minimally Invasive Surgery (MIS) vs. Standard Exposure in Primary Total Hip Arthroplasty With the ProfemurZ Modular Femoral Stem
Verified date | January 2019 |
Source | Dalhousie University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 2019 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Subjects are under the age of 65 years - Subjects have not had hip replacement surgery on the affected hip - Subjects have decided to undergo a primary total hip replacement of the affected hip Exclusion Criteria: - Having a previous hip infection - Undergoing surgery for arthritis due to a previous injury, rheumatoid arthritis or hip dysplasia (a hip that did not develop completely) |
Country | Name | City | State |
---|---|---|---|
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Dalhousie University | Wright Medical Technology |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The purpose of this study is to determine if MIS for primary hip replacement surgery increases the risk of long term aseptic loosening as predicted by implant micromotion detected by radiostereometric analysis | 2 years |
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