Osteoarthritis Clinical Trial
Official title:
Prospective Clinical Study Using Radiostereometric Analysis (RSA) and DEXA to Evaluate Fixation and Wear of the Restoration ADM Acetabular System
Verified date | August 2021 |
Source | Dalhousie University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The dual mobility design concept for acetabular liners, as is used in the Restoration ADM Acetabular System, has been applied in various implants since its introduction by Gilles Bousquet in France in 1976. Dual mobility cups have shown good clinical results and have been particularly lauded for low incidence of dislocations. However, the wear performance of this design concept has not been proven to date. As wear particles are a possible contributing factor in aseptic loosening, the assessment of wear and fixation is an important step in proving this implant design. The proposed study will combine RSA and peri-prosthetic bone mineral density as well as outcome questionnaires to provide a complete in vivo evaluation of prosthesis fixation, polyethylene wear, and objective and subjective outcomes for the Restoration ADM Acetabular System.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2019 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty 2. Between the ages of 21 and 80 inclusive 3. Patients willing and able to comply with follow-up requirements and self-evaluations 4. Ability to give informed consent Exclusion Criteria: 1. Inflammatory arthritis 2. BMI >40 3. Post-traumatic arthritis of the hip 4. Prior arthroplasty with the affected hip 5. Hip dysplasia 6. Active or prior infection 7. Medical condition precluding major surgery 8. Severe osteoporosis or osteopenia |
Country | Name | City | State |
---|---|---|---|
Canada | Capital District Health Authority | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Dalhousie University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RSA migration | 3 years | ||
Secondary | RSA wear | 3 years | ||
Secondary | Questionnaires | 3 years |
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