Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:
Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.
Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASR hip prosthesis | Active Comparator | DuPuy ASR hip prosthesis |
|
| ReCap hip prosthesis | Active Comparator | Biomet ReCap hip prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASR hip prosthesis | Device | Implantation of resurfacing prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up. | follow with intervals of 1 to 3 years for determination of function and prosthesis survival | 10 year follow up |
Not provided
Not provided
Inclusion Criteria:
ASA I-II,DEXA-scanning:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| arne borgwardt, M.D. | Frederiksberg University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frederiksberg University Hospital | Frederiksberg | Copenhagen | 2000 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ReCap hip prosthesis | Device | Implantation of resurfacing prosthesis |
|
|