Trials / Completed
CompletedNCT00249054
Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Frederiksberg University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ASR hip prosthesis | Implantation of resurfacing prosthesis |
| DEVICE | ReCap hip prosthesis | Implantation of resurfacing prosthesis |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2012-11-01
- First posted
- 2005-11-07
- Last updated
- 2017-03-24
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00249054. Inclusion in this directory is not an endorsement.