Prospective Clinical Evaluation of ASR Resurfacing Arthroplasty
This trial is active, not recruiting.
|Condition||patients suitable for tha|
|Sponsor||Frederiksberg University Hospital|
|Trial identifier||NCT00249054, KF11279577|
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: Streght, gait analysis, range of motion. Scanning: DEXA and MRI
|Intervention model||single group assignment|
Male or female participants at least 18 years old.
- lower limit for a 55 years old women,
- MRI normal
- vitality in caput
- willing to return for follow-up evaluations.
- collum femoris < 2 cm
- large cysts in caput (> 1 cm)
- mismatch between caput and acetabulum
- caput necrosis
- treatment with medicine which affects bone metabolism
- impaired kidney function.
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