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.
Inclusion Criteria: ASA I-II,DEXA-scanning: - lower limit for a 55 years old women, - MRI normal - vitality in caput - willing to return for follow-up evaluations. Exclusion Criteria: - 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.
Call for more information