This trial is active, not recruiting.

Condition patients suitable for tha
Treatment asr (tha)
Phase phase 4
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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

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.

Trial information was received from ClinicalTrials.gov and was last updated in July 2007.
Information provided to ClinicalTrials.gov by Frederiksberg University Hospital.