Overview

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

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: 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.