Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty

Not Applicable

Completed

• Conditions: Patients Suitable for THA

• Registration Number: NCT00249054
• Lead Sponsor: Frederiksberg University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-03
• Study First Submitted QC: 2005-11-04
• Study First Posted: 2005-11-07
• Primary Completion: 2012-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.	10 year follow up	follow with intervals of 1 to 3 years for determination of function and prosthesis survival

Trial Locations

Locations (1)

Frederiksberg University Hospital; 🇩🇰 Frederiksberg, Copenhagen, Denmark