Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing Arthroplasty

Bearings Clinical Trial

Official title:

Prospective Clinical Evaluation of ASR/Re-Cap Resurfacing Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376610
• Other study ID #: KF1127957
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2006
• Last updated: July 3, 2007

Study information

• Verified date: July 2007
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: De Videnskabsetiske Komit'eer for Københavns og Frederiksberg Kommune
• Study type: Interventional

Clinical Trial Summary

ASR/Re-cap versus 28 MoM

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of THA

• ASA I-II

• Willing to return for follow-up evaluations

Exclusion Criteria:

• Collum femurs < 2 cm

• Cysts > 1 cm

• Caput necrose

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bearings

Intervention

Device:
• ASR/Re-cap

Locations

Country	Name	City	State
Denmark	Frederiksberg University Hospital	Frederiksberg	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark,