Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis; Avascular Necrosis; Osteoarthritis
• Interventions: Device: Large Diameter Metal on Metal

• Registration Number: NCT00867256
• Lead Sponsor: Corin

Brief Summary

To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.

Detailed Description

The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.

Study Timeline

• Study Start: 2004-03-31
• Primary Completion: 2006-10-23
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2009-03-19
• Study First Posted: 2009-03-23
• Study Completion: 2009-04-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Large Diameter Metal on Metal	Large Diameter Metal on Metal	-

Primary Outcome Measures

Name	Time	Method
Composite clinical criterion	24-months postoperative	Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component