NCT00867256

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

Large Diameter Metal-on-Metal Total Hip System IDE

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Avascular Necrosis

Interventions

Type	Name	Description
DEVICE	Large Diameter Metal on Metal

Timeline

• Start date: 2004-03-31
• Primary completion: 2006-10-23
• Completion: 2009-04-27
• First posted: 2009-03-23
• Last updated: 2023-09-22

Regulatory

• FDA-regulated device study