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

NCT ID: NCT00867256

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2009-04-27

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Large Diameter Metal on Metal

Group Type: EXPERIMENTAL

Large Diameter Metal on Metal

Intervention Type: DEVICE

Interventions

Large Diameter Metal on Metal

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Patient:

• is skeletally mature
• is mentally capable of completing follow-up forms
• will be available for follow-up out to 2 years
• has a preoperative Harris Hip Score <70 points
• has been deemed a candidate for hip replacement by diagnosis of the investigator.

Exclusion Criteria

Patient:

• has active joint infection
• has had previous hip arthrodesis (fusion)
• has had above knee amputation of either extremity
• has active neoplastic disease
• has a need for a structural bone graft in the operative side
• has an ipsilateral hemi or total arthroplasty of any kind
• has a nonunion or malunion of any part of the femur on operative side
• has severe osteoporosis of the pelvis and/or femur as noted on standard radiograph
• is a prisoner
• is pregnant
• is known to be allergic to implant materials
• is morbidly obese.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giulia Carli

Role: STUDY_DIRECTOR

Corin Ltd

Other Identifiers

LDMOM

Identifier Type: -

Identifier Source: org_study_id