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

Large Diameter Metal-on-Metal Total Hip System IDE

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.

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.

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.