Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
195 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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