Status:
TERMINATED
Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)
Lead Sponsor:
Corin
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
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 endp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 31 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2009
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00867256
Start Date
March 31 2004
End Date
April 27 2009
Last Update
September 22 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.