Back to resultsCormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Large Diameter Metal on Metal
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring arthritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Large Diameter Metal on Metal
Arm Description
Outcomes
Primary Outcome Measures
Composite clinical criterion
Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00867256
Brief Title
Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)
Official Title
Large Diameter Metal-on-Metal Total Hip System IDE
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
terminated for business reasons; study closed.
Study Start Date
March 31, 2004 (Actual)
Primary Completion Date
October 23, 2006 (Actual)
Study Completion Date
April 27, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
Keywords
arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Large Diameter Metal on Metal
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Large Diameter Metal on Metal
Primary Outcome Measure Information:
Title
Composite clinical criterion
Description
Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component
Time Frame
24-months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulia Carli
Organizational Affiliation
Corin Ltd
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)
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