Clinical trial NCT00722007: Cormet Post-PMA Study: New Enrollment
Official title: Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Keywords: hip resurfacing
osteoarthritis
avascular necrosis
rheumatoid arthritis
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2008-07-25
Enrollment: 147
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

Detailed description: This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).

Eligibility criteria: Inclusion Criteria:

* Male or female patient who meets eligibility criteria consistent with product labeling
* skeletally mature
* mentally capable of completing follow-up forms
* Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation
* Has been deemed a candidate for hip replacement by diagnosis of the investigator
* consented to participate in the clinical study

Exclusion Criteria:

* Patient with active or suspected infection in or around the hip joint;
* Patient with bone stock inadequate to support the device
* Patient with severe osteopenia
* Patient with a family history of severe osteoporosis or severe osteopenia;
* Patient with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT Grade)
* Patient with multiple cysts of the femoral head (\>1cm)
* In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
* Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery;
* Female of child-bearing age due to unknown effects on the fetus of metal ion release.
* Patient with known moderate or severe renal insufficiency;
* Patient who is immunosuppressed with diseases such as AIDS or person receiving high doses of corticosteroids;
* Patient who is severely overweight;
* Patient with known or suspected metal sensitivity (e.g., jewelry).

Primary outcomes:
measure: The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
timeFrame: Month 24+
Secondary outcomes:
measure: Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+
timeFrame: Month 24+
measure: Survival Rate Using Kaplan-Meier Survival Curves
timeFrame: Month 24+
measure: Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events
timeFrame: Month 24+
measure: The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively
timeFrame: Month 24+
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Rochester
country: United States
facility: Lattimore Orthopaedics P.C.
state: New York
city: Salem
country: United States
facility: Willamette Orthopedic Group LLC
state: Oregon
city: Houston
country: United States
facility: Memorial Bone and Joint Clinic
state: Texas
Study officials:
References: