Post PMA-Approval Study: New Enrollment Post PMA-Approval Study Post-approval Study Group (New Enrollment) (PASNew)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis |
Device: Cormet Hip Resurfacing |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cormet Resurfacing Hip System Post PMA-Approval Study Post-approval Study Group (New Enrollment) |
- to compare composite clinical success and revisions in the post approval study to the IDE study [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Harris Hip Score components including total score, pain, function and range of motion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- device survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- device related adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- radiographic evaluation including radiolucencies, component migration, femoral subsidence and tilt [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
hip resurfacing
|
Device: Cormet Hip Resurfacing
Cormet Hip Resurfacing implant
Other Name: Corin Cormet
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations| United States, District of Columbia | |
| George Washington University | |
| Washington DC, District of Columbia, United States, 20006 | |
| United States, Florida | |
| Florida Orthopaedic Institute | |
| Tampa, Florida, United States, 33637 | |
| United States, Maryland | |
| Sinai Hospital of Baltimore | |
| Baltimore, Maryland, United States, 21215 | |
| United States, New York | |
| Lattimore Orthopaedics P.C. | |
| Rochester, New York, United States, 14620 | |
| United States, Oregon | |
| Willamette Orthopedic Group LLC | |
| Salem, Oregon, United States, 97301 | |
| United States, Texas | |
| Memorial Bone and Joint Clinic | |
| Houston, Texas, United States, 77043 | |
| Study Director: | Yassaman Najmabadi, BS CRA II | Corin |
More Information
No publications provided
| Responsible Party: | Corin |
| ClinicalTrials.gov Identifier: | NCT00722007 History of Changes |
| Other Study ID Numbers: | Cormet (P050016) New Enroll |
| Study First Received: | July 23, 2008 |
| Last Updated: | July 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Corin:
|
hip resurfacing osteoarthritis avascular necrosis rheumatoid arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Necrosis Osteonecrosis Osteoarthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on May 23, 2013