Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Post PMA-Approval Study: New Enrollment Post PMA-Approval Study Post-Approval Study Group (New Enrollment) (PASNew)
This study is currently recruiting participants.
Verified by Corin, July 2008
Sponsored by: Corin
Information provided by: Corin
ClinicalTrials.gov Identifier: NCT00722007
  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 IV

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Cormet Resurfacing Hip System Post PMA-Approval Study Post-Approval Study Group (New Enrollment)

Further study details as provided by Corin:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
hip resurfacing
Device: Cormet Hip Resurfacing
Cormet Hip Resurfacing implant

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
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722007

Contacts
Contact: Yassaman Najmabadi, BS CRA 813-977-4469 yassaman.najmabadi@coringroup.com

Locations
United States, District of Columbia
George Washington University Recruiting
Washington DC, District of Columbia, United States, 20006
Contact: Lucy     202-466-5151     lucy@wosm.com    
Principal Investigator: Anthony Unger, MD            
United States, Texas
Memorial Bone & Joint Recruiting
Houston, Texas, United States, 77024
Contact: Elizabeth     713-827-9316     ehernandez@mbjc.net    
Principal Investigator: Stefan Kreuzer, MD            
Sponsors and Collaborators
Corin
Investigators
Study Director: Yassaman Najmabadi, BS CRA Corin
  More Information

Responsible Party: Corin USA ( Kathy Trier )
Study ID Numbers: Cormet (P050016) New Enroll
Study First Received: July 23, 2008
Last Updated: July 24, 2008
ClinicalTrials.gov Identifier: NCT00722007  
Health Authority: United States: Institutional Review Board

Keywords provided by Corin:
hip resurfacing
osteoarthritis
avascular necrosis
rheumatoid arthritis

Study placed in the following topic categories:
Necrosis
Autoimmune Diseases
Musculoskeletal Diseases
Osteonecrosis
Osteoarthritis
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases

Additional relevant MeSH terms:
Pathologic Processes
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009