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Cormet Post-PMA Study: New Enrollment (PASNew)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722007
First Posted: July 25, 2008
Last Update Posted: July 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Corin
July 23, 2008
July 25, 2008
July 6, 2017
April 24, 2008
April 11, 2014   (Final data collection date for primary outcome measure)
to compare composite clinical success and revisions in the post approval study to the IDE study [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT00722007 on ClinicalTrials.gov Archive Site
  • Harris Hip Score components including total score, pain, function and range of motion [ Time Frame: 24 months ]
  • device survival [ Time Frame: 24 months ]
  • device related adverse events [ Time Frame: 24 months ]
  • radiographic evaluation including radiolucencies, component migration, femoral subsidence and tilt [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
Cormet Post-PMA Study: New Enrollment
Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
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).
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Osteoarthritis
  • Avascular Necrosis
  • Rheumatoid Arthritis
Device: Cormet Hip Resurfacing
Cormet Hip Resurfacing implant
Other Name: Corin Cormet
Experimental: Cormet Hip Resurfacing Post-PMA Group
hip resurfacing
Intervention: Device: Cormet Hip Resurfacing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
May 12, 2014
April 11, 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00722007
Cormet (P050016) New Enroll
Yes
Not Provided
Not Provided
Corin
Corin
Not Provided
Study Director: Kathy Trier Corin
Corin
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP