Post PMA-Approval Study: New Enrollment Post PMA-Approval Study Post-approval Study Group (New Enrollment) (PASNew)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Corin
ClinicalTrials.gov Identifier:
NCT00722007
First received: July 23, 2008
Last updated: June 10, 2013
Last verified: June 2013

July 23, 2008
June 10, 2013
April 2008
February 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 ] [ Designated as safety issue: Yes ]
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 ] [ 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 ]
Same as current
Not Provided
Not Provided
 
Post PMA-Approval Study: New Enrollment Post PMA-Approval Study Post-approval Study Group (New Enrollment)
Cormet Resurfacing Hip System Post PMA-Approval Study Post-approval 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
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Avascular Necrosis
  • Rheumatoid Arthritis
Device: Cormet Hip Resurfacing
Cormet Hip Resurfacing implant
Other Name: Corin Cormet
Experimental: 1
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.
 
Active, not recruiting
160
February 2014
February 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).
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00722007
Cormet (P050016) New Enroll
Yes
Corin
Corin
Not Provided
Study Director: Yassaman Najmabadi, BS CRA II Corin
Corin
June 2013

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