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
  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)

Resource links provided by NLM:


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 ]

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
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

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
Sponsors and Collaborators
Corin
Investigators
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: June 10, 2013
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 April 15, 2014