Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects (PAS:IDE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Corin
ClinicalTrials.gov Identifier:
NCT00721994
First received: July 23, 2008
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.


Condition Intervention
Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Device: Cormet Hip Resurfacing System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan

Resource links provided by NLM:


Further study details as provided by Corin:

Primary Outcome Measures:
  • to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Harris Hip Score components including total score, pain, function and range of motion [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • device survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • device related adverse events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • whole blood trace metals and renal function [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

blood specimens for metal ion testing and renal function testing


Estimated Enrollment: 350
Study Start Date: May 2008
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
IDE subjects who received the Cormet Hip Resurfacing device
Device: Cormet Hip Resurfacing System
Cormet Hip Resurfacing System
Other Name: Corin Cormet

Detailed Description:

Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

IDE study subjects at 5 IDE study sites

Criteria

Inclusion Criteria:

  • subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
  • Individuals who agree to participate in the study by signing the informed patient consent form

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721994

Locations
United States, Florida
Space Coast Orthopaedics Ctr.
Merritt Island, Florida, United States, 32953
Kennedy White Orthopedics
Sarasota, Florida, United States, 34233
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Maryland
Good Samaritan Hospital
Baltimore, Maryland, United States, 21239
United States, Ohio
Cleveland Center for Joint Reconstruction
Cleveland, Ohio, United States, 44113
Sponsors and Collaborators
Corin
Investigators
Study Director: Yassaman Najmabadi, BS CRA Corin
  More Information

No publications provided

Responsible Party: Corin
ClinicalTrials.gov Identifier: NCT00721994     History of Changes
Other Study ID Numbers: PAS: IDE subjects
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
Osteoarthritis
Necrosis
Osteonecrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on October 19, 2014