Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects - Full Text View

Sponsor:	Corin
Information provided by:	Corin
ClinicalTrials.gov Identifier:	NCT00721994

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:	Cohort, 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:

MedlinePlus related topics: Osteoarthritis Osteonecrosis Rheumatoid Arthritis

U.S. FDA Resources

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

Biospecimen Description:

blood specimens for metal ion testing and renal function testing

Estimated Enrollment:	450
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

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

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 USA ( Kathy Trier, Ph.D. )
Study ID Numbers:	PAS: IDE subjects
Study First Received:	July 23, 2008
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00721994 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Corin:

hip resurfacing
osteoarthritis
avascular necrosis
rheumatoid arthritis

Additional relevant MeSH terms:

Autoimmune Diseases
Osteonecrosis
Immune System Diseases
Osteoarthritis
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Bone Diseases
Necrosis
Pathologic Processes
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on February 08, 2010