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

Corin

Status: Completed

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Treatments: Device: Cormet Hip Resurfacing System

Study type: Observational

Funder types: Industry

Identifiers

NCT00721994

PAS: IDE subjects

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

231 participants in 1 patient group

1

Description:

IDE subjects who received the Cormet Hip Resurfacing device

Treatment:

Device: Cormet Hip Resurfacing System