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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis Avascular Necrosis Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

IDE subjects who received the Cormet Hip Resurfacing device

Cormet Hip Resurfacing System

Intervention Type DEVICE

Cormet Hip Resurfacing System

Interventions

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Cormet Hip Resurfacing System

Intervention Type DEVICE

Other Intervention Names

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Corin Cormet

Eligibility Criteria

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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