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

November 20, 2018 updated by: Corin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Merritt Island, Florida, United States, 32953
        • Space Coast Orthopaedics Ctr.
      • Sarasota, Florida, United States, 34233
        • Kennedy White Orthopedics
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • Good Samaritan Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44113
        • Cleveland Center for Joint Reconstruction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

IDE study subjects at 5 IDE study sites

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
IDE subjects who received the Cormet Hip Resurfacing device
Device: Cormet Hip Resurfacing System
Cormet Hip Resurfacing System
Other Names:
  • Corin Cormet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Harris Hip Score components including total score, pain, function and range of motion
Time Frame: 10 years
10 years
device survival
Time Frame: 10 years
10 years
device related adverse events
Time Frame: 10 years
10 years
radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt
Time Frame: 10 years
10 years
whole blood trace metals and renal function
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corin

Investigators

  • Study Director: Kathy Trier, Ph.D., Corin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAS: IDE subjects

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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