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Completed

NCT Number: NCT00721994

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

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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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Space Coast Orthopaedics Ctr., Merritt Island, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cormet Hip Resurfacing System

Device

Cormet Hip Resurfacing System

Other names: Corin Cormet

Primary outcomes

  1. 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

Secondary outcomes

  1. Harris Hip Score components including total score, pain, function and range of motion

    Time frame: 10 years

  2. device survival

    Time frame: 10 years

  3. device related adverse events

    Time frame: 10 years

  4. radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt

    Time frame: 10 years

  5. whole blood trace metals and renal function

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Corin

Industry

Registry information

Official study 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

Acronym: PAS:IDE

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Jul 25, 2008
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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