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

Rheumatoid Arthritis Clinical Trial

— PAS:IDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721994
• Other study ID #: PAS: IDE subjects
• Status: Completed
• Start date: May 2008
• Est. completion date: August 2017

Study information

• Verified date: November 2018
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Osteonecrosis
• Rheumatoid Arthritis

Intervention

Device:
• Cormet Hip Resurfacing System
Cormet Hip Resurfacing System

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Baltimore	Maryland
United States	Cleveland Center for Joint Reconstruction	Cleveland	Ohio
United States	Space Coast Orthopaedics Ctr.	Merritt Island	Florida
United States	Kennedy White Orthopedics	Sarasota	Florida
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		10 years
Secondary	Harris Hip Score components including total score, pain, function and range of motion		10 years
Secondary	device survival		10 years
Secondary	device related adverse events		10 years
Secondary	radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt		10 years
Secondary	whole blood trace metals and renal function		10 years