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Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System
The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.
This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Hip and Knee Arkansas Foundation
Little Rock, Arkansas, United States
Orthopaedic Specialty Institute
Orange, California, United States
Fort Collins, Colorado, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Seattle, Washington, United States
Start Date
February 1, 2012
Primary Completion Date
October 1, 2013
Completion Date
October 1, 2013
Last Updated
April 8, 2014
58
ACTUAL participants
Total hip replacement
DEVICE
Lead Sponsor
DePuy Orthopaedics
NCT07153471
NCT07351968
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06381791