CoMplete™ Acetabular Hip System

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Joint Diseases
Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Post-traumatic Arthritis

Clinical Trial Details

NCT number	NCT01543230
Study type	Interventional
Source	DePuy Orthopaedics
Contact
Status	Terminated
Phase	N/A
Start date	February 2012
Completion date	October 2013

View Details

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