CoMplete™ Acetabular Hip System

Stopped early · Not applicable

Conditions studied: Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Post-traumatic Arthritis

In brief

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.

Key facts

Study ID

NCT01543230

Run by

DePuy Orthopaedics

People needed

58

Starts

2012-02-01

Expected to finish

2013-10-01

Last updated by the study team

2014-04-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. If the subject:
• Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
• Qualifies based on the approved labeling for the device; and
• 2. Is willing and able to provide informed patient consent for participation in the PAS study; and
• 3. Is willing and able to return for follow-up as specified by the PAS study protocol; and
• 4. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has
• consented to participate,
• authorized release of Personal Health Information (PHI),
• met all eligibility criteria through the operative stage, and
• received the implant as noted in this protocol.

You may not qualify if…

• Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.

Where it is running

• Hip and Knee Arkansas Foundation — Little Rock, Arkansas, United States
• Orthopaedic Specialty Institute — Orange, California, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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