CoMplete™ Acetabular Hip System

DePuy Synthes

Status

Terminated

Conditions

Non-inflammatory Degenerative Joint Disease

Osteoarthritis

Post-traumatic Arthritis

Treatments

Device: Total hip replacement

Study type

Interventional

Funder types

Industry

Identifiers

NCT01543230

09014

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. If the subject:
2. Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
3. Qualifies based on the approved labeling for the device; and
1. Is willing and able to provide informed patient consent for participation in the PAS study; and
1. Is willing and able to return for follow-up as specified by the PAS study protocol; and
1. 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.

Exclusion criteria

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.