NCT01543230

CoMplete™ Acetabular Hip System

Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Total hip replacement	Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-03-02
• Last updated: 2014-04-08

Locations

6 sites across 1 country: United States