NCT00872573

A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement

Prospective, Uncontrolled, Two-centre, RSA, Post-market Surveillance Study to Evaluate the Stability of the C-Stem™ AMT Femoral Component in Primary Total Hip Arthroplasty.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh bone when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical, standard x-ray assessments and special x-rays which allow the stability of the implant to be determined.

Conditions

• Rheumatoid Arthritis
• Osteoarthritis
• Post-traumatic Arthritis
• Collagen Disorders
• Avascular Necrosis
• Traumatic Femoral Fractures
• Nonunion of Femoral Fractures
• Congenital Hip Dysplasia
• Slipped Capital Femoral Epiphysis

Interventions

Type	Name	Description
DEVICE	C-Stem™ AMT Femoral Component (standard and high off-set variants)	A polished triple tapered cemented femoral component for use in total hip replacement

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2009-03-31
• Last updated: 2017-06-26

Locations

1 site across 1 country: United Kingdom