NCT00208390

A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement

Prospective, Uncontrolled, Multi-Centre, Post-Marketing Surveillance Study to Evaluate the Long-Term Performance of Summit Tapered Hip in Cementless Total Hip Arthroplasty

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to monitor the performance of the Summit™ hip 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 and x-ray assessments.

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	Summit Tapered Hip System	A cementless, tapered femoral component for use in total hip replacement

Timeline

• Start date: 2003-02-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2005-09-21
• Last updated: 2016-08-04

Locations

5 sites across 5 countries: China, Hong Kong, Italy, New Zealand, South Korea