NCT00208364

A Two Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Metal-on-Metal Bearing in Primary Total Hip Replacement

Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 163 (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 and determine the metal ion release of the Pinnacle™ Cup with a metal-on-metal bearing combination 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. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels 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	Pinnacle Acetabular Cup System	A cementless acetabular cup with metal liner for use in total hip replacement

Timeline

• Start date: 2004-04-01
• Primary completion: 2014-10-01
• Completion: 2016-09-01
• First posted: 2005-09-21
• Last updated: 2016-10-07

Locations

2 sites across 2 countries: Italy, United Kingdom