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

Rheumatoid Arthritis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Collagen Diseases
• Collagen Disorders
• Congenital Hip Dysplasia
• Femoral Fractures
• Fractures, Bone
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Nonunion of Femoral Fractures
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Slipped Capital Femoral Epiphyses
• Slipped Capital Femoral Epiphysis
• Traumatic Femoral Fractures

• NCT number: NCT00208364
• Study type: Interventional
• Source: DePuy International
• Status: Terminated
• Phase: Phase 4
• Start date: April 2004
• Completion date: September 2016