Study to Assess the Stability, Efficacy and Safety of the Silent™ Hip Prosthesis in Primary Total Hip Replacement

Osteoarthritis Clinical Trial

Official title: A Non-comparative, Two Centre, EN540, RSA, Pilot Study to Evaluate the Stability, Efficacy and Safety of the Silent Hip Prosthesis in Primary Total Hip Replacement

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is stable and effective in treatment of patients with 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 and special x-rays (RSA) to allow the position of the Silent Hip within the bone to be accurately monitored.

Clinical Trial Description

The Primary Objective of this study was to evaluate the short-term stability of the Silent Hip, implanted using a manual or navigated technique, using radiostereometric analysis (RSA). The study was also intended to provide the clinical data necessary to demonstrate conformance with the essential requirements of the Medical Device Directive. Secondary objectives were to determine the efficacy of the Silent™ Hip femoral prosthesis from a clinical and radiological prospective, to assess the safety of the device and to evaluate the impact of the procedure on the Subjects' Quality of Life. ;

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis

• NCT number: NCT00894140
• Study type: Interventional
• Source: DePuy International
• Status: Completed
• Phase: N/A
• Start date: January 2003
• Completion date: May 2014