NCT00878046

Multi-centre Study to Assess Long-term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary THR

A Non-comparative, Multi-centre Study to Evaluate the Safety and Efficacy of the DePuy Silent™ Hip Prosthesis in Primary Total Hip Replacement

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: DePuy International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the Silent™ hip is effective 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 undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

Detailed description

The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is effective 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 undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	DePuy Silent™ Hip femoral prosthesis	A short cementless, femoral component for use in total hip arthroplasty

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-03-01
• Completion: 2014-11-01
• First posted: 2009-04-08
• Last updated: 2016-04-21

Locations

7 sites across 5 countries: Australia, France, Germany, Italy, United Kingdom