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

Not Applicable

Terminated

• Conditions: Primary Arthritis; Secondary Arthritis
• Interventions: Device: Silent™ Hip

• Registration Number: NCT01383824
• Lead Sponsor: DePuy International

Brief Summary

The purpose of this study is to monitor the performance and of the Silent 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2013-07
• Status Verified: 2014-08
• Study Completion: 2015-07
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study.

Exclusion Criteria

• Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silent™ Hip	Silent™ Hip	A short cementless, femoral component for use in total hip arthroplasty

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship	5 years post-surgery

Secondary Outcome Measures

Name	Time	Method
University of California Los Angeles (UCLA) Activity Score	15 years
Radiographic analysis	15 Years
Oxford Hip Score	15 Years
EuroQol EQ-5D	15 Years
Harris Hip Score	15 Years

Trial Locations

Locations (9)

Hospital San Juan de Dios del Aljarafe; 🇪🇸 Sevilla, Spain

Orthopädie Kupfalz; 🇩🇪 Speyer, Germany

Hospital Santa Ángela De La Cruz; 🇪🇸 Sevilla, Spain

Hospital Nisa Sevilla-Aljarafe; 🇪🇸 Sevilla, Spain

The Rivers Hospital; 🇬🇧 Sawbridgeworth, Hertfordshire, United Kingdom

Sygehus Sønderjyllands; 🇩🇰 Sønderborg, Denmark

Orthopaedic Clinic University La Sapienza; 🇮🇹 Rome, Italy

Princess Alexandra Hospital; 🇬🇧 Harlow, Essex, United Kingdom

Wrightington Hospital; 🇬🇧 Wrightington, Lancashire, United Kingdom