A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery
- Conditions
- Primary ArthritisSecondary Arthritis
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 89
- 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.
- 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
- 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)
Sygehus Sønderjyllands
🇩🇰Sønderborg, Denmark
Orthopädie Kupfalz
🇩🇪Speyer, Germany
Orthopaedic Clinic University La Sapienza
🇮🇹Rome, Italy
Hospital Nisa Sevilla-Aljarafe
🇪🇸Sevilla, Spain
Hospital San Juan de Dios del Aljarafe
🇪🇸Sevilla, Spain
Hospital Santa Ángela De La Cruz
🇪🇸Sevilla, Spain
Princess Alexandra Hospital
🇬🇧Harlow, Essex, United Kingdom
The Rivers Hospital
🇬🇧Sawbridgeworth, Hertfordshire, United Kingdom
Wrightington Hospital
🇬🇧Wrightington, Lancashire, United Kingdom
Sygehus Sønderjyllands🇩🇰Sønderborg, Denmark