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

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the Silent™ Hip in Subjects Requiring a Total Hip Replacement

Conditions
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Primary Arthritis, Secondary Arthritis

Intervention / Treatment
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* Device: Silent™ Hip


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Silent™ Hip<br>A short cementless, femoral component for use in total hip arthroplasty | Device: Silent™ Hip<br>* A short cementless, femoral component for use in total hip arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier survivorship |  | 5 years post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score |  | 6 weeks-6 mths | 
| University of California Los Angeles (UCLA) Activity Score |  | 6 weeks-6 mths | 
| EuroQol EQ-5D |  | 6 weeks-6 mths | 
| Harris Hip Score |  | 6 weeks-6 mths | 
| Radiographic analysis |  | pre-discharge | 
| Oxford Hip Score |  | 2 years | 
| Oxford Hip Score |  | 3 years | 
| Oxford Hip Score |  | 4 Years | 
| Oxford Hip Score |  | 5 years | 
| Oxford Hip Score |  | 6 Years | 
| Oxford Hip Score |  | 7 Years | 
| Oxford Hip Score |  | 8 Years | 
| Oxford Hip Score |  | 9 years | 
| Oxford Hip Score |  | 10 Years | 
| Oxford Hip Score |  | 11 Years | 
| Oxford Hip Score |  | 12 Years | 
| Oxford Hip Score |  | 13 Years | 
| Oxford Hip Score |  | 14 Years | 
| Oxford Hip Score |  | 15 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 2 years | 
| University of California Los Angeles (UCLA) Activity Score |  | 3 years | 
| University of California Los Angeles (UCLA) Activity Score |  | 4 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 5 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 6 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 7 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 8 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 9 years | 
| University of California Los Angeles (UCLA) Activity Score |  | 10 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 11 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 12 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 13 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 14 Years | 
| University of California Los Angeles (UCLA) Activity Score |  | 15 years | 
| EuroQol EQ-5D |  | 2 Years | 
| EuroQol EQ-5D |  | 3 Years | 
| EuroQol EQ-5D |  | 4 Years | 
| EuroQol EQ-5D |  | 5 Years | 
| EuroQol EQ-5D |  | 6 years | 
| EuroQol EQ-5D |  | 7 years | 
| EuroQol EQ-5D |  | 8 Years | 
| EuroQol EQ-5D |  | 9 Years | 
| EuroQol EQ-5D |  | 10 Years | 
| EuroQol EQ-5D |  | 11 Years | 
| EuroQol EQ-5D |  | 12 Years | 
| EuroQol EQ-5D |  | 13 Years | 
| EuroQol EQ-5D |  | 14 Years | 
| EuroQol EQ-5D |  | 15 Years | 
| Harris Hip Score |  | 2 Years | 
| Harris Hip Score |  | 5 Years | 
| Harris Hip Score |  | 10 Years | 
| Harris Hip Score |  | 15 Years | 
| Radiographic analysis |  | 6 weeks - 6 mths | 
| Radiographic analysis |  | 1 year | 
| Radiographic analysis |  | 2 Years | 
| Radiographic analysis |  | 5 Years | 
| Radiographic analysis |  | 10 years | 
| Radiographic analysis |  | 15 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Replacement, Femoral Component