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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: DePuy Silent™ Hip femoral prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, aged 18 years or above at the point of screening for participation. Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-treatment follow-ups. Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement and are considered suitable for a cementless femoral and acetabular component. Exclusion Criteria: Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. Women who are pregnant. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. Subjects who have participated in a clinical study with an investigational product in the last 6 months. This exclusion does not apply to those subjects who are participating in the pilot investigation of the DePuy Silent Hip (CT01/27) Subjects who are currently involved in any injury litigation claims. Subjects who have osteonecrosis of the femoral neck Subjects with significant bone loss or gross deformity in the region of the neck of the femur as identified on the pre-operative radiographs, where in the Investigator's opinion, there could be considerable migration of the DePuy Silent Hip or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the DePuy Silent Hip. Subjects with a Charnley C classification. Subjects with an active local or systemic infection. Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified. Subjects with Paget's disease

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: DePuy Silent™ Hip femoral prosthesis<br>A short cementless, femoral component for use in total hip arthroplasty | Device: DePuy Silent™ Hip femoral prosthesis<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 |
| --- | --- | --- |
| Incidence of complications |  | 6mths post-surgery | 
| Harris Hip score change at 6mths post-surgery |  | 6mths post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery | 
| Oxford Hip Score |  | 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery | 
| UCLA Activity Rating |  | 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery | 
| Incidence of post operative radiological signs |  | 7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery | 
| Change in bone mineral density |  | 7days, 3mths, 6mths, 1yr and 2yrs post-surgery | 
| Kaplan-Meier Survivorship Calculations |  | 3 months, 6 months, and Annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Cementless, Conservative