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

Study Overview
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Brief Summary
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The purpose of this study is to monitor the performance of the Summit™ 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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Prospective, Uncontrolled, Multi-Centre, Post-Marketing Surveillance Study to Evaluate the Long-Term Performance of Summit Tapered Hip in Cementless Total Hip Arthroplasty

Conditions
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Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis

Intervention / Treatment
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* Device: Summit Tapered Hip System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) Male or female subjects, aged between 18 and 70 years (inclusive). ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) Subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem. Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty. iii) Women who are pregnant. iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. v) Subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) Subjects who are currently involved in any injury litigation claims.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Summit Tapered Hip System<br>A cementless, tapered femoral component for use in total hip replacement | Device: Summit Tapered Hip System<br>* A cementless, tapered femoral component for use in total hip replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier survivorship calculated at the five-year time point |  | 5yrs post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier survivorship calculations |  | Annually | 
| Harris Hip score |  | 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery | 
| Oxford score |  | 6mths and Annually post-surgery | 
| UCLA activity rating |  | 6mths and Annually post-surgery | 
| Thigh pain analysis |  | 6mths and Annually post-surgery | 
| Radiological analysis |  | pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery | 

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