Multi-centre Study to Assess the Long-term Performance of the Deltamotion Cup System in Primary 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 of the DeltaMotion cup system 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 DeltaMotion Cup System in Subjects Requiring a Total Hip Replacement

Conditions
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Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Avascular Necrosis, Traumatic Femoral Fractures, Congenital Hip Dysplasia

Intervention / Treatment
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* Device: Delta Motion


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 Clinical Investigation and from whom consent has been obtained. iii) Subjects who, in the opinion of the 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-operative follow-ups. iv) Subjects suitable for a cementless total hip replacement using the DeltaMotion Cup System, in accordance with all applicable Instructions For Use 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 Clinical Investigation. ii) Women who are pregnant. iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. iv) Subjects who have participated in a Clinical Investigation with an investigational product in the last 12 months. v) Subjects who are currently involved in any injury litigation claims.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Delta Motion<br>A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement | Device: Delta Motion<br>* A cementless acetabular cup with a pre-assembled ceramic liner 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 | To determine survivorship of the DeltaMotion Cup System at 3 years | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier survivorship | To determine survivorship of the DeltaMotion Cup System at 10 years | 10yrs post-surgery | 
| Harris Hip Score | Change from baseline in the Harris Hip Score. The Harris Hip Score is used to measure the outcome of total hip replacement and covers the areas of pain, function, absence of deformity and range of motion. | 10yrs post-surgery | 
| Oxford Hip Score | Change from baseline in the Oxford Hip Score. The Oxford hip score is a patient completed outcomes score which is designed to assess function and pain with patients undergoing hip replacement surgery. | 10yrs post-surgery | 
| University of California Los Angeles (UCLA) Score | Change from baseline in the UCLA Quality of Life Score. UCLA is a patient completed outcome score used in hip replacement | 10yrs post-surgery | 
| Western Ontario and McMaster Universities (WOMAC) Score | Change from baseline in the WOMAC. WOMAC is a patient complete outcome score to assess pain, disability and joint stiffness in Osteoarthritis of the hip and knee | 10yrs post-surgery | 
| Radiological analysis | Acetabular Migration (vertical or horizontal) less than 5mm Acetabular Migration (varus or valgus) less than 5 degrees No loosening - absence of acetabular radiolucencies of greater than 2mm in two zones. | 10yrs post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Replacement, Cementless, Ceramic on Ceramic, Hip