A Randomised Single Centre Study to Compare the Long-term Wear Characteristics of Marathon™ and Enduron™ Polyethylene Cup Liners in Primary Total Hip Replacement

Study Overview
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Brief Summary
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The purpose of this study is to compare the performance and compare the wear characteristics of two polyethylene cup liners, Marathon™ and Enduron™, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the polyethylene cup liners, Marathon™ or Enduron™ and will be evaluated at regular intervals using clinical and x-ray assessments.

Detailed Description
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The original protocol intended to perform clinical assessment using the Harris Hip Score, Merle D'Aubigne score and UCLA Activity Level Rating at 6 months, 1 year, 2 years, 3 years, 4 years, 5 years and 10 years post-operative. Merle D'Aubigne score evaluation was removed per Amendment 2. However, protocol-specified data collected included only the linear and volumetric wear and incidence and pattern of radiological signs at 10 years post surgery. Data collected outside of the protocol included Oxford Hip Score and SF-12 for mental and physical well-being at 10 years post surgery and revision for any reason.

Official Title
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A Prospective, Randomised, Controlled, Single Centre, Blinded Study of the Wear Characteristics of Two Polyethylene Bearing Surfaces, Enduron vs. Marathon

Conditions
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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: Marathon™
* Device: Enduron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i) Male or female subjects, aged between 45 and 75 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 with non-inflammatory arthritis of the hip who require a primary hip arthroplasty and are considered by the Clinical Investigator to be suitable for a cemented femoral component and an uncemented acetabular component. v) Subjects who have a Charnley C classification vi) Subjects who have undergone a contralateral hip replacement within past 6 months vii) Subjects with a poorly functioning contralateral hip replacement or one which has been identified as requiring revision viii) The first hip replacement scheduled for subjects identified as requiring primary bi-lateral hip replacements which will not be conducted simultaneously (i.e. on the same day). 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) Women who are pregnant. iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. iv) Subjects who have participated in a clinical study with an investigational product in the last month.

Ages Eligible for Study
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Minimum Age: 45 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marathon™<br>Moderately cross-linked polyethylene liner in a modular acetabular component | Device: Marathon™<br>* Moderately cross-linked polyethylene liner in a modular acetabular component<br>|
| Active Comparator: Enduron™<br>Standard UHMWPE polyethylene liner in a modular acetabular component | Device: Enduron<br>* Standard polyethylene liner in a modular acetabular component<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the linear and volumetric wear at the three-year time point. |  | 10yrs post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the difference in the 3D femoral head displacement between Enduron™ and Marathon™ three-years post-operatively |  | 10yrs post surgery | 
| Radiographic analysis |  | 10yrs post surgery | 
| Oxford Hip Score |  | 10yrs post surgery | 
| SF-12 for Mental and Physical well-being |  | 10yrs post surgery | 

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