Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement

Study Overview
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Brief Summary
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The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.

Official Title
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Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial

Conditions
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Osteoarthritis, Hip, Osteoarthritis

Intervention / Treatment
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* Device: E-Poly liner
* Device: ArComXL liner
* Device: 32 mm femoral head
* Device: 36 mm femoral head


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary idiopathic arthritis, Eligible for uncemented total hip arthroplasty 40 to70 years of age, Cup size of 54mm and above Exclusion Criteria: Anteversion where non-standard stem can be used, Dysplasia (Center-edge angle of Wiberg < 20°), Malignant condition Prior radiotherapy Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure), Complications during surgery (requiring screws in shell or femoral cerclage)

Ages Eligible for Study
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Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-Poly/32 mm<br>E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head. | Device: E-Poly liner<br>* E-Poly liner with a titanium cup<br>Device: 32 mm femoral head<br>* Stem with a 32 mm CoCr femoral head<br>|
| Active Comparator: E-Poly/36 mm<br>E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head. | Device: E-Poly liner<br>* E-Poly liner with a titanium cup<br>Device: 36 mm femoral head<br>* Stem with a 36 mm CoCr femoral head<br>|
| Active Comparator: ArComXL/32 mm<br>ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head. | Device: ArComXL liner<br>* ArComXL liner with a titanium cup<br>Device: 32 mm femoral head<br>* Stem with a 32 mm CoCr femoral head<br>|
| Active Comparator: ArComXL/36 mm<br>ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head. | Device: ArComXL liner<br>* ArComXL liner with a titanium cup<br>Device: 36 mm femoral head<br>* Stem with a 36 mm CoCr femoral head<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean head penetration from baseline to 5 year follow-up | Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up | From baseline to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean cup migration form baseline to 5 year follow-up | Mean cup migration assessed using RSA from baseline to 5 year follow-up | From baseline to 5 years | 
| Mean change in clinical outcome score from baseline to 5 year follow-up | Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score). | From baseline to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Joint Diseases, Musculoskeletal Diseases, radiostereometric analysis, Total hip arthroplasty