Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

Study Overview
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Brief Summary
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Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.

Official Title
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Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients

Conditions
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Arthroplasty Complications

Intervention / Treatment
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* Device: Ceramic-on-ceramic uncemented hip arthroplasty
* Device: Metal-on-polyethylene uncemented total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary osteoarthritis secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis) Exclusion Criteria: inflammatory arthritis hip joint infection

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 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
Interventional Model Description: Prospective randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metal-on-conventional polyethylene<br>Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a CoCr prosthetic femoral head and an acetabular liner made of intermedially cross-linked polyethylene polyethylene (Duration, Stryker, Mahwah, NJ, US). | Device: Metal-on-polyethylene uncemented total hip arthroplasty<br> <br> |
| Experimental: Ceramic-on-ceramic<br>Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a prosthetic femoral head and an acetabular liner made of alumina ceramic (Biolox Forte, Ceramtec, Plochingen, Germany). | Device: Ceramic-on-ceramic uncemented hip arthroplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteolysis frequency change between 7 and 15 years | Osteolysis frequency (%) measured with computed tomography, | Change between 7 to 15 years after surgery | 
| Osteolysis size change between 7 and 15 years | Osteolysis size (cm3) measured with computed tomography | Change between 7 and 15 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Articulation wear at 7 years | Articulation wear as measured with radiostereometry, mm/year | At 7 years after surgery | 
| Articulation wear at 15 years | Articulation wear as measured with radiostereometry, mm/year | 15 years after surgery | 
| Implant fixation at 7 years | Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry | 7 years after surgery | 
| Implant fixation at 15 years | Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry | At 15 years after surgery | 
| Clinical function at 7 years | Harris Hip Score (0-100) | 7 years after surgery | 
| Clinical function at 15 years | Harris Hip Score (0-100) | 15 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomaterials, Implant wear, hip arthroplasty, osteolysis, aseptic loosening