RSA Study of Persona TKA With CR vs MC Polyethylene

Study Overview
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Brief Summary
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The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result. We plan also to do a 5 year follow-up of the patients with RSA and PROMS.

Official Title
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Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Medial Congruent Polyethylene (MC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis of the knee necessitating knee replacement ASA I-III BMI 18 - 35 Exclusion Criteria: Joint sepsis in history immunosuppresive drugs last 5 years Rheumatoid arthritis Severe osteoporosis or other metabolic bone diseases Neuromuscular diseases Personal disorders suspected of limiting rehab and completion of the trial period Previous osteotomy of affected limb Intra-articular knee fracture of affected limb Peroperative fracture Severe deformity of affected joint in need of augmentation or excessive release Obvious need for more constrained knee than CR

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Cruciate Retaining Polyethylene (CR)<br>This is the standard Polyethylene articular surface | |
| Active Comparator: Medial Congruent Polyethylene (MC)<br>The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy. | Device: Medial Congruent Polyethylene (MC)<br>* One group receives the conventional CR surface and the other the new MC articular surface<br>* Other names: MC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiostereometry (RSA) | Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis) | First postoperative day, 3 months, 1 year, 2 years and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computer Tomography (CT) | Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position | Preoperatively and 3 months postoperatively | 
| Conventional radiography | Measure the preoperative malalignment of the knee and the postoperatively achieved alignment and achieved prosthesis position | Preoperatively and 3 months postoperatively | 
| General health questionnaire | EuroQol (EQ-5D) -standardized instrument for use of general health outcome | Preoperatively, 1, 2 and 5 years postoperatively | 
| Knee specific health questionnaire | Knee disability and Osteoarthritis Outcome Score (KOOS) - this is a knee specific questionnaire measuring patients knee function and pain situation | Preoperatively, 1, 2 and 5 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiostereometry (RSA), Total Knee Arthroplasty