Functional Evaluation of a Standard and a High-flexion Knee Prosthesis Using Thigh-calf Contact Force Measurements

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether subjects receiving a high-flexion knee prosthesis show a better knee function than patients receiving a standard knee prosthesis. Thigh-calf contact force measurements are used to quantify knee function. The investigators' hypothesis is that high-flexion knees show a better knee function.

Detailed Description
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Study title: Functional evaluation of a standard and a high-flexion knee prosthesis using thigh-calf contact force measurements. Objective: The objective of this study is to investigate whether subjects receiving a high flexion knee prosthesis (Sigma RP-F, J&J, UK) show a better knee function than patients receiving a standard knee prosthesis (Sigma FB, J&J, UK). Study Design: Prospective double blind randomized study. Study population: Subjects who will receive total knee arthroplasty (TKA) because of invalidating gonarthritis based on primary osteoarthritis or rheumatic disorders or trauma. Intervention: 28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.

Official Title
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In-vivo Study Investigating the Difference in Functional Outcome Between Two Types of Knee Prostheses: the Sigma FB (Depuy, J&J, UK; Standard Implant) and the Sigma RP-F (Depuy, J&J, UK; High-flexion Implant)

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Procedure: Total Knee Arthroplasty (TKA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving a total knee replacement due to disabling gonarthrosis (cartilage damage): Primary due to osteo-arthritis Secondary due to rheumatoid arthritis or trauma Exclusion Criteria: Patients suffering from juvenile rheuma Patients suffering from hemophilia Patients that are incapable to give informed consent Patients who receive a total knee replacement due to an oncological resection Patients who have received a total knee replacement on the contralateral leg Patients who have disabling gonarthrosis on both legs Patients having a BMI < 25 kg/m^2 Patients who have to receive a different prosthesis than used in this study for biomechanical reasons (e.g. revision prosthesis)
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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard knee prosthesis<br>'standard' knee prosthesis (Sigma FB, J&J, UK). | Procedure: Total Knee Arthroplasty (TKA)<br>* 28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.<br>* Other names: Sigma FB, J&J, UK;|
| Active Comparator: High flexion knee prosthesis<br>'high flexion' knee prosthesis (Sigma RP-F, J&J, UK). | Procedure: Total Knee Arthroplasty (TKA)<br>* 28 subjects will receive the standard Sigma FB knee prosthesis. 28 subjects will receive the high flexion Sigma RP-F knee prosthesis.<br>* Other names: Sigma FB, J&J, UK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thigh-calf contact force |  | pre-op and 1-year post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passive/active maximal knee flexion angle |  | pre-op and 1-year post-op | 
| BMI, weight and length |  | pre-op and 1-year post-op | 
| Thigh and calf circumference |  | pre-op and 1-year post-op | 
| IKS, WOMAC and VAS (pain/satisfaction) score |  | pre-op and 1-year post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prosthesis