Clinical Outcome After Total Knee Arthroplasty Using CR or PS Inlay

Study Overview
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Brief Summary
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Compare knee flexion after cruciate-retaining and cruciate substituting Total Knee Arthroplasty.

Detailed Description
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The aim of this study is to compare knee Flexion after cruciate-retaining (CR) and cruciate-substituting (posterior stabilized - PS) Total Knee Arthroplasty (TKA). For this purpose, flexion and extension of the knee joint are measured using a goniometer preoperatively and up to ten years after surgery In addition, the clinical outcome will be assessed and evaluated using internationally recognised and evaluated scores (Knee Society Score, Oxford Knee Score, EQ5D, UCLA Activity Score). Patients are randomized to receive a PS or CR TKA. Patients are assessed before surgery, after 3 months, 1 year, 2 years, 5 years, 7 years and 10 years postoperatively.

Official Title
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Prospective Randomized Comparison of Cruciate-retaining and Cruciate Substituting Surgical Technique for Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: PS TKA
* Device: CR TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for TKA with a non-linked, bicondylar total knee replacement written informed consent Exclusion Criteria: Chronic pain patients Neuromuscular Diseases general illnesses that make mobilisation more difficult and/or prevent follow-up Known posterior cruciate ligament insufficiency Need for a higher degree of linkage BMI over 40 kg/m² Study doctor, his family, employees or other dependent persons

Ages Eligible for Study
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Minimum Age: 18 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: Randomization to one of two surgical techniques.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PS<br>Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty. | Device: PS TKA<br>* Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.<br>|
| Active Comparator: CR<br>Implantation of a cruciate retaining Total Knee Arthroplasty. | Device: CR TKA<br>* Implantation of a cruciate retaining Total Knee Arthroplasty.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Flexion | Knee flexion measured using a goniometer | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function assessed by the Knee Society Score | Knee Society Score | 10 years after surgery | 
| Patient Reported Outcome | Oxford Knee Score | 10 years after surgery | 
| Health-related Quality of Life | EQ-5D-3L | 10 years after surgery | 
| Activity assessed by UCLA activity score | UCLA activity score | 10 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Total Knee Replacement, Outcome, Implant Design