The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.

Detailed Description
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Total knee arthroplasty (TKA) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. In 2015, 6093 patients received primary TKA in Norway. Despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. Efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (PCL). Prostheses for TKA have evolved into designs that either preserve or sacrifice the PCL. In patients with a functional PCL, the decision of which design is selected depends largely on the favor and training of the surgeon. To further improve TKA patient outcomes, a better understanding of the role of these differing PCL treatments is needed. Thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 TKA implant designs (2 PCL-sacrificing and 1 PCL-retaining). We will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. This study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants.

Official Title
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The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial

Conditions
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Gonarthrosis; Primary, Degenerative Joint Disease of Knee

Intervention / Treatment
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* Procedure: Knee arthroplasty, Cruciate retaining
* Procedure: Knee arthroplasty, Anterior stabilized
* Procedure: Knee arthroplasty, Posterior stabilized


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary osteoarthritis Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs Intact PCL (assessed preoperatively and verified during surgery) Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA) Body mass index ≤ 35 kg/m2 ASA (American Society of Anaesthesiologists) score I or II Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis Exclusion Criteria: Prior ACL (anterior cruciate ligament) surgery Impaired collateral ligaments Secondary osteoarthritis of the knee Previous osteotomy Rheumatic disease Flexion less than 90 degrees Flexion contracture over 10 degrees Peripheral neuropathy Malignancy Patients who do not speak Norwegian

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Knee arthroplasty, Cruciate retaining<br>Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert. | Procedure: Knee arthroplasty, Cruciate retaining<br>* Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design<br>|
| Active Comparator: Knee arthroplasty, Anterior stabilized<br>Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert. | Procedure: Knee arthroplasty, Anterior stabilized<br>* Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design<br>|
| Active Comparator: Knee arthroplasty, Posterior stabilized<br>Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design. | Procedure: Knee arthroplasty, Posterior stabilized<br>* Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and osteoarthritis outcome score (KOOS) | KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire. | Pre-operative, 1, 2 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford knee score (OKS) | OKS is a brief patient-completed questionnaire for patients undergoing total knee arthroplasty. It reflects the patient's assessment of their knee-related health status and benefits of treatment. | Pre-operative, 1, 2 and 5 years | 
| EQ-5D-5L | EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life | Pre-operative, 1, 2 and 5 years | 
| Range of motion (ROM) | ROM will be measured by extension and flexion with a goniometer preoperatively at baseline and at each follow-up visit (6 weeks, 3 months, 12 months, 24 months and 60 months | Pre-operative, 6 weeks, 3, 12, 24 and 60 months | 
| Kinematic radiostereometric analysis (RSA) | Knee motion while walking up and down stairs, and during squatting and kneeling activities will be recorded using video fluoroscopy (dynamic RSA) at 12 months. | After 12 months | 
| Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs | Radiographs obtained for assessment of fixation of the prosthesis and the alignment. | Pre-operative, 3, 12, 24 and 60 months | 
| Brief Pain Inventory | We will use three single items to measure worst pain intensity, average pain intensity, and pain interference with walking. Patients rate their pain intensity and pain interference with walking on an 11-point numeric rating scale from 0-10, where 0=no pain/no interference and 10=worst imaginable pain/complete interference. | Pre-operative, 6 weeks, 3, 12, 24 and 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior stabilized, Cruciate retaining, Anterior stabilized, Posterior cruciate ligament, Degenerative knee joint disease, Knee injury and Osteoarthritis Outcome Score, Kinematic radiostereometry