ROSA Knee System vs Conventional Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical study, in which 150 patients with end-stage osteoarthritis will be enrolled to ROSA®-assisted knee arthroplasty or conventional knee arthroplasty. Patients are recruited at Zuyderland Medical Center, enrolled pre-operatively and followed up for 12 months post-surgery. In- and exclusion criteria are stated below. After recruitment, participants will be invited for a pre-operative visit. During this pre-operative visit Informed Consent is signed and completion of patient-reported outcome measures (PROMs) is checked. Additionally, measurements regarding body composition, strength and fitness and metabolic outcomes are performed. Participants will have a blood sample taken. Scans, adverse event and medication use will be confirmed. Participants will receive a ActiGraph for collecting data from physical activity. Of all patients, 72 will undergo additional measurements (gait, proprioception). During surgery ROSA- and surgery-data will be collected. Post-operative participants will have a 6-weeks, 3-month and 12-month visit. During these visits pre-operative measurements are repeated.

Official Title
-----------------
The Effect of ROSA®-Assisted Knee Arthroplasty on Clinical Outcomes

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Robotic-assisted total knee arthroplasty (raTKA)
* Procedure: conventional total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for primary TKA age 40-90 years Body-Mass-Index 18.5-50.0 kg/m2 American Society of Anaesthesiologists Class I-III Willingness and capability to understand and follow protocol Exclusion Criteria: - Rheuma-/trauma-indicated knee arthroplasty

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional TKA<br>Conventional TKA, with no patient-specific instrumentation or robotic assistance | Procedure: conventional total knee arthroplasty<br>* total knee arthroplasty is an orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic. In conventional TKAs, no patient-specific instrumentation or robotic assistance is provided.<br>|
| Experimental: Robotic-assisted TKA<br>ROSA Knee System assisted TKA | Procedure: Robotic-assisted total knee arthroplasty (raTKA)<br>* Robotic-assisted total knee arthroplasty is an orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic. The robot (ROSA Knee System, Zimmer Biomet, US) assists in planning and placement of the implants and resection sites.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score | The Oxford Knee Score (OKS, best to worst 0-48) measures pain intensity and functional limitation of the knee during various activities. The questionnaire consists of 12 items. The maximum total score is 60 and corresponds with the highest pain intensity and functional limitation. | 3-months post-operative | 
| Oxford Knee Score | The Oxford Knee Score (OKS, best to worst 0-48) measures pain intensity and functional limitation of the knee during various activities. The questionnaire consists of 12 items. The maximum total score is 60 and corresponds with the highest pain intensity and functional limitation. | 12-months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life-Index | European Quality of Life-questionnaire-5-dimension-3-level (worst to best, -0.329 to 1.000) | Pre-operative, 3-months and 12-months post-operative. | 
| Symptoms | Western Ontario and McMaster Universities Osteoarthritis Index (worst to best 0-100) | Pre-operative, 3-months and 12-months post-operative. | 
| Pain Catastrophizing | Pain Catastrophizing Scale (best to worst, 0-52) | Pre-operative, 3-months and 12-months post-operative. | 
| Pain Sensitivity | Pain Sensitivity Questionnaire (best to worst, 0-140) | Pre-operative, 3-months and 12-months post-operative. | 
| Mobility | De Morten Mobility index (worst to best, 0-100) | Pre-operative, 3-months and 12-months post-operative. | 
| Complications | Registered complications during hospitalization | During in-patient stay for indicated surgery (up to 5 days) | 
| Duration of surgery | Registered duration of surgery | During surgery | 
| Blood loss | Registered blood loss during hospitalization | During surgery | 
| Length of hospital stay | Duration from patient intake until discharge | During in-patient stay for indicated surgery (up to 5 days) | 
| Anesthesia | Type of anesthesia used | During surgery | 
| Stability of the knee | Ligament tension, assessed by the ROSA Knee System | Immediately after the surgery | 
| Knee implant position | Resection, assessed by the ROSA Knee System | Immediately after the surgery | 
| Mobility of the knee | Flexion, Extension of knee, assessed by the ROSA Knee System | During and immediately after the surgery | 
| Mechanical axis of the leg. | Hip-Knee-Alignment, by CT | 3-months post-surgery | 
| Implant Survival | Duration until failure (required revision) | 90-day and 1-year | 
| Patient Survival | Duration until death | 90-day and 1-year | 
| Physical Activity | Steps per day, assessed for 7 continuous days using hip-worn accelerometer | Pre-operative, 3-months and 12-months post-operative. | 
| Metabolic Syndrome | Metabolic Syndrome Severity Scale (no predefined range, higher scores indicate worse outcome) | Pre-operative, 3-months and 12-months post-operative. | 
| Body composition | Fat mass, measured as % using bioimpedance analysis | Pre-operative, 3-months and 12-months post-operative. | 
| Handgrip strength | handgrip strength using hand-held dynamometer | Pre-operative, 3-months and 12-months post-operative. | 
| Physical condition | Completed distance in 2-minute walking | Pre-operative, 3-months and 12-months post-operative. | 
| Physical strength | Completed sit-to-stand-transfers within 30 seconds | Pre-operative, 3-months and 12-months post-operative. | 
| Physical mobility | Time to stand up, walk 3m back and forth and sit down again (timed-up-and-go test) | Pre-operative, 3-months and 12-months post-operative. | 
| Cost of procedure, implants | Number implant sizes readily available, and used | During Surgery | 
| Cost of procedure, personnel | Number of Personnel during surgery | During Surgery | 
| Productivity | Institute for Medical Technology Assessment Productivity Cost Questionnaire (worst to best, 0-100) | Pre-operative, 3-months and 12-months post-operative. | 
| Medical consumption | Institute for Medical Technology Assessment Medical Consumption Questionnaire (outcome in Euro) | Pre-operative, 3-months and 12-months post-operative. | 
| Work Ability Index | Work Ability Index Questionnaire (worst to best, 0-100) | Pre-operative, 3-months and 12-months post-operative. | 
| Work Productivity and Activity Impairment | Work Productivity and Activity Impairment-Questionnaire (worst to best, 0-100) | Pre-operative, 3-months and 12-months post-operative. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Robotic-assisted arthroplasty, Knee arthroplasty, Gait, Metabolic Syndrome, ROSA Knee System, Physical Activity, Cost-effectiveness