ROSA Knee System vs Conventional Total Knee Arthroplasty
- Conditions
- Knee Osteoarthritis
- Interventions
- Procedure: conventional total knee arthroplastyProcedure: Robotic-assisted total knee arthroplasty (raTKA)
- Registration Number
- NCT05685693
- Lead Sponsor
- Zuyderland Medisch Centrum
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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
- Rheuma-/trauma-indicated knee arthroplasty
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional TKA conventional total knee arthroplasty Conventional TKA, with no patient-specific instrumentation or robotic assistance Robotic-assisted TKA Robotic-assisted total knee arthroplasty (raTKA) ROSA Knee System assisted TKA
- Primary Outcome Measures
Name Time Method Oxford Knee Score 12-months post-operative 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.
- Secondary Outcome Measures
Name Time Method Stability of the knee Immediately after the surgery Ligament tension, assessed by the ROSA Knee System
Pain Catastrophizing Pre-operative, 3-months and 12-months post-operative. Pain Catastrophizing Scale (best to worst, 0-52)
Pain Sensitivity Pre-operative, 3-months and 12-months post-operative. Pain Sensitivity Questionnaire (best to worst, 0-140)
Mobility Pre-operative, 3-months and 12-months post-operative. De Morten Mobility index (worst to best, 0-100)
Duration of surgery During surgery Registered duration of surgery
Anesthesia During surgery Type of anesthesia used
Mobility of the knee During and immediately after the surgery Flexion, Extension of knee, assessed by the ROSA Knee System
Symptoms Pre-operative, 3-months and 12-months post-operative. Western Ontario and McMaster Universities Osteoarthritis Index (worst to best 0-100)
Patient Survival 90-day and 1-year Duration until death
Physical Activity Pre-operative, 3-months and 12-months post-operative. Steps per day, assessed for 7 continuous days using hip-worn accelerometer
Body composition Pre-operative, 3-months and 12-months post-operative. Fat mass, measured as % using bioimpedance analysis
Handgrip strength Pre-operative, 3-months and 12-months post-operative. handgrip strength using hand-held dynamometer
Cost of procedure, implants During Surgery Number implant sizes readily available, and used
Physical strength Pre-operative, 3-months and 12-months post-operative. Completed sit-to-stand-transfers within 30 seconds
Quality of Life-Index Pre-operative, 3-months and 12-months post-operative. European Quality of Life-questionnaire-5-dimension-3-level (worst to best, -0.329 to 1.000)
Blood loss During surgery Registered blood loss during hospitalization
Length of hospital stay During in-patient stay for indicated surgery (up to 5 days) Duration from patient intake until discharge
Knee implant position Immediately after the surgery Resection, assessed by the ROSA Knee System
Implant Survival 90-day and 1-year Duration until failure (required revision)
Work Productivity and Activity Impairment Pre-operative, 3-months and 12-months post-operative. Work Productivity and Activity Impairment-Questionnaire (worst to best, 0-100)
Complications During in-patient stay for indicated surgery (up to 5 days) Registered complications during hospitalization
Mechanical axis of the leg. 3-months post-surgery Hip-Knee-Alignment, by CT
Metabolic Syndrome Pre-operative, 3-months and 12-months post-operative. Metabolic Syndrome Severity Scale (no predefined range, higher scores indicate worse outcome)
Physical condition Pre-operative, 3-months and 12-months post-operative. Completed distance in 2-minute walking
Cost of procedure, personnel During Surgery Number of Personnel during surgery
Productivity Pre-operative, 3-months and 12-months post-operative. Institute for Medical Technology Assessment Productivity Cost Questionnaire (worst to best, 0-100)
Medical consumption Pre-operative, 3-months and 12-months post-operative. Institute for Medical Technology Assessment Medical Consumption Questionnaire (outcome in Euro)
Physical mobility Pre-operative, 3-months and 12-months post-operative. Time to stand up, walk 3m back and forth and sit down again (timed-up-and-go test)
Work Ability Index Pre-operative, 3-months and 12-months post-operative. Work Ability Index Questionnaire (worst to best, 0-100)
Trial Locations
- Locations (1)
Zuyderland Medical Center
🇳🇱Sittard, Limburg, Netherlands