Knee Osteoarthritis
Conditions
Keywords
Robotic-assisted arthroplasty, Knee arthroplasty, Gait, Metabolic Syndrome, ROSA Knee System, Physical Activity, Cost-effectiveness
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.
Interventions
PROCEDURERobotic-assisted total knee arthroplasty (raTKA)
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.
PROCEDUREconventional total knee arthroplasty
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.
Sponsors
Zimmer Biomet
Zuyderland Medisch Centrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Score | 3-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
| Measure | Time frame | Description |
|---|---|---|
| Mobility of the knee | During and immediately after the surgery | Flexion, Extension of knee, assessed by the ROSA Knee System |
| 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) |
| Work Ability Index | Pre-operative, 3-months and 12-months post-operative. | Work Ability Index Questionnaire (worst to best, 0-100) |
| 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) |
| 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) |
| Symptoms | Pre-operative, 3-months and 12-months post-operative. | Western Ontario and McMaster Universities Osteoarthritis Index (worst to best 0-100) |
| 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) |
| Complications | During in-patient stay for indicated surgery (up to 5 days) | Registered complications during hospitalization |
| Duration of surgery | During surgery | Registered duration of surgery |
| 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 |
| Anesthesia | During surgery | Type of anesthesia used |
| Stability of the knee | Immediately after the surgery | Ligament tension, assessed by the ROSA Knee System |
| Knee implant position | Immediately after the surgery | Resection, assessed by the ROSA Knee System |
| Mechanical axis of the leg. | 3-months post-surgery | Hip-Knee-Alignment, by CT |
| Implant Survival | 90-day and 1-year | Duration until failure (required revision) |
| 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 |
| Metabolic Syndrome | Pre-operative, 3-months and 12-months post-operative. | Metabolic Syndrome Severity Scale (no predefined range, higher scores indicate worse outcome) |
| 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 |
| Physical condition | Pre-operative, 3-months and 12-months post-operative. | Completed distance in 2-minute walking |
| Physical strength | Pre-operative, 3-months and 12-months post-operative. | Completed sit-to-stand-transfers within 30 seconds |
| 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) |
| Cost of procedure, implants | During Surgery | Number implant sizes readily available, and used |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gait, single-leg-stance | Pre-operative, 12-months post-operative | standard deviation in center of mass and pressure during single-leg-stance |
| Proprioception, reaction time | Pre-operative, 12-months post-operative | Proprioception of the knee will be measured in a motorized carriage. Patients will lay on a hospital bed where their leg is fixed in the motorized carriage. This sled will passively extend and flex the knee. When patients get the sensation of movement, they have to push a button. The reaction time and the angle to sense the movement will be measured digitally. |
| Proprioception, angle at movement | Pre-operative, 12-months post-operative | Proprioception of the knee will be measured in a motorized carriage. Patients will lay on a hospital bed where their leg is fixed in the motorized carriage. This sled will passively extend and flex the knee. When patients get the sensation of movement, they have to push a button. The reaction time and the angle to sense the movement will be measured digitally. |
| Gait, walking | Pre-operative, 12-months post-operative | comfortable walking speed |
| Gait, sit-to-stand | Pre-operative, 12-months post-operative | ground reaction force difference between left and right foot during sit-to-stand-transfer |
Countries
Netherlands
Outcome results
None listed