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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional TKA | Active Comparator | Conventional TKA, with no patient-specific instrumentation or robotic assistance |
|
| Robotic-assisted TKA | Experimental | ROSA Knee System assisted TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted total knee arthroplasty (raTKA) | Procedure | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Gait, walking | comfortable walking speed | Pre-operative, 12-months post-operative |
| Gait, sit-to-stand | ground reaction force difference between left and right foot during sit-to-stand-transfer |
Inclusion Criteria:
Exclusion Criteria:
- Rheuma-/trauma-indicated knee arthroplasty
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| Name | Affiliation | Role |
|---|---|---|
| Jasper Most, PhD | Zuyderland Medical Center | Principal Investigator |
| Bert Boonen, PhD | Zuyderland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuyderland Medical Center | Sittard | Limburg | 6162 BG | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39815282 | Derived | Eijking HM, Dorling IM, van Haaren EH, Hendrickx R, Nijenhuis T, Schotanus MGM, Bouwman L, Most J, Boonen B. Image-based robotic (ROSA(R) knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty : Study protocol and the inverse kinematic alignment in 8-steps using the ROSA(R) Knee system for knee balancing technique explained. J Orthop Surg Res. 2025 Jan 15;20(1):47. doi: 10.1186/s13018-024-05427-y. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D024821 | Metabolic Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| conventional total knee arthroplasty | Procedure | 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. |
|
| 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. |
| Pre-operative, 12-months post-operative |
| Gait, single-leg-stance | standard deviation in center of mass and pressure during single-leg-stance | Pre-operative, 12-months post-operative |
| Proprioception, reaction time | 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. | Pre-operative, 12-months post-operative |
| Proprioception, angle at movement | 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. | Pre-operative, 12-months post-operative |
| D012216 |
| Rheumatic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001519 | Behavior |