ROSA Knee System vs Conventional Total Knee Arthroplasty
NCT ID: NCT05685693
Last Updated: 2024-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2022-12-16
2035-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional TKA
Conventional TKA, with no patient-specific instrumentation or robotic assistance
conventional 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.
Robotic-assisted TKA
ROSA Knee System assisted TKA
Robotic-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.
Interventions
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Robotic-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.
conventional 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.
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
90 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Zuyderland Medisch Centrum
OTHER
Responsible Party
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Principal Investigators
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Jasper Most, PhD
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medical Center
Bert Boonen, PhD
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medical Center
Locations
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Zuyderland Medical Center
Sittard, Limburg, Netherlands
Countries
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References
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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.
Other Identifiers
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Z2021179
Identifier Type: -
Identifier Source: org_study_id
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