ROSA Knee System vs Conventional Total Knee Arthroplasty
Key facts
- Who runs it
- Zuyderland Medisch Centrum
- Where
- Netherlands1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 150 people enrolled
- Started
- 16 Dec 2022
- Expected to end
- Dec 2035
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Robotic-assisted total knee arthroplasty (raTKA)
- conventional total knee arthroplasty
- Record updated
- 24 July 2024
Who can take part
- Age
- 40 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Rheuma-/trauma-indicated knee arthroplasty
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Conventional TKAExisting treatment, for comparison
Conventional TKA, with no patient-specific instrumentation or robotic assistance
Treatment: conventional total knee arthroplasty
- Robotic-assisted TKATreatment being tested
ROSA Knee System assisted TKA
Treatment: Robotic-assisted total knee arthroplasty (raTKA)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of ROSA®-Assisted Knee Arthroplasty on Clinical Outcomes
- Record updated
- 24 July 2024