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Recruiting
NCT05685693
ROSA Knee System vs Conventional Total Knee Arthroplasty
Conditions: Knee Osteoarthritis
Sex: All
Ages: 40 Years – 90 Years
Phase: NA
Enrollment: 150
Sponsor: Zuyderland Medisch Centrum
Location: Netherlands
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.
Eligibility Criteria
Inclusion Criteria:Eligible for primary TKAage 40-90 yearsBody-Mass-Index 18.5-50.0
kg/m2American Society of Anaesthesiologists Class I-IIIWillingness and capability to understand and follow protocolExclusion Criteria:- Rheuma-/trauma-indicated knee arthroplasty
Source: ClinicalTrials.gov (NCT05685693). StuddyBuddy aggregates publicly available trial information.