ROSA Knee System vs Conventional Total Knee Arthroplasty

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.

NCT Number	NCT05685693
Lead Sponsor	Zuyderland Medisch Centrum Collaborators: Zimmer Biomet
Conditions	Knee Osteoarthritis
Enrollment	150 participants
Start Date	2022-12-16
Primary Completion	2025-12 (estimated)
Study Completion	2035-12 (estimated)
Updated on ClinicalTrials.gov	2024-07-24