ROSA Knee System vs Conventional Total Knee Arthroplasty (ROSA_RCT)

Zuyderland Medisch Centrum

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Procedure: Robotic-assisted total knee arthroplasty (raTKA); Procedure: conventional total knee arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05685693

Z2021179

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Rheuma-/trauma-indicated knee arthroplasty

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Conventional TKA

Active Comparator group

Description:

Conventional TKA, with no patient-specific instrumentation or robotic assistance

Treatment:

Procedure: conventional total knee arthroplasty

Robotic-assisted TKA

Experimental group

Description:

ROSA Knee System assisted TKA

Treatment:

Procedure: Robotic-assisted total knee arthroplasty (raTKA)