ROSA Knee System vs Conventional Total Knee Arthroplasty (ROSA_RCT)

The Effect of ROSA®-Assisted Knee Arthroplasty on Clinical Outcomes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: conventional total knee arthroplasty; Procedure: Robotic-assisted total knee arthroplasty (raTKA)

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Sittard, Limburg, Netherlands, 6162 BG
      • Zuyderland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional TKA; Conventional TKA, with no patient-specific instrumentation or robotic assistance	Procedure: 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.
Experimental: Robotic-assisted TKA; ROSA Knee System assisted TKA	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Knee Score	The Oxford Knee Score (OKS, best to worst 0-48) measures pain intensity and functional limitation of the knee during various activities. The questionnaire consists of 12 items. The maximum total score is 60 and corresponds with the highest pain intensity and functional limitation.	3-months post-operative
Oxford Knee Score	The Oxford Knee Score (OKS, best to worst 0-48) measures pain intensity and functional limitation of the knee during various activities. The questionnaire consists of 12 items. The maximum total score is 60 and corresponds with the highest pain intensity and functional limitation.	12-months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life-Index	European Quality of Life-questionnaire-5-dimension-3-level (worst to best, -0.329 to 1.000)	Pre-operative, 3-months and 12-months post-operative.
Symptoms	Western Ontario and McMaster Universities Osteoarthritis Index (worst to best 0-100)	Pre-operative, 3-months and 12-months post-operative.
Pain Catastrophizing	Pain Catastrophizing Scale (best to worst, 0-52)	Pre-operative, 3-months and 12-months post-operative.
Pain Sensitivity	Pain Sensitivity Questionnaire (best to worst, 0-140)	Pre-operative, 3-months and 12-months post-operative.
Mobility	De Morten Mobility index (worst to best, 0-100)	Pre-operative, 3-months and 12-months post-operative.
Complications	Registered complications during hospitalization	During in-patient stay for indicated surgery (up to 5 days)
Duration of surgery	Registered duration of surgery	During surgery
Blood loss	Registered blood loss during hospitalization	During surgery
Length of hospital stay	Duration from patient intake until discharge	During in-patient stay for indicated surgery (up to 5 days)
Anesthesia	Type of anesthesia used	During surgery
Stability of the knee	Ligament tension, assessed by the ROSA Knee System	Immediately after the surgery
Knee implant position	Resection, assessed by the ROSA Knee System	Immediately after the surgery
Mobility of the knee	Flexion, Extension of knee, assessed by the ROSA Knee System	During and immediately after the surgery
Mechanical axis of the leg.	Hip-Knee-Alignment, by CT	3-months post-surgery
Implant Survival	Duration until failure (required revision)	90-day and 1-year
Patient Survival	Duration until death	90-day and 1-year
Physical Activity	Steps per day, assessed for 7 continuous days using hip-worn accelerometer	Pre-operative, 3-months and 12-months post-operative.
Metabolic Syndrome	Metabolic Syndrome Severity Scale (no predefined range, higher scores indicate worse outcome)	Pre-operative, 3-months and 12-months post-operative.
Body composition	Fat mass, measured as % using bioimpedance analysis	Pre-operative, 3-months and 12-months post-operative.
Handgrip strength	handgrip strength using hand-held dynamometer	Pre-operative, 3-months and 12-months post-operative.
Physical condition	Completed distance in 2-minute walking	Pre-operative, 3-months and 12-months post-operative.
Physical strength	Completed sit-to-stand-transfers within 30 seconds	Pre-operative, 3-months and 12-months post-operative.
Physical mobility	Time to stand up, walk 3m back and forth and sit down again (timed-up-and-go test)	Pre-operative, 3-months and 12-months post-operative.
Cost of procedure, implants	Number implant sizes readily available, and used	During Surgery
Cost of procedure, personnel	Number of Personnel during surgery	During Surgery
Productivity	Institute for Medical Technology Assessment Productivity Cost Questionnaire (worst to best, 0-100)	Pre-operative, 3-months and 12-months post-operative.
Medical consumption	Institute for Medical Technology Assessment Medical Consumption Questionnaire (outcome in Euro)	Pre-operative, 3-months and 12-months post-operative.
Work Ability Index	Work Ability Index Questionnaire (worst to best, 0-100)	Pre-operative, 3-months and 12-months post-operative.
Work Productivity and Activity Impairment	Work Productivity and Activity Impairment-Questionnaire (worst to best, 0-100)	Pre-operative, 3-months and 12-months post-operative.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait, walking	comfortable walking speed	Pre-operative, 12-months post-operative
Gait, sit-to-stand	ground reaction force difference between left and right foot during sit-to-stand-transfer	Pre-operative, 12-months post-operative
Gait, single-leg-stance	standard deviation in center of mass and pressure during single-leg-stance	Pre-operative, 12-months post-operative
Proprioception, reaction time	Proprioception of the knee will be measured in a motorized carriage. Patients will lay on a hospital bed where their leg is fixed in the motorized carriage. This sled will passively extend and flex the knee. When patients get the sensation of movement, they have to push a button. The reaction time and the angle to sense the movement will be measured digitally.	Pre-operative, 12-months post-operative
Proprioception, angle at movement	Proprioception of the knee will be measured in a motorized carriage. Patients will lay on a hospital bed where their leg is fixed in the motorized carriage. This sled will passively extend and flex the knee. When patients get the sensation of movement, they have to push a button. The reaction time and the angle to sense the movement will be measured digitally.	Pre-operative, 12-months post-operative

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Jasper Most, PhD, Zuyderland Medical Center; Principal Investigator: Bert Boonen, PhD, Zuyderland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Gait; Metabolic Syndrome; Cost-effectiveness; Knee arthroplasty; Robotic-assisted arthroplasty; ROSA Knee System
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Z2021179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No