ROSA Knee System vs Conventional Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

— ROSA_RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05685693
• Other study ID #: Z2021179
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2022
• Est. completion date: December 2026

Study information

• Verified date: December 2022
• Source: Zuyderland Medisch Centrum
• Contact: Jasper Most, PhD
• Phone: +31(0)625159747
• Email: j.most[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Center	Sittard	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum	Zimmer Biomet

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gait, walking	comfortable walking speed	Pre-operative, 12-months post-operative
Other	Gait, sit-to-stand	ground reaction force difference between left and right foot during sit-to-stand-transfer	Pre-operative, 12-months post-operative
Other	Gait, single-leg-stance	standard deviation in center of mass and pressure during single-leg-stance	Pre-operative, 12-months post-operative
Other	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
Other	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
Primary	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
Primary	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	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.
Secondary	Symptoms	Western Ontario and McMaster Universities Osteoarthritis Index (worst to best 0-100)	Pre-operative, 3-months and 12-months post-operative.
Secondary	Pain Catastrophizing	Pain Catastrophizing Scale (best to worst, 0-52)	Pre-operative, 3-months and 12-months post-operative.
Secondary	Pain Sensitivity	Pain Sensitivity Questionnaire (best to worst, 0-140)	Pre-operative, 3-months and 12-months post-operative.
Secondary	Mobility	De Morten Mobility index (worst to best, 0-100)	Pre-operative, 3-months and 12-months post-operative.
Secondary	Complications	Registered complications during hospitalization	During in-patient stay for indicated surgery (up to 5 days)
Secondary	Duration of surgery	Registered duration of surgery	During surgery
Secondary	Blood loss	Registered blood loss during hospitalization	During surgery
Secondary	Length of hospital stay	Duration from patient intake until discharge	During in-patient stay for indicated surgery (up to 5 days)
Secondary	Anesthesia	Type of anesthesia used	During surgery
Secondary	Stability of the knee	Ligament tension, assessed by the ROSA Knee System	Immediately after the surgery
Secondary	Knee implant position	Resection, assessed by the ROSA Knee System	Immediately after the surgery
Secondary	Mobility of the knee	Flexion, Extension of knee, assessed by the ROSA Knee System	During and immediately after the surgery
Secondary	Mechanical axis of the leg.	Hip-Knee-Alignment, by CT	3-months post-surgery
Secondary	Implant Survival	Duration until failure (required revision)	90-day and 1-year
Secondary	Patient Survival	Duration until death	90-day and 1-year
Secondary	Physical Activity	Steps per day, assessed for 7 continuous days using hip-worn accelerometer	Pre-operative, 3-months and 12-months post-operative.
Secondary	Metabolic Syndrome	Metabolic Syndrome Severity Scale (no predefined range, higher scores indicate worse outcome)	Pre-operative, 3-months and 12-months post-operative.
Secondary	Body composition	Fat mass, measured as % using bioimpedance analysis	Pre-operative, 3-months and 12-months post-operative.
Secondary	Handgrip strength	handgrip strength using hand-held dynamometer	Pre-operative, 3-months and 12-months post-operative.
Secondary	Physical condition	Completed distance in 2-minute walking	Pre-operative, 3-months and 12-months post-operative.
Secondary	Physical strength	Completed sit-to-stand-transfers within 30 seconds	Pre-operative, 3-months and 12-months post-operative.
Secondary	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.
Secondary	Cost of procedure, implants	Number implant sizes readily available, and used	During Surgery
Secondary	Cost of procedure, personnel	Number of Personnel during surgery	During Surgery
Secondary	Productivity	Institute for Medical Technology Assessment Productivity Cost Questionnaire (worst to best, 0-100)	Pre-operative, 3-months and 12-months post-operative.
Secondary	Medical consumption	Institute for Medical Technology Assessment Medical Consumption Questionnaire (outcome in Euro)	Pre-operative, 3-months and 12-months post-operative.
Secondary	Work Ability Index	Work Ability Index Questionnaire (worst to best, 0-100)	Pre-operative, 3-months and 12-months post-operative.
Secondary	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.