ROSA_RCT: ROSA Knee System vs Conventional Total Knee Arthroplasty

Sponsor

Zuyderland Medisch Centrum (Other)

Overall Status

Recruiting

CT.gov ID

NCT05685693

Collaborator

Zimmer Biomet (Industry)

150

Enrollment

Location

Arms

47.5

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: Robotic-assisted total knee arthroplasty (raTKA) Procedure: conventional total knee arthroplasty	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 16, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Oxford Knee Score [3-months post-operative]
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.
Oxford Knee Score [12-months post-operative]
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.

Secondary Outcome Measures

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

Other Outcome Measures

Gait, walking [Pre-operative, 12-months post-operative]
comfortable walking speed
Gait, sit-to-stand [Pre-operative, 12-months post-operative]
ground reaction force difference between left and right foot during sit-to-stand-transfer
Gait, single-leg-stance [Pre-operative, 12-months post-operative]
standard deviation in center of mass and pressure during single-leg-stance
Proprioception, reaction time [Pre-operative, 12-months post-operative]
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.
Proprioception, angle at movement [Pre-operative, 12-months post-operative]
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.