ROSA Knee System vs Conventional Total Knee Arthroplasty

NCT05685693 | Active Not Recruiting DMC

• 1 other identifier: Z2021179
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Robotic-assisted arthroplasty; Knee arthroplasty; Gait; Metabolic Syndrome; ROSA Knee System; Physical Activity; Cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (29)

• Quality of Life-Index

  Pre-operative, 3-months and 12-months post-operative.

• Symptoms

  Pre-operative, 3-months and 12-months post-operative.

• Pain Catastrophizing

  Pre-operative, 3-months and 12-months post-operative.

• Pain Sensitivity

  Pre-operative, 3-months and 12-months post-operative.

• Mobility

  Pre-operative, 3-months and 12-months post-operative.

Other Outcomes (5)

• Gait, walking

  Pre-operative, 12-months post-operative

• Gait, sit-to-stand

  Pre-operative, 12-months post-operative

• Gait, single-leg-stance

  Pre-operative, 12-months post-operative

Study Arms (2)

Conventional TKA

ACTIVE COMPARATOR

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

Procedure: conventional total knee arthroplasty

Robotic-assisted TKA

EXPERIMENTAL

ROSA Knee System assisted TKA

Procedure: Robotic-assisted total knee arthroplasty (raTKA)

Interventions

Robotic-assisted total knee arthroplasty (raTKA) PROCEDURE

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.

Robotic-assisted TKA

conventional total knee arthroplasty PROCEDURE

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.

Conventional TKA

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Rheuma-/trauma-indicated knee arthroplasty

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Zuyderland Medical Center

Sittard, Limburg, 6162 BG, Netherlands

Location

Related Publications (1)

• Eijking HM, Dorling IM, van Haaren EH, Hendrickx R, Nijenhuis T, Schotanus MGM, Bouwman L, Most J, Boonen B. Image-based robotic (ROSA(R) knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty : Study protocol and the inverse kinematic alignment in 8-steps using the ROSA(R) Knee system for knee balancing technique explained. J Orthop Surg Res. 2025 Jan 15;20(1):47. doi: 10.1186/s13018-024-05427-y.

  PMID: 39815282 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Jasper Most, PhD

  Zuyderland Medical Center

  PRINCIPAL INVESTIGATOR

• Bert Boonen, PhD

  Zuyderland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: January 17, 2023
• Study Start: December 16, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2035
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)