Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05685693

ROSA Knee System vs Conventional Total Knee Arthroplasty

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Joint Diseases Metabolic Diseases Metabolic Syndrome Motor Activity Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zuyderland Medical Center

Sittard, Limburg, 6162 BG, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Oxford Knee Score

    Time frame: 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.

  2. Oxford Knee Score

    Time frame: 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 outcomes

  1. Quality of Life-Index

    Time frame: 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)

  2. Symptoms

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Western Ontario and McMaster Universities Osteoarthritis Index (worst to best 0-100)

  3. Pain Catastrophizing

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Pain Catastrophizing Scale (best to worst, 0-52)

  4. Pain Sensitivity

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Pain Sensitivity Questionnaire (best to worst, 0-140)

  5. Mobility

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    De Morten Mobility index (worst to best, 0-100)

  6. Complications

    Time frame: During in-patient stay for indicated surgery (up to 5 days)

    Registered complications during hospitalization

  7. Duration of surgery

    Time frame: During surgery

    Registered duration of surgery

  8. Blood loss

    Time frame: During surgery

    Registered blood loss during hospitalization

  9. Length of hospital stay

    Time frame: During in-patient stay for indicated surgery (up to 5 days)

    Duration from patient intake until discharge

  10. Anesthesia

    Time frame: During surgery

    Type of anesthesia used

  11. Stability of the knee

    Time frame: Immediately after the surgery

    Ligament tension, assessed by the ROSA Knee System

  12. Knee implant position

    Time frame: Immediately after the surgery

    Resection, assessed by the ROSA Knee System

  13. Mobility of the knee

    Time frame: During and immediately after the surgery

    Flexion, Extension of knee, assessed by the ROSA Knee System

  14. Mechanical axis of the leg.

    Time frame: 3-months post-surgery

    Hip-Knee-Alignment, by CT

  15. Implant Survival

    Time frame: 90-day and 1-year

    Duration until failure (required revision)

  16. Patient Survival

    Time frame: 90-day and 1-year

    Duration until death

  17. Physical Activity

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Steps per day, assessed for 7 continuous days using hip-worn accelerometer

  18. Metabolic Syndrome

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Metabolic Syndrome Severity Scale (no predefined range, higher scores indicate worse outcome)

  19. Body composition

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Fat mass, measured as % using bioimpedance analysis

  20. Handgrip strength

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    handgrip strength using hand-held dynamometer

  21. Physical condition

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Completed distance in 2-minute walking

  22. Physical strength

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Completed sit-to-stand-transfers within 30 seconds

  23. Physical mobility

    Time frame: 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)

  24. Cost of procedure, implants

    Time frame: During Surgery

    Number implant sizes readily available, and used

  25. Cost of procedure, personnel

    Time frame: During Surgery

    Number of Personnel during surgery

  26. Productivity

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Institute for Medical Technology Assessment Productivity Cost Questionnaire (worst to best, 0-100)

  27. Medical consumption

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Institute for Medical Technology Assessment Medical Consumption Questionnaire (outcome in Euro)

  28. Work Ability Index

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Work Ability Index Questionnaire (worst to best, 0-100)

  29. Work Productivity and Activity Impairment

    Time frame: Pre-operative, 3-months and 12-months post-operative.

    Work Productivity and Activity Impairment-Questionnaire (worst to best, 0-100)

Other outcomes

  1. Gait, walking

    Time frame: Pre-operative, 12-months post-operative

    comfortable walking speed

  2. Gait, sit-to-stand

    Time frame: Pre-operative, 12-months post-operative

    ground reaction force difference between left and right foot during sit-to-stand-transfer

  3. Gait, single-leg-stance

    Time frame: Pre-operative, 12-months post-operative

    standard deviation in center of mass and pressure during single-leg-stance

  4. Proprioception, reaction time

    Time frame: 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.

  5. Proprioception, angle at movement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

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

Acronym: ROSA_RCT

Important dates

Study start
2022
Primary completion
2025
Study completion
2035
First posted
Jan 17, 2023
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.