Knee OsteoarthritisROSA_RCTNCT05685693

ROSA Knee System vs Conventional Total Knee Arthroplasty

A study testing Robotic-assisted total knee arthroplasty (raTKA) and conventional total knee arthroplasty in people with Knee Osteoarthritis, run by Zuyderland Medisch Centrum at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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. Read more about this study

Who is it for?: Ages 40 to 90 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Robotic-assisted total knee arthroplasty (raTKA) and conventional total knee arthroplasty
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteNetherlands
Study dates: 16 Dec 2022to Dec 2035
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Rheuma-/trauma-indicated knee arthroplasty

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Zuyderland Medical Center
Sittard, Limburg, 6162 BG

Other trials in Netherlands

About this study

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

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
Being tested: Robotic-assisted total knee arthroplasty (raTKA), conventional total knee arthroplasty
Keywords: Robotic-assisted arthroplasty, Knee arthroplasty, Gait, Metabolic Syndrome, ROSA Knee System, Physical Activity, Cost-effectiveness
Medical subject headings: Osteoarthritis, Knee, Metabolic Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Robotic-assisted total knee arthroplasty (raTKA)Procedure or surgery
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 arthroplastyProcedure or surgery
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.

Study groups in NCT05685693
Study group	Role	What they receive
Conventional TKA	Active comparator	Conventional TKA, with no patient-specific instrumentation or robotic assistance Receives: Procedure: conventional total knee arthroplasty
Robotic-assisted TKA	Experimental	ROSA Knee System assisted TKA Receives: Procedure: Robotic-assisted total knee arthroplasty (raTKA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12-months post-operative

Secondary outcomes (29)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 2022Dec 2035

First posted17 Jan 2023
Study start16 Dec 2022
Primary completionDec 2025 (estimated)
Study completionDec 2035 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05685693
Sponsor's protocol ID: Z2021179
Acronym: ROSA_RCT
Status last verified: Jul 2024
First submitted: 25 Nov 2022
Last updated: 24 Jul 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39815282

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
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The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of ROSA®-Assisted Knee Arthroplasty on Clinical Outcomes
ClinicalTrials.gov ID: NCT05685693
Acronym / sponsor ID: ROSA_RCT / Z2021179
Conditions: Knee Osteoarthritis
Keywords: Robotic-assisted arthroplasty, Knee arthroplasty, Gait, Metabolic Syndrome, ROSA Knee System, Physical Activity, Cost-effectiveness
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 150 participants (actual)
Lead sponsor: Zuyderland Medisch CentrumUniversity, hospital or other
Collaborators: Zimmer Biomet
Study start: 16 Dec 2022 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2035 (estimated)
First posted: 17 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Conventional TKA	Active comparator	Procedure: conventional total knee arthroplastyConventional TKA, with no patient-specific instrumentation or robotic assistance
Robotic-assisted TKA	Experimental	Procedure: Robotic-assisted total knee arthroplasty (raTKA)ROSA Knee System assisted TKA

Who may qualify

Ages: 40 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (1 listed)

Rheuma-/trauma-indicated knee arthroplasty

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Procedure or surgery	Robotic-assisted TKA
conventional total knee arthroplastytotal 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.	Procedure or surgery	Conventional TKA

Primary outcome

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.
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.

29 secondary outcomes

Quality of Life-Index
Time frame: Pre-operative, 3-months and 12-months post-operative.
Symptoms
Time frame: Pre-operative, 3-months and 12-months post-operative.
Pain Catastrophizing
Time frame: Pre-operative, 3-months and 12-months post-operative.
Pain Sensitivity
Time frame: Pre-operative, 3-months and 12-months post-operative.
Mobility
Time frame: Pre-operative, 3-months and 12-months post-operative.
Complications
Time frame: During in-patient stay for indicated surgery (up to 5 days)
Duration of surgery
Time frame: During surgery
Blood loss
Time frame: During surgery
Length of hospital stay
Time frame: During in-patient stay for indicated surgery (up to 5 days)
Anesthesia
Time frame: During surgery
Stability of the knee
Time frame: Immediately after the surgery
Knee implant position
Time frame: Immediately after the surgery
Mobility of the knee
Time frame: During and immediately after the surgery
Mechanical axis of the leg.
Time frame: 3-months post-surgery
Implant Survival
Time frame: 90-day and 1-year
Patient Survival
Time frame: 90-day and 1-year
Physical Activity
Time frame: Pre-operative, 3-months and 12-months post-operative.
Metabolic Syndrome
Time frame: Pre-operative, 3-months and 12-months post-operative.
Body composition
Time frame: Pre-operative, 3-months and 12-months post-operative.
Handgrip strength
Time frame: Pre-operative, 3-months and 12-months post-operative.
Physical condition
Time frame: Pre-operative, 3-months and 12-months post-operative.
Physical strength
Time frame: Pre-operative, 3-months and 12-months post-operative.
Physical mobility
Time frame: Pre-operative, 3-months and 12-months post-operative.
Cost of procedure, implants
Time frame: During Surgery
Cost of procedure, personnel
Time frame: During Surgery
Productivity
Time frame: Pre-operative, 3-months and 12-months post-operative.
Medical consumption
Time frame: Pre-operative, 3-months and 12-months post-operative.
Work Ability Index
Time frame: Pre-operative, 3-months and 12-months post-operative.
Work Productivity and Activity Impairment
Time frame: Pre-operative, 3-months and 12-months post-operative.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Derived from this study: PubMed 39815282Eijking 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.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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Not yet recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jasper Most, PhD principal investigator

Zuyderland Medical Center

Bert Boonen, PhD principal investigator

Zuyderland Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxford Knee Score (time frame: 3-months post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05685693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.