Osteoarthritis, KneeNCT04724915
Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing
A study testing Conventional Total Knee Arthroplasty and Robot-Assisted Total Knee Arthroplasty in people with Osteoarthritis, Knee, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Conventional Total Knee Arthroplasty and Robot-Assisted Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2020to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage osteoarthritis of the knee joint with failed conservative treatment
Who cannot join
- Previous ligament trauma of the MCL/LCL
- Previous fracture of femur or tibia
- Fixed flexion contracture > 10°
- Flexion < 110°
- Coronal deformity > 15°
- Previous infection of the knee joint
- Ligament insufficiency
- Neurologic conditions
Trial locations and contacts
1 site in 1 country.
About this study
The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Conventional Total Knee Arthroplasty, Robot-Assisted Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Total Knee ArthroplastyProcedure or surgery
People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with manual instrumentarium (jig-based).
Robot-Assisted Total Knee ArthroplastyProcedure or surgery
People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with the help of a surgical robot.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted TKA | Experimental | Patients undergoing TKA with the assistance of robot technology. Receives: Procedure: Robot-Assisted Total Knee Arthroplasty |
| Conventional TKA | Active comparator | Patients undergoing TKA with manual instrumentarium Receives: Procedure: Conventional Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Laxity
Coronal knee laxity will be evaluated with stress examination. Coronal stress will be evaluated with a stress radiograph. The deviation between the neutral position and position under stress will be measured on a coronal radiograph. The angle between the joint lines will be measured on the coronal radiograph.
Measured: Preoperative and postoperatively at 1 year.
Secondary outcomes (12)
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems
Measured: Preoperative
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Preoperative
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Preoperative
Patient reported outcome measures
The following patient reported outcome measures will be evaluated: Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 52 representing extreme problems.
Measured: Preoperative
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Forgotten Joint Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Injury and Osteoarthritis outcome score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Knee Society Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): EuroQoL. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
The change for the following patient reported outcome measures will be evaluated (compared to preoperatively): Pain Catastrophizing Scale. The score is a percentage score from 0 to 52, 0 representing no problems and 100 representing extreme problems.
Measured: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Alignment
Coronal alignment on xrays. The lateral distal femoral angle (LDFA) will be evaluated. This is the angle between the mechanical femoral axis and the line between the distal articular surface of the femur. Additionally the medial proximal tibial angle (MPTA) will be evaluated. This is the line between the condylar surface and the mechanical axis of the tibia on a coronal radiograph.
Measured: Preoperative and postoperatively at 6 weeks and 6 months.
Knee laxity anteroposterior
Sagittal knee laxity will be evaluated with stress examination. Sagittal knee laxity will be measured with an anteroposterior laxitymeter (GENOUROB; CE Marked). With a standardized setup, anteroposterior laxity can be obtained by measuring the anteroposterior deviation from the neutral position with up to 300 Newton of force.
Measured: Preoperative and postoperatively at 1 year.
Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.
Knee kinematics in 3D obtained with fluoroscopy. Patients will be asked to perform squats, a flexion/extension movement, ascend and descend stairs. 3D motion of the prosthesis components can be obtained by projecting the 3D file of the prosthesis components onto the fluoroscopy images.
Measured: Postoperatively at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Sep 2020
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
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 Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Model description
- Arm 1: Robot-assisted total knee arthroplasty Arm 2: Conventional jig-based total knee arthroplasty
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Victor, MD, PhD, Study chair, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724915
- Sponsor's protocol ID
- 2018/1281bis
- Status last verified
- Dec 2024
- First submitted
- 21 Jan 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vermue H, Arnout N, Tampere T, Stroobant L, Dereu A, Victor J. Standardized Intraoperative Robotic Laxity Assessment in TKA Leads to No Clinically Important Improvements at 2 Years Postoperatively: A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Oct 1;483(10):1866-1874. doi: 10.1097/CORR.0000000000003505. Epub 2025 Apr 16.
PubMed 40258174
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Robot-assisted Total Knee Arthroplasty with Automatic Balancing
- ClinicalTrials.gov ID
- NCT04724915
- Acronym / sponsor ID
- 2018/1281bis
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 26 Jan 2021 (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.
The goal is to evaluate the outcomes and learning curve of a robot-assisted total knee arthroplasty device with automatic ligament balancing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Arm 1: Robot-assisted total knee arthroplasty Arm 2: Conventional jig-based total knee arthroplasty
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted TKA | Experimental | Procedure: Robot-Assisted Total Knee ArthroplastyPatients undergoing TKA with the assistance of robot technology. |
| Conventional TKA | Active comparator | Procedure: Conventional Total Knee ArthroplastyPatients undergoing TKA with manual instrumentarium |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End stage osteoarthritis of the knee joint with failed conservative treatment
Key exclusion criteria (8 listed)
- Previous ligament trauma of the MCL/LCL
- Previous fracture of femur or tibia
- Fixed flexion contracture > 10°
- Flexion < 110°
- Coronal deformity > 15°
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 |
|---|---|---|
| Conventional Total Knee ArthroplastyPeople will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with manual instrumentarium (jig-based). | Procedure or surgery | Conventional TKA |
| Robot-Assisted Total Knee ArthroplastyPeople will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with the help of a surgical robot. | Procedure or surgery | Robot-assisted TKA |
Primary outcome
Knee Laxity
Time frame: Preoperative and postoperatively at 1 year.
Coronal knee laxity will be evaluated with stress examination. Coronal stress will be evaluated with a stress radiograph. The deviation between the neutral position and position under stress will be measured on a coronal radiograph. The angle between the joint lines will be measured on the coronal radiograph.
12 secondary outcomes
Patient reported outcome measures
Time frame: Preoperative
Patient reported outcome measures
Time frame: Preoperative
Patient reported outcome measures
Time frame: Preoperative
Patient reported outcome measures
Time frame: Preoperative
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Change in patient reported outcome measures
Time frame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Alignment
Time frame: Preoperative and postoperatively at 6 weeks and 6 months.
Knee laxity anteroposterior
Time frame: Preoperative and postoperatively at 1 year.
Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.
Time frame: Postoperatively at 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 40258174Vermue H, Arnout N, Tampere T, Stroobant L, Dereu A, Victor J. Standardized Intraoperative Robotic Laxity Assessment in TKA Leads to No Clinically Important Improvements at 2 Years Postoperatively: A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Oct 1;483(10):1866-1874. doi: 10.1097/CORR.0000000000003505. Epub 2025 Apr 16.
- Individual participant dataSharing planned: No
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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.
Jan Victor, MD, PhD study chair
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Total Knee Arthroplasty and Robot-Assisted Total Knee Arthroplasty in people with Osteoarthritis, Knee, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 9 Dec 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee Laxity (time frame: Preoperative and postoperatively at 1 year.). 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 NCT04724915, 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 9 Dec 2024.