Comparison Between Velys J&J Robotic-assisted and Cori S&N Robotic-assisted Total Knee Arthroplasty (TKA)

June 19, 2026 updated by: Jakub Błaszczyk, Jan Biziel University Hospital No 2 in Bydgoszcz
This randomised controlled trial will include patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the criteria that consent to be in the study will be randomised at a ratio of 1:1 to either Velys J&J robotic-assisted or Cori S&N robotic-assisted TKR. The primary objective will assess pre- and postoperative HKA angle, CPAK and range of motion using goniometer to compare two groups.The secondary objectives are to compare patient expectation, functional ability, quality of life using functional 48-point Oxford Knee Score and Forgotten joint score.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This randomised controlled trial will include patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the criteria that consent to be in the study will be randomised at a ratio of 1:1 to either Velys J&J robotic-assisted or Cori S&N robotic-assisted TKR. The primary objective will assess pre- and postoperative HKA angle, CPAK and range of motion using goniometer to compare two groups.The secondary objectives are to compare patient expectation, functional ability, quality of life using functional 48-point Oxford Knee Score and Forgotten joint score.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
        • Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

patients with end-stage osteoarthritis of the knee undergoing primary TKR.

Description

Inclusion Criteria:

gonarthrosis

Exclusion Criteria:

heavy systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Velys J&J robotic assisted TKA
We prepare TKA using Velys J&J robotic arm
Other: preoperative HKA
assess preoperative HKA
Other: preoperative Oxford Knee Score
assess preoperative Oxford Knee Score
Other: preoperative Forgotten Joint Score
assess preoperative Forgotten Joint Score
Other: preoperative range-of-motion
assess preoperative range-of-motion
Other: postoperative HKA
postoperative HKA
Other: postoperative CPAK
postoperative CPAK
Other: postoperative range-of-motion
postoperative range-of-motion
Other: postoperative Oxford Knee Score
postoperative Oxford Knee Score
Other: postoperative Forgotten Joint Score
postoperative Forgotten Joint Score
Other: preoperative CPAK
asses preoperative CPAK
Cori S&N robotic assisted TKA
We prepare TKA using Cori S&N robotic arm
Other: preoperative HKA
assess preoperative HKA
Other: preoperative Oxford Knee Score
assess preoperative Oxford Knee Score
Other: preoperative Forgotten Joint Score
assess preoperative Forgotten Joint Score
Other: preoperative range-of-motion
assess preoperative range-of-motion
Other: postoperative HKA
postoperative HKA
Other: postoperative CPAK
postoperative CPAK
Other: postoperative range-of-motion
postoperative range-of-motion
Other: postoperative Oxford Knee Score
postoperative Oxford Knee Score
Other: postoperative Forgotten Joint Score
postoperative Forgotten Joint Score
Other: preoperative CPAK
asses preoperative CPAK

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
1. HKA angle
Time Frame: before and 3,6,12 after surgery
before and 3,6,12 after surgery
CPAK
Time Frame: before and 3,6,12 months after surgery
before and 3,6,12 months after surgery
range-of-motion
Time Frame: before and 3,6,12 moths after surgery
before and 3,6,12 moths after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Oxford Knee Score
Time Frame: before and 3,6,12 months after surgery
before and 3,6,12 months after surgery
Forgotten Joint Score
Time Frame: before and 3,6,12 moths after surgery
before and 3,6,12 moths after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jan Biziel University Hospital No 2 in Bydgoszcz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charles University, Czech Republic
Vascular surgery, University hospital Královské Vinohrady, Prague

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jakub Błaszczyk, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
  • Principal Investigator: Michał Kułakowski, PhD, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
  • Principal Investigator: Karol Elster, PhD, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
  • Principal Investigator: Jiří PhD Skála-Rosenbaum, Vascular surgery, University hospital Královské Vinohrady, Prague
  • Principal Investigator: Jakub Maléř, Vascular surgery, University hospital Královské Vinohrady, Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KEWL 38/2025.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings