NCT07555067

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Jan 2026Mar 2027

Study Start

First participant enrolled

January 1, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

9 days

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 1. HKA angle

    before and 3,6,12 after surgery

  • CPAK

    before and 3,6,12 months after surgery

  • range-of-motion

    before and 3,6,12 moths after surgery

Secondary Outcomes (2)

  • Oxford Knee Score

    before and 3,6,12 months after surgery

  • Forgotten Joint Score

    before and 3,6,12 moths after surgery

Study Arms (2)

Velys J&J robotic assisted TKA

We prepare TKA using Velys J\&J robotic arm

Other: preoperative HKAOther: preoperative CPAKOther: preoperative Oxford Knee ScoreOther: preoperative Forgotten Joint ScoreOther: preoperative range-of-motionOther: postoperative HKAOther: postoperative CPAKOther: postoperative range-of-motionOther: postoperative Oxford Knee ScoreOther: postoperative Forgotten Joint Score

Cori S&N robotic assisted TKA

We prepare TKA using Cori S\&N robotic arm

Other: preoperative HKAOther: preoperative CPAKOther: preoperative Oxford Knee ScoreOther: preoperative Forgotten Joint ScoreOther: preoperative range-of-motionOther: postoperative HKAOther: postoperative CPAKOther: postoperative range-of-motionOther: postoperative Oxford Knee ScoreOther: postoperative Forgotten Joint Score

Interventions

assess preoperative HKA

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

asses preoperative CPAK

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

assess preoperative Oxford Knee Score

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

assess preoperative Forgotten Joint Score

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

assess preoperative range-of-motion

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

postoperative HKA

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

postoperative CPAK

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

postoperative range-of-motion

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

postoperative Oxford Knee Score

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

postoperative Forgotten Joint Score

Cori S&N robotic assisted TKAVelys J&J robotic assisted TKA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • gonarthrosis

You may not qualify if:

  • heavy systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Study Officials

  • Michał Kułakowski, PhD

    Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

    PRINCIPAL INVESTIGATOR
  • Jakub Błaszczyk

    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

    University Hospital Kralovske Vinohrady

    PRINCIPAL INVESTIGATOR
  • Jakub Maléř

    University Hospital Kralovske Vinohrady

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start

January 1, 2026

Primary Completion

January 10, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations