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

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: Enrolling by invitation
• Conditions: Knee Arthritis Osteoarthritis
• Intervention / Treatment: Other: preoperative HKA; Other: preoperative Oxford Knee Score; Other: preoperative Forgotten Joint Score; Other: preoperative range-of-motion; Other: postoperative HKA; Other: postoperative CPAK; Other: postoperative range-of-motion; Other: postoperative Oxford Knee Score; Other: postoperative Forgotten Joint Score; Other: preoperative CPAK

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: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Oxford Knee Score	before and 3,6,12 months after surgery
Forgotten Joint Score	before and 3,6,12 moths after surgery

Collaborators and Investigators

• Sponsor: Jan Biziel University Hospital No 2 in Bydgoszcz
• Collaborators: Charles University, Czech Republic; University Hospital Kralovske Vinohrady
• Investigators: 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, University Hospital Královské Vinohrady; Principal Investigator: Jakub Maléř, University Hospital Královské Vinohrady

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Actual): January 10, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KEL 12/2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No