Results Between Robotic-assisted and Manual Total Knee Arthroplasty With Kinematic Alignment (TKA TKR)

Results Between Robotic-Assisted and Manual Total Knee Arthroplasty With Kinematic Alignment

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 manual TKR or 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: Active, not recruiting
• Conditions: Knee Arthritis, Osteoarthritis
• Intervention / Treatment: Other: preoperative HKA; Other: preoperative CPAK; 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

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 manual TKR or 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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kornela Ujejskiego 75
    • Bydgoszcz, Kornela Ujejskiego 75, 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

Description

Inclusion Criteria:

• gonarthrosis

Exclusion Criteria:

• heavy systemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: manual TKA; We prepare TKA using manual intrumentation	Other: preoperative HKA; assess preoperative HKA; Other: preoperative CPAK; assess preoperative CPAK; 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: robotic assisted TKA; We prepare TKA using robotic arm	Other: preoperative HKA; assess preoperative HKA; Other: preoperative CPAK; assess preoperative CPAK; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HKA angle		3,6, 12 moths after surgery
HKA angle	measure pre and postoperative HKA angle	3,6,12 months after surgery

Collaborators and Investigators

• Sponsor: Jakub Błaszczyk
• Investigators: Study Chair: Michał Kułakowski, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz; Study Chair: Karol Elster, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz; Principal Investigator: Jakub Błaszczyk, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 1, 2026
• First Submitted That Met QC Criteria: March 1, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID 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