NCT07452809

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 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Dec 2027

Study Start

First participant enrolled

December 17, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

March 1, 2026

Last Update Submit

March 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • HKA angle

    3,6, 12 moths after surgery

  • HKA angle

    measure pre and postoperative HKA angle

    3,6,12 months after surgery

Study Arms (2)

manual TKA

OTHER

We prepare TKA using manual intrumentation

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

robotic assisted TKA

OTHER

We prepare TKA using 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

manual TKArobotic assisted TKA

assess preoperative CPAK

manual TKArobotic assisted TKA

assess preoperative Oxford Knee Score

manual TKArobotic assisted TKA

assess preoperative Forgotten Joint Score

manual TKArobotic assisted TKA

assess preoperative range-of-motion

manual TKArobotic assisted TKA

postoperative HKA

manual TKArobotic assisted TKA

postoperative CPAK

manual TKArobotic assisted TKA

postoperative range-of-motion

manual TKArobotic assisted TKA

postoperative Oxford Knee Score

manual TKArobotic assisted TKA

postoperative Forgotten Joint Score

manual TKArobotic assisted TKA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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, Kornela Ujejskiego 75, 85-168, Poland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Michał Kułakowski

    Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

    STUDY CHAIR
  • Karol Elster

    Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

    STUDY CHAIR
  • Jakub Błaszczyk

    Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 1, 2026

First Posted

March 5, 2026

Study Start

December 17, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 5, 2026

Record last verified: 2026-02

Locations