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

NCT07452809 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • Knee Arthritis, Osteoarthritis

Interventions

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

Sponsors & Collaborators

  • Jakub Błaszczyk

    lead OTHER

Principal Investigators

  • Michał Kułakowski · Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

  • Karol Elster · Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

  • Jakub Błaszczyk · Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452809 on ClinicalTrials.gov