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
1 other identifier
interventional
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
December 17, 2025
CompletedFirst Submitted
Initial submission to the registry
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 5, 2026
February 1, 2026
2 years
March 1, 2026
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
OTHERWe prepare TKA using manual intrumentation
robotic assisted TKA
OTHERWe prepare TKA using robotic arm
Interventions
assess preoperative Oxford Knee Score
assess preoperative Forgotten Joint Score
postoperative Forgotten Joint Score
Eligibility Criteria
You may qualify if:
- gonarthrosis
You may not qualify if:
- heavy systemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jakub Błaszczyklead
Study Sites (1)
Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
Bydgoszcz, Kornela Ujejskiego 75, 85-168, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 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