Results Between Robotic-assisted and Manual Total Knee Arthroplasty With Kinematic Alignment (TKA TKR)
March 1, 2026 updated by: Jakub Błaszczyk
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kornela Ujejskiego 75
-
Bydgoszcz, Kornela Ujejskiego 75, Poland, 85-168
- Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- gonarthrosis
Exclusion Criteria:
- heavy systemic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: manual TKA
We prepare TKA using manual intrumentation
|
assess preoperative HKA
assess preoperative CPAK
assess preoperative Oxford Knee Score
assess preoperative Forgotten Joint Score
assess preoperative range-of-motion
postoperative HKA
postoperative CPAK
postoperative range-of-motion
postoperative Oxford Knee Score
postoperative Forgotten Joint Score
|
|
Other: robotic assisted TKA
We prepare TKA using robotic arm
|
assess preoperative HKA
assess preoperative CPAK
assess preoperative Oxford Knee Score
assess preoperative Forgotten Joint Score
assess preoperative range-of-motion
postoperative HKA
postoperative CPAK
postoperative range-of-motion
postoperative Oxford Knee Score
postoperative Forgotten Joint Score
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HKA angle
Time Frame: 3,6, 12 moths after surgery
|
3,6, 12 moths after surgery
|
|
|
HKA angle
Time Frame: 3,6,12 months after surgery
|
measure pre and postoperative HKA angle
|
3,6,12 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.