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
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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