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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07452809
Acronym
TKA TKR
Enrollment
100
Registered
2026-03-05
Start date
2025-12-17
Completion date
2027-12-31
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthritis, Osteoarthritis

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.

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.

Interventions

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

Sponsors

Jakub Błaszczyk
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* gonarthrosis

Exclusion criteria

* heavy systemic diseases

Design outcomes

Primary

MeasureTime frame
HKA angle3,6, 12 moths after surgery

Countries

Poland

Contacts

STUDY_CHAIRMichał Kułakowski

Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

STUDY_CHAIRKarol Elster

Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

PRINCIPAL_INVESTIGATORJakub Błaszczyk

Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026