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OpenTrials
Active, Not Recruiting

NCT Number: NCT07452809

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Arthritis, Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz

Bydgoszcz, Kornela Ujejskiego 75, 85-168, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gonarthrosis

Exclusion criteria

  • heavy systemic diseases

Treatment and study plan

preoperative HKA

Other

assess preoperative HKA

preoperative CPAK

Other

assess preoperative CPAK

preoperative Oxford Knee Score

Other

assess preoperative Oxford Knee Score

preoperative Forgotten Joint Score

Other

assess preoperative Forgotten Joint Score

preoperative range-of-motion

Other

assess preoperative range-of-motion

postoperative HKA

Other

postoperative HKA

postoperative CPAK

Other

postoperative CPAK

postoperative range-of-motion

Other

postoperative range-of-motion

postoperative Oxford Knee Score

Other

postoperative Oxford Knee Score

postoperative Forgotten Joint Score

Other

postoperative Forgotten Joint Score

Primary outcomes

  1. HKA angle

    Time frame: 3,6, 12 moths after surgery

  2. HKA angle

    Time frame: 3,6,12 months after surgery

    measure pre and postoperative HKA angle

Sponsors and collaborators

Lead sponsor

Jakub Błaszczyk

Other

Registry information

Acronym: TKA TKR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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