Knee Arthritis, OsteoarthritisTKA TKRNCT07452809
Results Between Robotic-assisted and Manual Total Knee Arthroplasty With Kinematic Alignment
A study testing preoperative HKA, preoperative CPAK and preoperative Oxford Knee Score in people with Knee Arthritis, Osteoarthritis, run by Jakub Błaszczyk at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis, Osteoarthritis
- What is being tested?
- preoperative HKA, preoperative CPAK and preoperative Oxford Knee Score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 17 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- gonarthrosis
Who cannot join
- heavy systemic diseases
Trial locations and contacts
1 site in 1 country.
Poland1 site
Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
Bydgoszcz, Kornela Ujejskiego 75, 85-168
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Arthritis, Osteoarthritis
- Being tested
- preoperative HKA, preoperative CPAK, preoperative Oxford Knee Score, preoperative Forgotten Joint Score, preoperative range-of-motion
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative HKAOther
assess preoperative HKA
preoperative CPAKOther
assess preoperative CPAK
preoperative Oxford Knee ScoreOther
assess preoperative Oxford Knee Score
preoperative Forgotten Joint ScoreOther
assess preoperative Forgotten Joint Score
preoperative range-of-motionOther
assess preoperative range-of-motion
postoperative HKAOther
postoperative HKA
postoperative CPAKOther
postoperative CPAK
postoperative range-of-motionOther
postoperative range-of-motion
postoperative Oxford Knee ScoreOther
postoperative Oxford Knee Score
postoperative Forgotten Joint ScoreOther
postoperative Forgotten Joint Score
| Study group | Role | What they receive |
|---|---|---|
| manual TKA | Other | We prepare TKA using manual intrumentation Receives: 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 |
| robotic assisted TKA | Other | We prepare TKA using robotic arm Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HKA angle
Measured: 3,6, 12 moths after surgery
HKA angle
measure pre and postoperative HKA angle
Measured: 3,6,12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start17 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthritis, OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jakub Błaszczyk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakub Błaszczyk, Jan Biziel University Hospital No 2 in Bydgoszcz
- Investigators
- Michał Kułakowski, Study chair, Dr. Jan Biziel University Hospital No. 2 in BydgoszczKarol Elster, Study chair, Dr. Jan Biziel University Hospital No. 2 in BydgoszczJakub Błaszczyk, Principal investigator, Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452809
- Sponsor's protocol ID
- KEWL 38/2025
- Acronym
- TKA TKR
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results Between Robotic-Assisted and Manual Total Knee Arthroplasty With Kinematic Alignment
- ClinicalTrials.gov ID
- NCT07452809
- Acronym / sponsor ID
- TKA TKR / KEWL 38/2025
- Conditions
- Knee Arthritis, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jakub BłaszczykUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual TKA | Other | 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 ScoreWe prepare TKA using manual intrumentation |
| robotic assisted TKA | Other | 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 ScoreWe prepare TKA using robotic arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- gonarthrosis
Key exclusion criteria (1 listed)
- heavy systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative HKAassess preoperative HKA | Other | manual TKA, robotic assisted TKA |
| preoperative CPAKassess preoperative CPAK | Other | manual TKA, robotic assisted TKA |
| preoperative Oxford Knee Scoreassess preoperative Oxford Knee Score | Other | manual TKA, robotic assisted TKA |
| preoperative Forgotten Joint Scoreassess preoperative Forgotten Joint Score | Other | manual TKA, robotic assisted TKA |
| preoperative range-of-motionassess preoperative range-of-motion | Other | manual TKA, robotic assisted TKA |
| postoperative HKApostoperative HKA | Other | manual TKA, robotic assisted TKA |
| postoperative CPAKpostoperative CPAK | Other | manual TKA, robotic assisted TKA |
| postoperative range-of-motionpostoperative range-of-motion | Other | manual TKA, robotic assisted TKA |
| postoperative Oxford Knee Scorepostoperative Oxford Knee Score | Other | manual TKA, robotic assisted TKA |
| postoperative Forgotten Joint Scorepostoperative Forgotten Joint Score | Other | manual TKA, robotic assisted TKA |
Primary outcome
HKA angle
Time frame: 3,6, 12 moths after surgery
HKA angle
Time frame: 3,6,12 months after surgery
measure pre and postoperative HKA angle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michał Kułakowski study chair
Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
Karol Elster study chair
Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
Jakub Błaszczyk principal investigator
Dr. Jan Biziel University Hospital No. 2 in Bydgoszcz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative HKA, preoperative CPAK and preoperative Oxford Knee Score in people with Knee Arthritis, Osteoarthritis, run by Jakub Błaszczyk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HKA angle (time frame: 3,6, 12 moths after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.