Osteoarthritis (OA) of the KneeNCT07522489
Imageless Navigation Versus Image-Based Navigation in Robotic-Assisted Total Knee Arthroplasty for Knee Osteoarthritis
A study testing Imageless Robotic-Assisted Total Knee Arthroplasty and Image-based Robotic-Assisted Total Knee Arthroplasty in people with Osteoarthritis (OA) of the Knee and Knee Pain Arthritis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The goal of this clinical trial is to learn if imageless navigation is not inferior to image-based navigation in robotic-assisted total knee arthroplasty (RA-TKA) for treating patients with knee osteoarthritis. The main questions the study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee, Knee Pain Arthritis, Total Knee Arthroplasty (TKA)
- What is being tested?
- Imageless Robotic-Assisted Total Knee Arthroplasty and Image-based Robotic-Assisted Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 sitePoland
- Study dates
- 6 Aug 2026to Jan 2029
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic, radiologically confirmed advanced osteoarthritis of the knee.
- Patients referred for primary robotic-assisted total knee arthroplasty.
- Patients in whom a correctly performed radiograph with designated sensors has confirmed the possibility of performing robotic-assisted total knee arthroplasty with image-based navigation.
- Patients capable of giving informed consent to participate in the study and willing to attend all follow-up visits.
Who cannot join
- No informed consent for the surgery.
- No informed consent for taking part in the study.
- Pregnancy.
- Active infections.
- Diagnosed comorbidities: autoimmune arthritis, malignant tumors, serious neurological disorders affecting a reliable functional outcome measurement (e.g., severe stroke, severe Parkinson's disease).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Orthopedics and Locomotor Traumatology, Medical University of Warsaw
Warsaw, Mazovian, 02-005
Paweł Kasprzak, MD, 22 50 21 514 ext. +48, pawel.kasprzak@wum.edu.pl
Paweł Łęgosz, MD, Professor
About this study
Official title: Outcomes of Robotic-Assisted Total Knee Arthroplasty With Imageless Navigation Versus Image-Based Navigation: A Randomised, Single-Blinded, Non-Inferiority Trial
The goal of this clinical trial is to learn if imageless navigation is not inferior to image-based navigation in robotic-assisted total knee arthroplasty (RA-TKA) for treating patients with knee osteoarthritis.
The main questions the study aims to answer are:
Read more
- Does imageless procedure provide functional results comparable to those of image-based navigation?
- Are there differences in postoperative complications patients may experience after RA-TKA with imageless and image-based navigation? Researchers will compare imageless navigation with image-based navigation used in total knee arthroplasty to assess whether imageless navigation is comparable for the treatment of knee osteoarthritis.
Participants will:
- Answer survey questions about knee pain and function before RA-TKA.
- Undergo RA-TKA with imageless navigation or image-based navigation.
- Visit the Clinic after 6 months and 12 months after surgery for checkups and to answer the same survey questions about postoperative knee pain and function.
Read the detailed description
The trial will include patients with end-stage osteoarthritis, qualified for Robotic-Assisted Total Knee Arthroplasty (RA-TKA). For each patient, a full-length standing radiograph will be taken with designated sensors. Based on these, a three-dimensional model of the knee joint will be generated, enabling preoperative planning and intraoperative navigation in the image-based mode. Patients who meet the criteria and provide informed consent will be included in the study. Immediately before surgery, patients will be randomly assigned by a computer programme to either the experimental or control group in a 1:1 ratio, remaining blinded to the chosen method. In the experimental group, RA-TKA will be performed using imageless navigation, whereas in the control group, it will be performed using image-based navigation. In both groups, the procedure will be performed by experienced specialists with several years of experience, according to a standardized protocol: a medial parapatellar approach with restricted kinematic alignment, using a medial congruent knee implant.
The total number of patients included in the study is planned to be 146, with 73 in the experimental group and 73 in the control group. The group size was calculated based on a power analysis; power level: 80%, significance level: α=0.05, minimal clinically important difference: 5 points on the Oxford Knee Score (OKS), standard deviation: 10 points on the OKS. The study's dropout rate is estimated at 15%.
Radiologic imaging, survey responses, and intraoperative records will be stored on physical disks and paper, as well as in a secure cloud-based database. All other records will be stored digitally only. Registry data will be compared with external data sources (medical records) every 6 months to assess their accuracy and completeness. A Linear Mixed-Effects Model will be used to account for correlation between OKS measurements in the same patient. Both Per-Protocol and Intention-to-Treat analyses will be reported. For comparing continuous variables, a t-test (if normally distributed) or a Mann-Whitney U test (if skewed) will be used. Categorical variables will be compared with Fisher's Exact Test or the Chi-squared test. A cost-minimization analysis will be conducted using economic data.
- Conditions
- Osteoarthritis (OA) of the Knee, Knee Pain Arthritis, Total Knee Arthroplasty (TKA), Robotic Assisted Arthroplasty
- Being tested
- Imageless Robotic-Assisted Total Knee Arthroplasty, Image-based Robotic-Assisted Total Knee Arthroplasty
- Keywords
- Knee Osteoarthritis, Robotic-Assisted Total Knee Arthroplasty, Patient Reported Outcome Measures, Imageless Navigation, Image-based Navigation
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imageless Robotic-Assisted Total Knee ArthroplastyProcedure or surgery
Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Imageless Navigation
Image-based Robotic-Assisted Total Knee ArthroplastyProcedure or surgery
Patients undergoing Robotic-Assisted Total Knee Arthroplasty with Image-based Navigation
| Study group | Role | What they receive |
|---|---|---|
| Imageless Robotic Navigation | Active comparator | Not described Receives: Procedure: Imageless Robotic-Assisted Total Knee Arthroplasty |
| Image-based Robotic Navigation | Active comparator | Not described Receives: Procedure: Image-based Robotic-Assisted Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcome Measures assessed with the Oxford Knee Score
Zero is equivalent to the worst possible function of the joint and 48 indicates the best achievable function.
Measured: Survey taken right before surgery, at 6 months, and at 12 months after surgery.
Secondary outcomes (10)
Range of motion
Measured according to the neutral-zero method with a 360-degree goniometer.
Measured: On admission to the hospital, at 6 months, and at 12 months postoperatively.
Number of Participants achieving a planned postoperative limb alignment
The percentage of patients within ±3 degrees of the preoperative target.
Measured: From enrollment to 12 months after surgery.
Postoperative radiographic results
Hip-Knee-Ankle angle, mechanical axis deviation, coronal femoral component angle (mechanical lateral distal femoral angle, mechanical lateral proximal femoral angle), sagittal femoral tilt/flexion, coronal tibial component angle (mechanical/anatomical lateral distal tibial angle, mechanical/anatomical medial proximal tibial angle) posterior tibial slope, joint line convergence angle, all measured in degrees
Measured: From enrollment to 12 months after surgery.
Postoperative pain assessed with a VAS scale
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: Survey taken right before surgery, at 6 months, and at 12 months after surgery.
Time of the surgical procedure
Duration of the surgical procedure in total and for each stage measured in minutes.
Measured: From the beginning to the end of the surgical procedure.
Estimation of perioperative blood loss
Intra-operative blood loss estimation by measuring the blood volume accumulated in suction bottles in milliliters, taking into account the volume of saline solution used during the surgery.
Measured: Immediately after the end of the surgery.
Difference between preoperative and postoperative hemoglobin levels
Hemoglobin levels will be obtained from samples taken at different times before and after surgery.
Measured: Hemoglobin levels will be measured within 2 weeks before surgery, as well as 24, 48 and 72 hours after surgery.
Postoperative complications
The percentage of cases with reported postoperative complications, such as: bleeding, wound complication, thromboembolic disease, neural deficit, vascular injury, ligament injury, instability, malalignment, stiffness, periprosthetic joint infection, periprosthetic fracture, extensor mechanism disruption, dislocation, bearing surface wear, osteolysis, implant loosening, revision, death.
Measured: From enrollment to 12 months after surgery.
Costs required for preoperative planning
Costs of all preoperative imaging and procedures necessary to plan imageless and image-based robotic navigation.
Measured: From one month before enrollment to 12 months after surgery.
Time required for preoperative planning
Time required to prepare all preoperative imaging and procedures necessary to plan imageless and image-based robotic navigation.
Measured: From one month before enrollment to 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 posted13 Apr 2026
- Study start6 Aug 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paweł Łęgosz, MD, Professor, Principal investigator, Medical University of WarsawŁukasz Pulik, MD, PhD, Principal investigator, Medical University of WarsawPaweł Kasprzak, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522489
- Sponsor's protocol ID
- KB/178/2025
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study results will be disseminated in conference abstracts and peer-reviewed journal articles.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Robotic-Assisted Total Knee Arthroplasty With Imageless Navigation Versus Image-Based Navigation: A Randomised, Single-Blinded, Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07522489
- Acronym / sponsor ID
- KB/178/2025
- Conditions
- Osteoarthritis (OA) of the Knee, Knee Pain Arthritis, Total Knee Arthroplasty (TKA), Robotic Assisted Arthroplasty
- Keywords
- Knee Osteoarthritis, Robotic-Assisted Total Knee Arthroplasty, Patient Reported Outcome Measures, Imageless Navigation, Image-based Navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 13 Apr 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.
The goal of this clinical trial is to learn if imageless navigation is not inferior to image-based navigation in robotic-assisted total knee arthroplasty (RA-TKA) for treating patients with knee osteoarthritis.
The main questions the study aims to answer are:
- Does imageless procedure provide functional results comparable to those of image-based navigation?
- Are there differences in postoperative complications patients may experience after RA-TKA with imageless and image-based navigation? Researchers will compare imageless navigation with image-based navigation used in total knee arthroplasty to assess whether imageless navigation is comparable for the treatment of knee osteoarthritis.
Participants will:
- Answer survey questions about knee pain and function before RA-TKA.
- Undergo RA-TKA with imageless navigation or image-based navigation.
- Visit the Clinic after 6 months and 12 months after surgery for checkups and to answer the same survey questions about postoperative knee pain and function.
Detailed description
The trial will include patients with end-stage osteoarthritis, qualified for Robotic-Assisted Total Knee Arthroplasty (RA-TKA). For each patient, a full-length standing radiograph will be taken with designated sensors. Based on these, a three-dimensional model of the knee joint will be generated, enabling preoperative planning and intraoperative navigation in the image-based mode. Patients who meet the criteria and provide informed consent will be included in the study. Immediately before surgery, patients will be randomly assigned by a computer programme to either the experimental or control group in a 1:1 ratio, remaining blinded to the chosen method. In the experimental group, RA-TKA will be performed using imageless navigation, whereas in the control group, it will be performed using image-based navigation. In both groups, the procedure will be performed by experienced specialists with several years of experience, according to a standardized protocol: a medial parapatellar approach with restricted kinematic alignment, using a medial congruent knee implant.
The total number of patients included in the study is planned to be 146, with 73 in the experimental group and 73 in the control group. The group size was calculated based on a power analysis; power level: 80%, significance level: α=0.05, minimal clinically important difference: 5 points on the Oxford Knee Score (OKS), standard deviation: 10 points on the OKS. The study's dropout rate is estimated at 15%.
Radiologic imaging, survey responses, and intraoperative records will be stored on physical disks and paper, as well as in a secure cloud-based database. All other records will be stored digitally only. Registry data will be compared with external data sources (medical records) every 6 months to assess their accuracy and completeness. A Linear Mixed-Effects Model will be used to account for correlation between OKS measurements in the same patient. Both Per-Protocol and Intention-to-Treat analyses will be reported. For comparing continuous variables, a t-test (if normally distributed) or a Mann-Whitney U test (if skewed) will be used. Categorical variables will be compared with Fisher's Exact Test or the Chi-squared test. A cost-minimization analysis will be conducted using economic data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imageless Robotic Navigation | Active comparator | Procedure: Imageless Robotic-Assisted Total Knee Arthroplasty |
| Image-based Robotic Navigation | Active comparator | Procedure: Image-based Robotic-Assisted Total Knee Arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic, radiologically confirmed advanced osteoarthritis of the knee.
- Patients referred for primary robotic-assisted total knee arthroplasty.
- Patients in whom a correctly performed radiograph with designated sensors has confirmed the possibility of performing robotic-assisted total knee arthroplasty with image-based navigation.
- Patients capable of giving informed consent to participate in the study and willing to attend all follow-up visits.
Key exclusion criteria (5 listed)
- No informed consent for the surgery.
- No informed consent for taking part in the study.
- Pregnancy.
- Active infections.
- Diagnosed comorbidities: autoimmune arthritis, malignant tumors, serious neurological disorders affecting a reliable functional outcome measurement (e.g., severe stroke, severe Parkinson's disease).
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 |
|---|---|---|
| Imageless Robotic-Assisted Total Knee ArthroplastyPatients undergoing Robotic-Assisted Total Knee Arthroplasty with Imageless Navigation | Procedure or surgery | Imageless Robotic Navigation |
| Image-based Robotic-Assisted Total Knee ArthroplastyPatients undergoing Robotic-Assisted Total Knee Arthroplasty with Image-based Navigation | Procedure or surgery | Image-based Robotic Navigation |
Primary outcome
Patient-Reported Outcome Measures assessed with the Oxford Knee Score
Time frame: Survey taken right before surgery, at 6 months, and at 12 months after surgery.
Zero is equivalent to the worst possible function of the joint and 48 indicates the best achievable function.
10 secondary outcomes
Range of motion
Time frame: On admission to the hospital, at 6 months, and at 12 months postoperatively.
Number of Participants achieving a planned postoperative limb alignment
Time frame: From enrollment to 12 months after surgery.
Postoperative radiographic results
Time frame: From enrollment to 12 months after surgery.
Postoperative pain assessed with a VAS scale
Time frame: Survey taken right before surgery, at 6 months, and at 12 months after surgery.
Time of the surgical procedure
Time frame: From the beginning to the end of the surgical procedure.
Estimation of perioperative blood loss
Time frame: Immediately after the end of the surgery.
Difference between preoperative and postoperative hemoglobin levels
Time frame: Hemoglobin levels will be measured within 2 weeks before surgery, as well as 24, 48 and 72 hours after surgery.
Postoperative complications
Time frame: From enrollment to 12 months after surgery.
Costs required for preoperative planning
Time frame: From one month before enrollment to 12 months after surgery.
Time required for preoperative planning
Time frame: From one month before enrollment to 12 months after surgery.
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 13 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified study results will be disseminated in conference abstracts and peer-reviewed journal articles.
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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.
Paweł Łęgosz, MD, Professor principal investigator
Medical University of Warsaw
Łukasz Pulik, MD, PhD principal investigator
Medical University of Warsaw
Paweł Kasprzak, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imageless Robotic-Assisted Total Knee Arthroplasty and Image-based Robotic-Assisted Total Knee Arthroplasty in people with Osteoarthritis (OA) of the Knee and Knee Pain Arthritis, run by Medical University of Warsaw 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Aug 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?
Contact Paweł Kasprzak, MD (22 50 21 514 ext. +48, pawel.kasprzak@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcome Measures assessed with the Oxford Knee Score (time frame: Survey taken right before surgery, at 6 months, and at 12 months after surgery.). 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 13 Aug 2026.