Knee OsteoarthritisTKA in varusNCT07465484
Total Knee Arthroplasty in Varus Deformity
A study testing Total knee arthroplasty using active robotic surgical system in people with Knee Osteoarthritis and Knee Osteoarthritis in Varus, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
For the first time, a comparative analysis of the limb axis in patients with unilateral knee OA will be conducted compared to the contralateral uninjured side using Multisliced computed tomography (MSCT) and vertical CT (weight-bearing CT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Osteoarthritis in Varus
- What is being tested?
- Total knee arthroplasty using active robotic surgical system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2024to 31 Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with grade 3-4 knee osteoarthritis (according to Kellgren-Lawrence) and pain score of 5 or higher on a 10-point VAS scale.
- Varus deformity of the lower limb (HKA angle <177°, or varus >3°)
- Anesthesia risk according to the ASA scale of no more than III.
- BMI less than 35 kg/m2.
- Patient must be monitored throughout the entire study period (12 months).
- Patient must be mentally competent and compliant.
- Patient must provide written informed consent to participate in the study.
Who cannot join
- Body mass index > 40 kg/m².
- Instability of the collateral ligaments of the knee joint requiring the installation of ligamentous systems, presence of primary severe bone defects.
- Impaired weight-bearing ability of the contralateral limb.
- Presence of metal implants or foreign bodies in the lower extremities.
- Previous knee interventions, such as reconstruction of the knee ligament apparatus, or corrective osteotomies of the femur and tibia.
- Patient refusal to participate in the study.
- Patient failure to comply with the recommendations of the treating physician or the prescribed regimen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Moscow, 119991
Alexey Lychagin, 89166389545, clinic@travma.moscow
Konstantin Tomboidi, 8-919-737-25-43, tomboidi@mail.ru
About this study
For the first time, a comparative analysis of the limb axis in patients with unilateral knee OA will be conducted compared to the contralateral uninjured side using Multisliced computed tomography (MSCT) and vertical CT (weight-bearing CT). This analysis will identify the pathological and physiological degrees of varus in patients with unilateral gonarthrosis. Indications for mechanical and kinematic limb axis alignment will be substantiated depending on the degree of varus deformity. Aim of the study: To improve the results of total knee arthroplasty in patients with varus deformity by optimizing the degree of varus correction. Objectives: To analyze physiological and pathological varus in patients with unilateral osteoarthritis under physiological loading. To develop an algorithm for applying various types of limb alignment.
- Conditions
- Knee Osteoarthritis, Knee Osteoarthritis in Varus
- Being tested
- Total knee arthroplasty using active robotic surgical system
- Keywords
- Kinematic and Mechanical alignment, Weight-bearing CT
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty using active robotic surgical systemProcedure or surgery
Total knee arthroplasty using active robotic surgical system
Total knee arthroplasty using active robotic surgical systemProcedure or surgery
Total knee arthroplasty using active robotic surgical system
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty using the active robotic system using the kinematic alignment concept | Active comparator | Total knee arthroplasty in varus Receives: Procedure: Total knee arthroplasty using active robotic surgical system |
| Total Knee Arthroplasty using the active robotic system using the mechanical alignment concept | Active comparator | Total knee arthroplasty in varus Receives: Procedure: Total knee arthroplasty using active robotic surgical system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant position assessment
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
Measured: 2 months postoperatively
Implant position assessment
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
Measured: 6 months postoperativley
Implant position assessment
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
Measured: 12 months postoperatively
Secondary outcomes (5)
Quality of life and knee function assessment
Knee Society Score(KSS score), which combines subjective and objective information and separates the knee score (pain, stability, range of motion etc.) from the functional score of the patient (ability to walk, go up and down stairs)
Measured: 2,6,12 months postoperatively
Quality of life assessment (joint awareness after surgery)
FJS-12, measures the clinical outcomes focusing on joint awareness after surgery
Measured: 2,6,12 months postoperatively
Quality of life assessment (the condition of patients)
WOMAC score is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints
Measured: 2, 6, 12 months postoperatively
Pain assessment
Visual Analog Score (VAS) for pain - dynamics pain assessment
Measured: 2, 6, 12 months postoperatively
Quality of life assessment (an individual's activities of daily living)
OKS score. The OKS is a patient reported outcome measure that consists of 12 questions about an individual's activities of daily living and how they have been affected by pain over the preceding four weeks.
Measured: 2, 6, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Sep 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465484
- Sponsor's protocol ID
- 199819
- Acronym
- TKA in varus
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty in Varus Deformity
- ClinicalTrials.gov ID
- NCT07465484
- Acronym / sponsor ID
- TKA in varus / 199819
- Conditions
- Knee Osteoarthritis, Knee Osteoarthritis in Varus
- Keywords
- Kinematic and Mechanical alignment, Weight-bearing CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 12 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.
For the first time, a comparative analysis of the limb axis in patients with unilateral knee OA will be conducted compared to the contralateral uninjured side using Multisliced computed tomography (MSCT) and vertical CT (weight-bearing CT). This analysis will identify the pathological and physiological degrees of varus in patients with unilateral gonarthrosis. Indications for mechanical and kinematic limb axis alignment will be substantiated depending on the degree of varus deformity. Aim of the study: To improve the results of total knee arthroplasty in patients with varus deformity by optimizing the degree of varus correction. Objectives: To analyze physiological and pathological varus in patients with unilateral osteoarthritis under physiological loading. To develop an algorithm for applying various types of limb alignment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty using the active robotic system using the kinematic alignment concept | Active comparator | Procedure: Total knee arthroplasty using active robotic surgical systemTotal knee arthroplasty in varus |
| Total Knee Arthroplasty using the active robotic system using the mechanical alignment concept | Active comparator | Procedure: Total knee arthroplasty using active robotic surgical systemTotal knee arthroplasty in varus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years of age with grade 3-4 knee osteoarthritis (according to Kellgren-Lawrence) and pain score of 5 or higher on a 10-point VAS scale.
- Varus deformity of the lower limb (HKA angle <177°, or varus >3°)
- Anesthesia risk according to the ASA scale of no more than III.
- BMI less than 35 kg/m2.
- Patient must be monitored throughout the entire study period (12 months).
Key exclusion criteria (7 listed)
- Body mass index > 40 kg/m².
- Instability of the collateral ligaments of the knee joint requiring the installation of ligamentous systems, presence of primary severe bone defects.
- Impaired weight-bearing ability of the contralateral limb.
- Presence of metal implants or foreign bodies in the lower extremities.
- Previous knee interventions, such as reconstruction of the knee ligament apparatus, or corrective osteotomies of the femur and tibia.
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 |
|---|---|---|
| Total knee arthroplasty using active robotic surgical systemTotal knee arthroplasty using active robotic surgical system | Procedure or surgery | Total Knee Arthroplasty using the active robotic system using the kinematic alignment concept |
| Total knee arthroplasty using active robotic surgical systemTotal knee arthroplasty using active robotic surgical system | Procedure or surgery | Total Knee Arthroplasty using the active robotic system using the mechanical alignment concept |
Primary outcome
Implant position assessment
Time frame: 2 months postoperatively
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
Implant position assessment
Time frame: 6 months postoperativley
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
Implant position assessment
Time frame: 12 months postoperatively
CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint (LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant)
5 secondary outcomes
Quality of life and knee function assessment
Time frame: 2,6,12 months postoperatively
Quality of life assessment (joint awareness after surgery)
Time frame: 2,6,12 months postoperatively
Quality of life assessment (the condition of patients)
Time frame: 2, 6, 12 months postoperatively
Pain assessment
Time frame: 2, 6, 12 months postoperatively
Quality of life assessment (an individual's activities of daily living)
Time frame: 2, 6, 12 months postoperatively
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 12 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty using active robotic surgical system in people with Knee Osteoarthritis and Knee Osteoarthritis in Varus, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
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 7 inclusion and 7 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 12 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 Russia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant position assessment (time frame: 2 months postoperatively). The study lists 3 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 12 Mar 2026.