Total Knee Arthroplasty in Varus Deformity (TKA in varus)

March 6, 2026 updated by: I.M. Sechenov First Moscow State Medical University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia, 119991
        • Recruiting
        • University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Varus deformity of the lower limb (HKA angle <177°, or varus >3°)
  3. Anesthesia risk according to the ASA scale of no more than III.
  4. BMI less than 35 kg/m2.
  5. Patient must be monitored throughout the entire study period (12 months).
  6. Patient must be mentally competent and compliant.
  7. Patient must provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Body mass index > 40 kg/m².
  2. Instability of the collateral ligaments of the knee joint requiring the installation of ligamentous systems, presence of primary severe bone defects.
  3. Impaired weight-bearing ability of the contralateral limb.
  4. Presence of metal implants or foreign bodies in the lower extremities.
  5. Previous knee interventions, such as reconstruction of the knee ligament apparatus, or corrective osteotomies of the femur and tibia.
  6. Patient refusal to participate in the study.
  7. Patient failure to comply with the recommendations of the treating physician or the prescribed regimen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Total Knee Arthroplasty using the active robotic system using the kinematic alignment concept
Total knee arthroplasty in varus
Procedure: Total knee arthroplasty using active robotic surgical system
Total knee arthroplasty using active robotic surgical system
Active Comparator: Total Knee Arthroplasty using the active robotic system using the mechanical alignment concept
Total knee arthroplasty in varus
Procedure: Total knee arthroplasty using active robotic surgical system
Total knee arthroplasty using active robotic surgical system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 months postoperatively
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)
6 months postoperativley
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)
12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life and knee function assessment
Time Frame: 2,6,12 months postoperatively
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)
2,6,12 months postoperatively
Quality of life assessment (joint awareness after surgery)
Time Frame: 2,6,12 months postoperatively
FJS-12, measures the clinical outcomes focusing on joint awareness after surgery
2,6,12 months postoperatively
Quality of life assessment (the condition of patients)
Time Frame: 2, 6, 12 months postoperatively
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
2, 6, 12 months postoperatively
Pain assessment
Time Frame: 2, 6, 12 months postoperatively
Visual Analog Score (VAS) for pain - dynamics pain assessment
2, 6, 12 months postoperatively
Quality of life assessment (an individual's activities of daily living)
Time Frame: 2, 6, 12 months postoperatively
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.
2, 6, 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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