Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07465484

Total Knee Arthroplasty in Varus Deformity

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery

Moscow, 119991, Russia

Location status: Recruiting

Location contact

Alexey Lychagin

CONTACT

[email protected]

89166389545

Konstantin Tomboidi

CONTACT

[email protected]

8-919-737-25-43

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Total knee arthroplasty using active robotic surgical system

Procedure

Total knee arthroplasty using active robotic surgical system

Primary outcomes

  1. 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. 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)

  3. 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)

Secondary outcomes

  1. 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. 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

  3. 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

  4. Pain assessment

    Time frame: 2, 6, 12 months postoperatively

    Visual Analog Score (VAS) for pain - dynamics pain assessment

  5. 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.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Acronym: TKA in varus

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Mar 12, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.