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Recruiting NCT07465484

Total Knee Arthroplasty in Varus Deformity

No phase Interventional Knee Osteoarthritis Knee Osteoarthritis in Varus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total knee arthroplasty using active robotic surgical system, Total knee arthroplasty using active robotic surgical system.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Knee Osteoarthritis in Varus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure Total knee arthroplasty using active robotic surgical system
    Total knee arthroplasty using active robotic surgical system
  • Procedure Total knee arthroplasty using active robotic surgical system
    Total knee arthroplasty using active robotic surgical system

Primary outcome measures

  • Implant position assessment [Time frame: 2 months postoperatively]
  • Implant position assessment [Time frame: 6 months postoperativley]
  • Implant position assessment [Time frame: 12 months postoperatively]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Russia · 1 center
  • University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The De — Moscow

Identifiers

NCT: NCT07465484 · 199819

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗