Total Knee Arthroplasty in Varus Deformity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Total knee arthroplasty using active robotic surgical system
Procedure/SurgeryTotal knee arthroplasty using active robotic surgical system
Total knee arthroplasty using active robotic surgical system
Procedure/SurgeryTotal knee arthroplasty using active robotic surgical system
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Total Knee Arthroplasty using the active robotic system using the kinematic alignment conceptActive comparator 1 intervention
Group B: Total Knee Arthroplasty using the active robotic system using the mechanical alignment conceptActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
2 months postoperatively2
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)
Time frame
6 months postoperativley3
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)
Time frame
12 months postoperativelySecondary outcomes
1
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)
Time frame
2,6,12 months postoperatively2
Quality of life assessment (joint awareness after surgery)
FJS-12, measures the clinical outcomes focusing on joint awareness after surgery
Time frame
2,6,12 months postoperatively3
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
Time frame
2, 6, 12 months postoperatively4
Pain assessment
Visual Analog Score (VAS) for pain - dynamics pain assessment
Time frame
2, 6, 12 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov