Knee Osteoarthritis, Knee Osteoarthritis in Varus
Conditions
Keywords
Kinematic and Mechanical alignment, Weight-bearing CT
Brief 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). 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
PROCEDURETotal knee arthroplasty using active robotic surgical system
Total knee arthroplasty using active robotic surgical system
Sponsors
I.M. Sechenov First Moscow State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant position assessment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life and knee function assessment | 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) |
| Quality of life assessment (joint awareness after surgery) | 2,6,12 months postoperatively | FJS-12, measures the clinical outcomes focusing on joint awareness after surgery |
| Quality of life assessment (the condition of patients) | 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 |
| Pain assessment | 2, 6, 12 months postoperatively | Visual Analog Score (VAS) for pain - dynamics pain assessment |
| Quality of life assessment (an individual's activities of daily living) | 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. |
Countries
Russia
Outcome results
None listed