NCT07465484 Total Knee Arthroplasty in Varus Deformity
| NCT ID | NCT07465484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.M. Sechenov First Moscow State Medical University |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-09-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07465484 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07465484 currently recruiting?
Yes, NCT07465484 is actively recruiting participants. Visit ClinicalTrials.gov or contact I.M. Sechenov First Moscow State Medical University to inquire about joining.
Where is the NCT07465484 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07465484 clinical trial?
NCT07465484 is sponsored by I.M. Sechenov First Moscow State Medical University. The trial plans to enroll 300 participants.