RecruitingNot Applicable

Total Knee Arthroplasty in Varus Deformity

Russia300 participantsStarted 2024-09-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✕

What they're measuring

Implant position assessment

Timeframe: 2 months postoperatively

Implant position assessment

Timeframe: 6 months postoperativley

Implant position assessment

Timeframe: 12 months postoperatively

Trial details

NCT IDNCT07465484

SponsorI.M. Sechenov First Moscow State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

View on ClinicalTrials.gov More Knee Osteoarthritis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
✕