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Recruiting NCT05712291

Optimization of Total Knee Arthroplasty Using Robotic Systems

Conditions: Knee Osteoarthritis

Sex: All
Ages: 21 Years – 90 Years
Phase: NA
Enrollment: 250
Sponsor: I.M. Sechenov First Moscow State Medical University

Location: Russian Federation

Summary

For the first time, it is planned to create algorithms for working with a robotic system at different patient flow rates, optimize the use of computed tomography to assess bone density and pronounced osteophytes, develop an algorithm and tactics for treating bilateral osteoarthrosis of the knee joint using an active robotic system. Aim: optimization of total knee arthroplasty using robotic systems and improvement of treatment outcomes. Objectives: to develop algorithms for preoperative planning, surgical intervention using an active robotic system; to improve the technique of active robotic total knee arthroplasty in osteoporosis, osteosclerosis and pronounced osteophytes; to develop a tactic for the treatment of patients with bilateral osteoarthrosis of the knee joint using an active robotic system. It is planned to conduct an open-label retrospective and prospective clinical study in parallel observations.The study is planned to include 250 patients with osteoarthritis of the knee joint stage 3-4 (according to Kellgren-Lawrence). The methodology developed and improved in the dissertation will be introduced into the work of the clinical Departments of Traumatology, Orthopedics and Disaster Surgery, studying the learning curve.

Eligibility Criteria

Inclusion Criteria:Availability of written informed consent of the patient to participate in the study;Patients with stage 3-4 osteoarthritis of the knee joint (according to Kellgren-Lawrence).Men and women from 21 to 90 years old.Pain in the knee joint above 3 points according to VASOpportunity for observations during the entire study period (12 months);Mental adequacy, ability, willingness to cooperate and to fulfill the doctor's recommendations.Exclusion Criteria:Refusal of the patient from surgical treatment;Presence of contraindications to surgical treatment;Severe forms of diabetes mellitus (glycosylated hemoglobin> 9%);Diseases of the blood (thrombopenia, thrombocytopenia, anemia with Hb <90 g / l);The patient's unwillingness to conscious cooperation.Refusal of the patient to participate in the study;Non-compliance with the hospital regimen, according to the order of the Ministry of Health and Social Development of Russia dated 01.08.07, No. 514;The impossibility of observing the patient within the control period after the operation.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05712291). StuddyBuddy aggregates publicly available trial information.