Status:
ACTIVE_NOT_RECRUITING
Total Knee Arthroplasty Using an Active Robotic System
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
45-90 years
Phase:
NA
Brief Summary
For the first time in Russia, it is planned to introduce and study primary knee arthroplasty using an active robotic system. The aim is to increase the efficiency of primary total knee arthroplasty us...
Detailed Description
Relevance: Robotic technologies were first introduced into medicine in the 1950s. The use of robotic systems in surgery begins with the use in neurosurgery. In 1985, the Programmable Universal Manipul...
Eligibility Criteria
Inclusion
- 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 45 to 90 years old.
- Pain in the knee joint above 3 points according to VAS
- Opportunity for observations during the entire study period (12 months);
- Mental adequacy, ability, willingness to cooperate and to fulfill the doctor's recommendations.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04667390
Start Date
September 1 2018
End Date
August 1 2025
Last Update
May 2 2024
Active Locations (1)
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1
university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Moscow, Russia, 119991