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ACTIVE NOT RECRUITING
NCT04667390
NA

Total Knee Arthroplasty Using an Active Robotic System

Sponsor: I.M. Sechenov First Moscow State Medical University

View on ClinicalTrials.gov

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 using an active robotic surgical system. Traditional endoprosthetics of the knee joint (TKA) has now reached its maximum manufacturability and efficiency, but the accuracy of the performance depends on the skill and experience of the surgeon, as well as the efficiency of the cutting instrument (oscillator saw) when performing bone resection, the condition of the instrument and on the density of bone tissue fabric, which is highly variable. Modern RSS used in orthopedics include a robotic arm, robotic cutting devices with a computer navigation system, which are in active, semi-automatic or passive control mode. The main advantage of robotic systems is accurate preliminary planning using 3D modeling, use individual implant selection and virtual positioning.The active robotic surgical system TSolution-One allows participants to level the error in the positioning of the implant. The active robotic surgical system (ARSS) allows to correctly install the implant, which affects its service life, reduces the risks of postoperative complications, quickly returns to the usual way of life and forgets about the technical negative sensations and limitations that existed before the operation.It is planned to conduct an open-label retrospective and prospective clinical study in parallel observations.The study is planned to include 300 patients with osteoarthritis of the knee joint stage 3-4 (according to Kellgren-Lawrence). Investigators took three groups of patients, 100 patients each, and offered different options for total knee arthroplasty techniques.According to the research:-A clinical active robotic system for primary total knee arthroplasty will be introduced in Russia-There will be recommended indications and contraindications for this system in patients with gonarthrosis-The methodology of preoperative planning will be improved-The results of primary knee arthroplasty with an active robotic system will be evaluated in comparison with standard techniques and computer navigation-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.

Key Details

Gender

All

Age Range

45 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2018-09-01

Completion Date

2025-08

Last Updated

2024-05-02

Healthy Volunteers

No

Interventions

OTHER

total knee arthroplasty

total knee arthroplasty

Locations (1)

university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery

Moscow, Russia