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Total Knee Arthroplasty Using an Active Robotic System

NCT04667390 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-05-02

No results posted yet for this study

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.

Conditions

Interventions

OTHER

total knee arthroplasty

total knee arthroplasty

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Andrey Gritsyuk, PhD · First MSMU( I.M.Sechenov).The Department of Traumatology,Orthopedics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667390 on ClinicalTrials.gov