Total Knee Arthroplasty Using an Active Robotic System

NCT04667390 | Active Not Recruiting DMC

• 1 other identifier: 199321
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 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

Knee Osteoarthritis

Keywords

total knee arthroplasty; the active robotic surgical system; robotic system in orthopedic

Outcome Measures

Primary Outcomes (3)

• Implant position assessment

  CT scanning; these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint ( LDFA, MPTA, MA, these diagnostic methods assess the position of the implant, analysis of deformation, assessment of the angles in the knee joint, analyze the rotation of implant).

  2 months after surgery

• Implant position assessment

  CT scanning

  6 months after surgery

• Implant position assessment

  CT scanning

  12 months after surgery

Other Outcomes (8)

• Quality of life and knee function assessment

  2,6,12 months after surgery

• Quality of life assessment ( joint awareness after surgery)

  2,6,12 months after surgery

• Spielberger test

  2,6,12 months after surgery

Study Arms (3)

total knee arthroplasty using the active robotic system

ACTIVE COMPARATOR

total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan

Other: total knee arthroplasty

total knee arthroplasty using computer navigation

ACTIVE COMPARATOR

Primary total knee arthroplasty using computer navigation and intraoperation control system

Other: total knee arthroplasty

total knee arthroplasty using the standard manual tekhnik

ACTIVE COMPARATOR

Primary total knee arthroplasty using the standard recommended set of instruments

Other: total knee arthroplasty

Interventions

total knee arthroplasty OTHER

total knee arthroplasty

total knee arthroplasty using computer navigation; total knee arthroplasty using the active robotic system; total knee arthroplasty using the standard manual tekhnik

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

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

Moscow, 119991, Russia

Location

Related Publications (2)

• LYCHAGIN A.V.1, a, GRITSYUK A.A.1, b, RUKIN Y.A.1, c, ELIZAROV M.P.1, d, THE HISTORY OF THE DEVELOPMENT OF ROBOTICS IN SURGERY AND ORTHOPEDICS (LITERATURE REVIEW). 2020; 1 (39)2020: 10.17238/issn2226-2016.2020.1.13-19

  BACKGROUND

• LYCHAGIN A.V. 1, a, RUKIN Y.A. 1, b, GRITSYUK A.A. 1, c, ELIZAROV M.P. 1, d, FIRST EXPERIENCE OF USING AN ACTIVE ROBOTIC SURGICAL SYSTEM IN TOTAL KNEE ARTHROPLASTY. 2019; 4 (38) 2019: 10.17238/issn2226-2016.2019.4.27-33

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Andrey Gritsyuk, PhD

  First MSMU( I.M.Sechenov).The Department of Traumatology,Orthopedics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: December 14, 2020
• Study Start: September 1, 2018
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

RU (1)