Total Knee Arthroplasty Using an Active Robotic System

Knee Osteoarthritis Clinical Trial

Official title:

Total Knee Arthroplasty Using an Active Robotic System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04667390
• Other study ID #: 199321
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Manipulation Arm (PUMA) 560 was introduced to perform CT-guided brain biopsy. In 1992, the Robodoc system (IBM) became the first orthopedic robotic system used in orthopedics for hip replacement, which subsequently improved the ability to automatically perform the stages of prosthetics. (Caspar system, Acrobot). Around the same time, the development of a robot for performing total knee arthroplasty began.

A distinctive feature of total knee arthroplasty (TKA) is the manufacturability of the stages and the high accuracy of surgical manipulations, which attracts the attention of many robotic surgical systems (RSS).

Traditional total knee arthroplasty (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 accuracy of the cutting instrument (oscillator saw) when performing bone resection, the condition of the instrument and the density of the bone fabric, which is highly variable. The use of intramedullary guides during conventional surgery increases the risk of thromboembolic and cardiorespiratory complications. Computer navigation partially solves the problem of resection accuracy, infrared cameras read information from sensors and display a model with anatomical and kinematic features of the knee joint, which helps the surgeon to more accurately determine the level and direction of resection, but cannot ensure the accuracy of this manipulation and compliance with the preoperative plan.

Modern RSS used in orthopedics include a robotic arm, robotic cutting devices with a computer navigation system that operate in an active, semi-automatic, or passive control mode. The main advantage of robotic systems is accurate preoperative planning using 3D modeling, the possibility of individual selection of the implant and virtual positioning. Another advantage is the ability to accurately reproduce the preoperative plan during orthopedic surgery.

Today, active robotic surgical systems (ARSS) are used in clinical practice. ROBODOC / TSolution One. Robotic Surgical System (Curexo Technology, Fremont, Calif.), And Navio PFS (Blue Belt Technologies, Plymouth, Minnesota) Semi-Active Surgical Systems, OMNI Robotic System (OMNIlife Science, East Taunton, MA), RIO Robotic Arm Interactive Orthopedic System (Mako Surgical Corporation, Fort Lauderdale, Florida), ROSA Knee (Zimmer Zimmer Biomet, Montreal (Quebec), Canada).

The active robotic surgical system TSolution-One allows participants to level the error in the positioning of the implant. The accuracy of the filing is not affected by the manual skills of the surgeon, and does not depend on the density of bone tissue. Significant advantages of the system are: 1) precise preoperative breading; 2) rigid fixation of the limb, hip and tibia displacement sensors; 3) active autonomous milling without the participation of a surgeon; 4) accuracy of resection according to the preoperative plan; 5) rotation of the tibial component as in the preoperative plan; 6) no manual tools required; 7) postoperative control of the results of the operation. The active robotic surgical system (ARSS) allows participants to correctly install the implant, which affects its service life, reduces the risks of postoperative complications, the patient quickly returns to his usual way of life and forgets about those negative feelings and limitations that were before the operation.

The novelty of the proposed topic: For the first time in Russia, it is planned to introduce and study total knee arthroplasty using an active robotic system. Apply the use of a 3D patient model and the creation of an individual personalized preoperative plan using a robotic system for knee arthroplasty.

Aim and objectives of the research:

aim: To increase the efficiency of primary total knee arthroplasty using an active robotic surgical system.

objectives:

1. To study the possibilities of an active robotic system for primary arthroplasty of the knee joint, to determine indications and contraindications for use in endoprosthetics of the knee joint in patients with primary arthrosis.

2. To evaluate the technique of preoperative planning for total knee arthroplasty using an active robotic system in patients with arthrosis.

3. To work out the technique of total knee arthroplasty using an active robotic system, compare with computer navigation and the traditional method.

4. To evaluate the results of total knee arthroplasty using an active robotic system in comparison with the use of standard techniques and computer navigation.

5. Examine complications

6. Determine the place of the active robotic surgical unit in the total knee arthroplasty system.

Type of new research: an open-label, retrospective and prospective observational clinical study in parallel groups.

Research object and number of observations: the study is planned to include 300 patients with osteoarthritis of the knee joint of stage 3-4 (according to Kellgren-Lawrence).

Methods of the research:

1. General clinical examination of patients (collection of complaints, examination, assessment of physical findings and local status);

2. Assessment of the range of motion in the knee joint before and after surgery;

3. Performing X-ray images and CT of the knee joint before and after surgery, with the determination of the angles: LDFA, MPTA, Q, MAD;

4. Preoperative 3D planning on the TPLAN workstation;

5. Surgical treatment. 1) Primary total knee arthroplasty using the active robotic surgical system TSolution One, TCAT 2) Primary total knee arthroplasty using computer navigation 3) Primary total knee arthroplasty using the standard recommended set of instruments.

6. Evaluation of patient treatment results according to scales: VAS, KSS, OKS, WOMAC, SF-36, ASA, FJS-12, Spielberger test.

7. Methods of statistical processing of the material: statistical processing of data is planned to be carried out on a personal computer using Excel software packages and using standard methods of variation statistics using SPSS 16 statistical software packages.

Estimated research result:

1. For the first time in Russia, an active robotic system for primary total knee arthroplasty will be introduced into clinical practice.

2. Indications and contraindications for the use of this system in patients with gonarthrosis will be determined.

3. The methodology of preoperative planning will be improved.

4. The results of primary total knee arthroplasty using an active robotic system will be evaluated in comparison with the use of standard techniques and computer navigation.

5. The methodology developed and improved in the dissertation will be introduced into the work of the clinical bases of the Department of Traumatology, Orthopedics and Disaster Surgery, the study of the learning curve.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Availability of written informed consent of the patient to participate in the study;

2. Patients with stage 3-4 osteoarthritis of the knee joint (according to Kellgren-Lawrence.).

3. Men and women from 45 to 90 years old.

4. Pain in the knee joint above 3 points according to VAS

5. Opportunity for observations during the entire study period (12 months);

6. Mental adequacy, ability, willingness to cooperate and to fulfill the doctor's recommendations.

Exclusion Criteria:

1. Refusal of the patient from surgical treatment;

2. Presence of contraindications to surgical treatment;

3. Severe forms of diabetes mellitus (glycosylated hemoglobin> 9%);

4. Diseases of the blood (thrombopenia, thrombocytopenia, anemia with Hb <90 g / l);

5. The patient's unwillingness to conscious cooperation.

6. Refusal of the patient to participate in the study;

7. 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;

8. The impossibility of observing the patient within the control period after the operation.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• total knee arthroplasty
total knee arthroplasty

Locations

Country	Name	City	State
Russian Federation	university clinical hospital ? 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life and knee function assessment	Knee Society Score(KSS score), which combines subjective and objective information and separates the knee score (pain, stability, range of motion etc.) from the functional score of the patient (ability to walk, go up and down stairs).	2,6,12 months after surgery
Other	Quality of life assessment ( joint awareness after surgery)	FJS-12, measures the clinical outcomes focusing on joint awareness after surgery	2,6,12 months after surgery
Other	Spielberger test	Given these characteristics, test anxiety can be viewed as a situation-specific personality trait	2,6,12 months after surgery
Other	Overall health score assessment	ASA score	2,6,12 months after surgery
Other	Quality of life assessment (mental, physical assessment)	SF-36 score The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).	2,6,12 months after surgery
Other	Quality of life assessment (the condition of patients)	WOMAC score is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints	2,6,12 months after surgery
Other	Pain assessment	Visual Analog Score for pain (VAS)-dynamics pain assessment	2,6,12 months after surgery
Other	Quality of life assessment (an individual's activities of daily living )	OKS score The OKS is a patient reported outcome measure that consists of 12 questions about an individual's activities of daily living and how they have been affected by pain over the preceding four weeks.	2,6,12 months after surgery
Primary	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
Primary	Implant position assessment	CT scanning	6 months after surgery
Primary	Implant position assessment	CT scanning	12 months after surgery