Personalized Approach to Robotic Total Knee Arthroplasty

NCT ID: NCT05750784

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-08-31

Brief Summary

For the first time in Russia, it is planned to introduce a system of personalized preoperative planning, applying the concept of kinematic alignment in robotic knee arthroplasty. Aim: to improve the results of robotic knee alignment by developing and implementing a personalized approach in preoperative planning. Objectives: to develop a system of personalized robotic knee arthroplasty; implementation of the system in clinical practice, to determine indications, contraindications; study of the results of personalized endoprosthetics, comparison with the results of mechanical alignment; detection of complications; development of an algorithm and protocol for personalized endoprosthetics. It is planned to conduct an open retrospective and prospective clinical study in parallel groups. The study is planned to include 150 patients with osteoarthritis of the knee joint stage 3-4 (according to Kellgren-Lawrence). 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.

Detailed Description

Relevance: Currently, there are 2 main concepts of total knee arthroplasty: mechanical and kinematic alignment of the axis of the lower limb. Mechanical alignment was first proposed by Install JN. It implied the standardization of equipment and tools, the reconstruction of the mechanically neutral axis of the limb. However, the number of patients dissatisfied with the result of endoprosthetics remained high. Bellemans' work argues that for many patients, a mechanically neutral axis of the lower limb is not the normal. This is how the concept of kinematic alignment appeared, the main idea of which was to create an absolutely balanced joint throughout the entire volume of movements and recreate the true levels of articular lines of the joint, before the onset of osteoarthritis. However, the use of standard tools and manual techniques does not allow the full use of this concept. Robotic surgery has the main advantage over manual techniques in the high accuracy of implant positioning and allows you to calculate the mechanical axis and the level of the articular line with high accuracy at the stage of preoperative preparation. The introduction of personalized programs, implants in knee arthroplasty, together with the use of active robotic technology, can restore the individual anatomy and function of the lower limb, which will improve the results of endoprosthetics and reduce the percentage of patients dissatisfied with the operation.

The novelty of the proposed topic: For the first time in Russia, it is planned to introduce a system of personalized preoperative planning, applying the concept of kinematic alignment in robotic knee arthroplasty.

Aim and objectives of the research:

Aim: To improve the results of robotic knee alignment by developing and implementing a personalized approach in preoperative planning.

Objectives: to develop a system of personalized robotic knee arthroplasty; implementation of the system in clinical practice, to determine indications, contraindications; study of the results of personalized endoprosthetics, comparison with the results of mechanical alignment; detection of complications; development of an algorithm and protocol for personalized endoprosthetics.

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 150 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: HKA, LDFA, MPTA, Q; Preoperative 3D planning on the TPLAN workstation; Surgical treatment. 1) Primary total knee arthroplasty using the active robotic surgical system TSolution One, TCAT, using the concept of kinematic alignment; 2) Primary total knee arthroplasty using the active robotic surgical system TSolution One, TCAT, using the concept of mechanical alignment.

Evaluation of patient treatment results according to scales: VAS, KSS, OKS, WOMAC, ASA, FJS-12.

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:

For the first time in Russia, an active robotic system will be introduced into clinical practice using the concept of personalized endoprosthetics for primary total knee .

Indications for the use of this algorithm in patients with osteoarthritis of the knee joint will be determined.

The methodology of preoperative planning will be improved. The results of the initial personalized total knee replacement with the use of an active robotic system will be evaluated.

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

total knee arthroplasty using the active robotic system using the kinematic alignment concept

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

Group Type: OTHER

Total knee arthroplasty using the active robotic surgical system

Intervention Type: PROCEDURE

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

total knee arthroplasty using the active robotic system using the mechanical alignment concept

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

Group Type: OTHER

Total knee arthroplasty using the active robotic surgical system

Intervention Type: PROCEDURE

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

Interventions

Total knee arthroplasty using the active robotic surgical system

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

Intervention Type: PROCEDURE

Eligibility Criteria

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 21 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Moscow, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Alexey Lychagin

Role: CONTACT

clinic@travma.moscow

89166389545

Andrey Gritsyuk

Role: CONTACT

andrewgritsru@gmail.com

89998372360

Facility Contacts

Andrey Gritsyuk

Role: primary

andewgritsru@gmail.com

89998372360

References

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

Reference Type: 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

Reference Type: BACKGROUND

Other Identifiers

199731

Identifier Type: -

Identifier Source: org_study_id