Clinical trial NCT05712291: Optimization of Total Knee Arthroplasty Using Robotic Systems
Official title: Optimization of Total Knee Arthroplasty Using Robotic Systems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: total knee arthroplasty
robotic total knee arthroplasty
the active robotic surgical system
robotic system in orthopedic
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For the first time, it is planned to create algorithms for working with a robotic system at different patient flow rates, optimize the use of computed tomography to assess bone density and pronounced osteophytes, develop an algorithm and tactics for treating bilateral osteoarthrosis of the knee joint using an active robotic system. Aim: optimization of total knee arthroplasty using robotic systems and improvement of treatment outcomes. Objectives: to develop algorithms for preoperative planning, surgical intervention using an active robotic system; to improve the technique of active robotic total knee arthroplasty in osteoporosis, osteosclerosis and pronounced osteophytes; to develop a tactic for the treatment of patients with bilateral osteoarthrosis of the knee joint using an active robotic system. It is planned to conduct an open-label retrospective and prospective clinical study in parallel observations.The study is planned to include 250 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: Robotic orthopedic surgery has been around for over twenty years and is becoming more relevant every day. Modern systems consist of a robotic arm, robotic cutting tools and robotic milling systems with a variety of navigation systems with using active, semi-automatic or passive control systems. In the analysis of clinical studies, it can be concluded that these robotic systems reduce variability and increase the accuracy of positioning and alignment of prosthesis components. A new generation of robotic systems is currently being actively introduced into the field of arthroplasty interventions, which can eliminate pain and improve the quality of life of patients with end-stage osteoarthritis of the knee joint.

Total knee arthroplasty (TKA) in the terminal stages of gonarthrosis is one of the most effective and technologically advanced operations. More than 700,000 surgeries are performed annually in the United States and the number continues to grow. According to the literature in Russia for 2011-2019. out of 27,906 TKAs, the proportion of primary arthroplasties was 92.3% (n = 25,759). It should be noted that the number of operations of primary knee arthroplasty increased almost 2 times - from 1678 in 2011 up to 3,730 in 2019. Therefore, TKA is attracting attention from many manufacturers of robotic surgical systems.

With the introduction of an active robotic system into clinical practice, a number of problems have arisen: high time costs of perioperative actions; the operation of an active robotic unit with high or low bone density, pronounced osteophytes; operation of an active robotic unit in bilateral TKA.

The novelty of the proposed topic: For the first time in Russia it is planned to create algorithms for working with a robotic system at different patient flow rates, optimize the use of computed tomography to assess bone density and pronounced osteophytes, develop an algorithm and tactics for treating bilateral osteoarthrosis of the knee joint using an active robotic system.

Aim and objectives of the research:

Aim: optimization of total knee arthroplasty using robotic systems and improvement of treatment outcomes.

Objectives: to develop algorithms for preoperative planning, surgical intervention using an active robotic system; to improve the technique of active robotic total knee arthroplasty in osteoporosis, osteosclerosis and pronounced osteophytes; to develop a tactic for the treatment of patients with bilateral osteoarthrosis of the knee joint using an active robotic 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 250 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.

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:

Algorithms of actions for preoperative planning and surgical intervention will be developed.

An approach will be developed for the diagnosis, classification and treatment of patients with pronounced areas of osteosclerosis of the knee joint during robotic total knee arthroplasty.

An approach will be developed for the diagnosis and treatment of patients with concomitant osteoporosis in robotic total knee arthroplasty.

A tactic for the treatment of patients with bilateral osteoarthritis of the knee joint of stage 3-4 (according to Kellgren-Lawrence) will be proposed.

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.

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.

Primary outcomes:
measure: Implant position assessment
timeFrame: 2 months after surgery
measure: Implant position assessment
timeFrame: 6 months after surgery
measure: Implant position assessment
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Quality of life and knee function assessment
timeFrame: 2,6,12 months after surgery
measure: Quality of life assessment (joint awareness after surgery)
timeFrame: 2,6,12 months after surgery
measure: Quality of life assessment (the condition of patients)
timeFrame: 2,6,12 months after surgery
measure: Pain assessment
timeFrame: 2,6,12 months after surgery
measure: Quality of life assessment (an individual's activities of daily living)
timeFrame: 2,6,12 months after surgery
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Study officials:
affiliation: The First MSMU (I.M.Sechenov).The Department of Traumatology, Orthopedics
name: Andrey Gritsyuk, PhD
role: STUDY_CHAIR
References:
citation: 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
citation: 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