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Optimization of Total Knee Arthroplasty Using Robotic Systems

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Total knee arthroplasty using the active robotic surgical system
TSolution One TCAT, and system for planning TPlan
total knee arthroplasty using the standard manual technic
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring total knee arthroplasty, robotic total knee arthroplasty, the active robotic surgical system, robotic system in orthopedic

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 21 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. Exclusion Criteria: 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

total knee arthroplasty using the active robotic system

total knee arthroplasty using the standard manual technic

Arm Description

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

Primary total knee arthroplasty using the standard recommended set of instruments

Outcomes

Primary Outcome Measures

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)
Implant position assessment
CT scanning
Implant position assessment
CT scanning

Secondary Outcome Measures

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)
Quality of life assessment (joint awareness after surgery)
FJS-12, measures the clinical outcomes focusing on joint awareness after surgery
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
Pain assessment
Visual Analog Score (VAS) for pain - dynamics pain assessment
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.

Full Information

First Posted
January 26, 2023
Last Updated
February 20, 2023
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05712291
Brief Title
Optimization of Total Knee Arthroplasty Using Robotic Systems
Official Title
Optimization of Total Knee Arthroplasty Using Robotic Systems
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: General clinical examination of patients (collection of complaints, examination, assessment of physical findings and local status); Assessment of the range of motion in the knee joint before and after surgery; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
total knee arthroplasty, robotic total knee arthroplasty, the active robotic surgical system, robotic system in orthopedic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
total knee arthroplasty using the active robotic system
Arm Type
Other
Arm Description
Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan
Arm Title
total knee arthroplasty using the standard manual technic
Arm Type
Other
Arm Description
Primary total knee arthroplasty using the standard recommended set of instruments
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty using the active robotic surgical system
Intervention Description
Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan
Intervention Type
Device
Intervention Name(s)
TSolution One TCAT, and system for planning TPlan
Intervention Description
the active robotic surgical system TSolution One TCAT, and system for planning TPlan
Intervention Type
Procedure
Intervention Name(s)
total knee arthroplasty using the standard manual technic
Intervention Description
total knee arthroplasty using the standard manual technic
Primary Outcome Measure Information:
Title
Implant position assessment
Description
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)
Time Frame
2 months after surgery
Title
Implant position assessment
Description
CT scanning
Time Frame
6 months after surgery
Title
Implant position assessment
Description
CT scanning
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Quality of life and knee function assessment
Description
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)
Time Frame
2,6,12 months after surgery
Title
Quality of life assessment (joint awareness after surgery)
Description
FJS-12, measures the clinical outcomes focusing on joint awareness after surgery
Time Frame
2,6,12 months after surgery
Title
Quality of life assessment (the condition of patients)
Description
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
Time Frame
2,6,12 months after surgery
Title
Pain assessment
Description
Visual Analog Score (VAS) for pain - dynamics pain assessment
Time Frame
2,6,12 months after surgery
Title
Quality of life assessment (an individual's activities of daily living)
Description
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.
Time Frame
2,6,12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 21 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexey Lychagin, PhD
Phone
89166389545
Email
clinic@travma.moscow
First Name & Middle Initial & Last Name or Official Title & Degree
Maxim Gavlovsky
Phone
89100132671
Email
gavlovsky.m@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrey Gritsyuk, PhD
Organizational Affiliation
The First MSMU (I.M.Sechenov).The Department of Traumatology, Orthopedics
Official's Role
Study Chair
Facility Information:
Facility Name
University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxim Gavlovsky
Phone
89100132671
Email
gavlovsky.m@yandex.ru

12. IPD Sharing Statement

Citations:
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
Results Reference
background
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
Results Reference
background
Links:
URL
https://eng.jkto.ru/journal-issues-pdf/
Description
DEPARTMENT OF TRAUMATOLOGY AND ORTHOPEDICS
URL
https://eng.jkto.ru/journal-issues-pdf/39_jkto_ru_2020_1_v1_1.pdf
Description
THE HISTORY OF THE DEVELOPMENT OF ROBOTICS IN SURGERY AND ORTHOPEDICS (LITERATURE REVIEW)
URL
https://eng.jkto.ru/journal-issues-pdf/38_jkto_ru_2019_4veb.pdf
Description
FIRST EXPERIENCE OF USING AN ACTIVE ROBOTIC SURGICAL SYSTEM IN TOTAL KNEE ARTHROPLASTY

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Optimization of Total Knee Arthroplasty Using Robotic Systems

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