Knee OsteoarthritisNCT05712291
Optimization of Total Knee Arthroplasty Using Robotic Systems
A study testing Total knee arthroplasty using the active robotic surgical system, TSolution One TCAT, and system for planning TPlan and total knee arthroplasty using the standard manual technic in people with Knee Osteoarthritis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total knee arthroplasty using the active robotic surgical system, TSolution One TCAT, and system for planning TPlan and total knee arthroplasty using the standard manual technic
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Moscow, 119991
Maxim Gavlovsky, 89100132671, gavlovsky.m@yandex.ru
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- 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
- Keywords
- total knee arthroplasty, robotic total knee arthroplasty, the active robotic surgical system, robotic system in orthopedic
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty using the active robotic surgical systemProcedure or surgery
Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan
TSolution One TCAT, and system for planning TPlanDevice
the active robotic surgical system TSolution One TCAT, and system for planning TPlan
total knee arthroplasty using the standard manual technicProcedure or surgery
total knee arthroplasty using the standard manual technic
| Study group | Role | What they receive |
|---|---|---|
| total knee arthroplasty using the active robotic system | Other | Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan Receives: Procedure: Total knee arthroplasty using the active robotic surgical system; Device: TSolution One TCAT, and system for planning TPlan |
| total knee arthroplasty using the standard manual technic | Other | Primary total knee arthroplasty using the standard recommended set of instruments Receives: Procedure: total knee arthroplasty using the standard manual technic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months after surgery
Implant position assessment
CT scanning
Measured: 6 months after surgery
Implant position assessment
CT scanning
Measured: 12 months after surgery
Secondary outcomes (5)
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)
Measured: 2,6,12 months after surgery
Quality of life assessment (joint awareness after surgery)
FJS-12, measures the clinical outcomes focusing on joint awareness after surgery
Measured: 2,6,12 months 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
Measured: 2,6,12 months after surgery
Pain assessment
Visual Analog Score (VAS) for pain - dynamics pain assessment
Measured: 2,6,12 months after surgery
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.
Measured: 2,6,12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Sep 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey Gritsyuk, PhD, Study chair, The First MSMU (I.M.Sechenov).The Department of Traumatology, Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712291
- Sponsor's protocol ID
- 199617
- Status last verified
- Sep 2022
- First submitted
- 26 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Total Knee Arthroplasty Using Robotic Systems
- ClinicalTrials.gov ID
- NCT05712291
- Acronym / sponsor ID
- 199617
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, robotic total knee arthroplasty, the active robotic surgical system, robotic system in orthopedic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total knee arthroplasty using the active robotic system | Other | Procedure: Total knee arthroplasty using the active robotic surgical system, Device: TSolution One TCAT, and system for planning TPlanTotal knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan |
| total knee arthroplasty using the standard manual technic | Other | Procedure: total knee arthroplasty using the standard manual technicPrimary total knee arthroplasty using the standard recommended set of instruments |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplasty using the active robotic surgical systemTotal knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan | Procedure or surgery | total knee arthroplasty using the active robotic system |
| TSolution One TCAT, and system for planning TPlanthe active robotic surgical system TSolution One TCAT, and system for planning TPlan | Device | total knee arthroplasty using the active robotic system |
| total knee arthroplasty using the standard manual technictotal knee arthroplasty using the standard manual technic | Procedure or surgery | total knee arthroplasty using the standard manual technic |
Primary outcome
Implant position assessment
Time frame: 2 months after surgery
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
Time frame: 6 months after surgery
CT scanning
Implant position assessment
Time frame: 12 months after surgery
CT scanning
5 secondary outcomes
Quality of life and knee function assessment
Time frame: 2,6,12 months after surgery
Quality of life assessment (joint awareness after surgery)
Time frame: 2,6,12 months after surgery
Quality of life assessment (the condition of patients)
Time frame: 2,6,12 months after surgery
Pain assessment
Time frame: 2,6,12 months after surgery
Quality of life assessment (an individual's activities of daily living)
Time frame: 2,6,12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- BackgroundLYCHAGIN 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
- BackgroundLYCHAGIN 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey Gritsyuk, PhD study chair
The First MSMU (I.M.Sechenov).The Department of Traumatology, Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty using the active robotic surgical system, TSolution One TCAT, and system for planning TPlan and total knee arthroplasty using the standard manual technic in people with Knee Osteoarthritis, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexey Lychagin, PhD (89166389545, clinic@travma.moscow), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant position assessment (time frame: 2 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05712291, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.