Knee OsteoarthritisNCT05750784
Personalized Approach to Robotic Total Knee Arthroplasty
A study testing Total knee arthroplasty using the active robotic surgical system 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 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. 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 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
Andrey Gritsyuk, 89998372360, andewgritsru@gmail.com
About this study
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.
Read the 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:
- 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, 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
- Being tested
- Total knee arthroplasty using the active robotic surgical system
- Keywords
- total knee arthroplasty, robotic total knee arthroplasty, the active robotic surgical system, kinematic alignment, mechanical alignment
- 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
| Study group | Role | What they receive |
|---|---|---|
| total knee arthroplasty using the active robotic system using the kinematic alignment concept | 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 |
| total knee arthroplasty using the active robotic system using the mechanical alignment concept | 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 |
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 posted2 Mar 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750784
- Sponsor's protocol ID
- 199731
- Status last verified
- Sep 2022
- First submitted
- 20 Feb 2023
- Last updated
- 2 Mar 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Approach to Robotic Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05750784
- Acronym / sponsor ID
- 199731
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, robotic total knee arthroplasty, the active robotic surgical system, kinematic alignment, mechanical alignment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 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
- 2 Mar 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 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:
- 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, 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.
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 using the kinematic alignment concept | Other | Procedure: 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 |
| total knee arthroplasty using the active robotic system using the mechanical alignment concept | Other | Procedure: 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 |
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 using the kinematic alignment concept, total knee arthroplasty using the active robotic system using the mechanical alignment concept |
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 2 Mar 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.
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 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 2 Mar 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 (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 NCT05750784, 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 2 Mar 2023.