Knee OsteoarthritisNCT04667390
Total Knee Arthroplasty Using an Active Robotic System
A study testing total knee arthroplasty 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 and study primary knee arthroplasty using an active robotic system. The aim is to increase the efficiency of primary total knee arthroplasty using an active robotic surgical system. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- total knee arthroplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2018to 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 45 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 45 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
university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Moscow, 119991
About this study
For the first time in Russia, it is planned to introduce and study primary knee arthroplasty using an active robotic system. The aim is to increase the efficiency of primary total knee arthroplasty using an active robotic surgical system. Traditional endoprosthetics of the knee joint (TKA) has now reached its maximum manufacturability and efficiency, but the accuracy of the performance depends on the skill and experience of the surgeon, as well as the efficiency of the cutting instrument (oscillator saw) when performing bone resection, the condition of the instrument and on the density of bone tissue fabric, which is highly variable. Modern RSS used in orthopedics include a robotic arm, robotic cutting devices with a computer navigation system, which are in active, semi-automatic or passive control mode. The main advantage of robotic systems is accurate preliminary planning using 3D modeling, use individual implant selection and virtual positioning.The active robotic surgical system TSolution-One allows participants to level the error in the positioning of the implant. The active robotic surgical system (ARSS) allows to correctly install the implant, which affects its service life, reduces the risks of postoperative complications, quickly returns to the usual way of life and forgets about the technical negative sensations and limitations that existed before the operation.It is planned to conduct an open-label retrospective and prospective clinical study in parallel observations.The study is planned to include 300 patients with osteoarthritis of the knee joint stage 3-4 (according to Kellgren-Lawrence). Investigators took three groups of patients, 100 patients each, and offered different options for total knee arthroplasty techniques.According to the research:-A clinical active robotic system for primary total knee arthroplasty will be introduced in Russia-There will be recommended indications and contraindications for this system in patients with gonarthrosis-The methodology of preoperative planning will be improved-The results of primary knee arthroplasty with an active robotic system will be evaluated in comparison with standard techniques and computer navigation-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 technologies were first introduced into medicine in the 1950s. The use of robotic systems in surgery begins with the use in neurosurgery. In 1985, the Programmable Universal Manipulation Arm (PUMA) 560 was introduced to perform CT-guided brain biopsy. In 1992, the Robodoc system (IBM) became the first orthopedic robotic system used in orthopedics for hip replacement, which subsequently improved the ability to automatically perform the stages of prosthetics. (Caspar system, Acrobot). Around the same time, the development of a robot for performing total knee arthroplasty began.
A distinctive feature of total knee arthroplasty (TKA) is the manufacturability of the stages and the high accuracy of surgical manipulations, which attracts the attention of many robotic surgical systems (RSS).
Traditional total knee arthroplasty (TKA) has now reached its maximum manufacturability and efficiency, but the accuracy of the performance depends on the skill and experience of the surgeon, as well as the accuracy of the cutting instrument (oscillator saw) when performing bone resection, the condition of the instrument and the density of the bone fabric, which is highly variable. The use of intramedullary guides during conventional surgery increases the risk of thromboembolic and cardiorespiratory complications. Computer navigation partially solves the problem of resection accuracy, infrared cameras read information from sensors and display a model with anatomical and kinematic features of the knee joint, which helps the surgeon to more accurately determine the level and direction of resection, but cannot ensure the accuracy of this manipulation and compliance with the preoperative plan.
Modern RSS used in orthopedics include a robotic arm, robotic cutting devices with a computer navigation system that operate in an active, semi-automatic, or passive control mode. The main advantage of robotic systems is accurate preoperative planning using 3D modeling, the possibility of individual selection of the implant and virtual positioning. Another advantage is the ability to accurately reproduce the preoperative plan during orthopedic surgery.
Today, active robotic surgical systems (ARSS) are used in clinical practice. ROBODOC / TSolution One. Robotic Surgical System (Curexo Technology, Fremont, Calif.), And Navio PFS (Blue Belt Technologies, Plymouth, Minnesota) Semi-Active Surgical Systems, OMNI Robotic System (OMNIlife Science, East Taunton, MA), RIO Robotic Arm Interactive Orthopedic System (Mako Surgical Corporation, Fort Lauderdale, Florida), ROSA Knee (Zimmer Zimmer Biomet, Montreal (Quebec), Canada).
The active robotic surgical system TSolution-One allows participants to level the error in the positioning of the implant. The accuracy of the filing is not affected by the manual skills of the surgeon, and does not depend on the density of bone tissue. Significant advantages of the system are: 1) precise preoperative breading; 2) rigid fixation of the limb, hip and tibia displacement sensors; 3) active autonomous milling without the participation of a surgeon; 4) accuracy of resection according to the preoperative plan; 5) rotation of the tibial component as in the preoperative plan; 6) no manual tools required; 7) postoperative control of the results of the operation. The active robotic surgical system (ARSS) allows participants to correctly install the implant, which affects its service life, reduces the risks of postoperative complications, the patient quickly returns to his usual way of life and forgets about those negative feelings and limitations that were before the operation.
The novelty of the proposed topic: For the first time in Russia, it is planned to introduce and study total knee arthroplasty using an active robotic system. Apply the use of a 3D patient model and the creation of an individual personalized preoperative plan using a robotic system for knee arthroplasty.
Aim and objectives of the research:
aim: To increase the efficiency of primary total knee arthroplasty using an active robotic surgical system.
objectives:
- To study the possibilities of an active robotic system for primary arthroplasty of the knee joint, to determine indications and contraindications for use in endoprosthetics of the knee joint in patients with primary arthrosis.
- To evaluate the technique of preoperative planning for total knee arthroplasty using an active robotic system in patients with arthrosis.
- To work out the technique of total knee arthroplasty using an active robotic system, compare with computer navigation and the traditional method.
- To evaluate the results of total knee arthroplasty using an active robotic system in comparison with the use of standard techniques and computer navigation.
- Examine complications
- Determine the place of the active robotic surgical unit in the total knee arthroplasty 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 300 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: LDFA, MPTA, Q, MAD;
- Preoperative 3D planning on the TPLAN workstation;
- Surgical treatment. 1) Primary total knee arthroplasty using the active robotic surgical system TSolution One, TCAT 2) Primary total knee arthroplasty using computer navigation 3) Primary total knee arthroplasty using the standard recommended set of instruments.
- Evaluation of patient treatment results according to scales: VAS, KSS, OKS, WOMAC, SF-36, ASA, FJS-12, Spielberger test.
- 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 for primary total knee arthroplasty will be introduced into clinical practice.
- Indications and contraindications for the use of this system in patients with gonarthrosis will be determined.
- The methodology of preoperative planning will be improved.
- The results of primary total knee arthroplasty using an active robotic system will be evaluated in comparison with the use of standard techniques and computer navigation.
- 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, the study of the learning curve.
- Conditions
- Knee Osteoarthritis
- Being tested
- total knee arthroplasty
- Keywords
- 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 arthroplastyOther
total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| total knee arthroplasty using the active robotic system | Active comparator | total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan Receives: Other: total knee arthroplasty |
| total knee arthroplasty using computer navigation | Active comparator | Primary total knee arthroplasty using computer navigation and intraoperation control system Receives: Other: total knee arthroplasty |
| total knee arthroplasty using the standard manual tekhnik | Active comparator | Primary total knee arthroplasty using the standard recommended set of instruments Receives: Other: total knee arthroplasty |
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Sep 2018
- Primary completionAug 2025 (estimated)
- Study completionAug 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
- 300 participants (actual)
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, First MSMU( I.M.Sechenov).The Department of Traumatology,Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667390
- Sponsor's protocol ID
- 199321
- Status last verified
- Apr 2024
- First submitted
- 3 Oct 2020
- Last updated
- 2 May 2024
- 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty Using an Active Robotic System
- ClinicalTrials.gov ID
- NCT04667390
- Acronym / sponsor ID
- 199321
- Conditions
- Knee Osteoarthritis
- Keywords
- total knee arthroplasty, the active robotic surgical system, robotic system in orthopedic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 14 Dec 2020 (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 and study primary knee arthroplasty using an active robotic system. The aim is to increase the efficiency of primary total knee arthroplasty using an active robotic surgical system. Traditional endoprosthetics of the knee joint (TKA) has now reached its maximum manufacturability and efficiency, but the accuracy of the performance depends on the skill and experience of the surgeon, as well as the efficiency of the cutting instrument (oscillator saw) when performing bone resection, the condition of the instrument and on the density of bone tissue fabric, which is highly variable. Modern RSS used in orthopedics include a robotic arm, robotic cutting devices with a computer navigation system, which are in active, semi-automatic or passive control mode. The main advantage of robotic systems is accurate preliminary planning using 3D modeling, use individual implant selection and virtual positioning.The active robotic surgical system TSolution-One allows participants to level the error in the positioning of the implant. The active robotic surgical system (ARSS) allows to correctly install the implant, which affects its service life, reduces the risks of postoperative complications, quickly returns to the usual way of life and forgets about the technical negative sensations and limitations that existed before the operation.It is planned to conduct an open-label retrospective and prospective clinical study in parallel observations.The study is planned to include 300 patients with osteoarthritis of the knee joint stage 3-4 (according to Kellgren-Lawrence). Investigators took three groups of patients, 100 patients each, and offered different options for total knee arthroplasty techniques.According to the research:-A clinical active robotic system for primary total knee arthroplasty will be introduced in Russia-There will be recommended indications and contraindications for this system in patients with gonarthrosis-The methodology of preoperative planning will be improved-The results of primary knee arthroplasty with an active robotic system will be evaluated in comparison with standard techniques and computer navigation-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 technologies were first introduced into medicine in the 1950s. The use of robotic systems in surgery begins with the use in neurosurgery. In 1985, the Programmable Universal Manipulation Arm (PUMA) 560 was introduced to perform CT-guided brain biopsy. In 1992, the Robodoc system (IBM) became the first orthopedic robotic system used in orthopedics for hip replacement, which subsequently improved the ability to automatically perform the stages of prosthetics. (Caspar system, Acrobot). Around the same time, the development of a robot for performing total knee arthroplasty began.
A distinctive feature of total knee arthroplasty (TKA) is the manufacturability of the stages and the high accuracy of surgical manipulations, which attracts the attention of many robotic surgical systems (RSS).
Traditional total knee arthroplasty (TKA) has now reached its maximum manufacturability and efficiency, but the accuracy of the performance depends on the skill and experience of the surgeon, as well as the accuracy of the cutting instrument (oscillator saw) when performing bone resection, the condition of the instrument and the density of the bone fabric, which is highly variable. The use of intramedullary guides during conventional surgery increases the risk of thromboembolic and cardiorespiratory complications. Computer navigation partially solves the problem of resection accuracy, infrared cameras read information from sensors and display a model with anatomical and kinematic features of the knee joint, which helps the surgeon to more accurately determine the level and direction of resection, but cannot ensure the accuracy of this manipulation and compliance with the preoperative plan.
Modern RSS used in orthopedics include a robotic arm, robotic cutting devices with a computer navigation system that operate in an active, semi-automatic, or passive control mode. The main advantage of robotic systems is accurate preoperative planning using 3D modeling, the possibility of individual selection of the implant and virtual positioning. Another advantage is the ability to accurately reproduce the preoperative plan during orthopedic surgery.
Today, active robotic surgical systems (ARSS) are used in clinical practice. ROBODOC / TSolution One. Robotic Surgical System (Curexo Technology, Fremont, Calif.), And Navio PFS (Blue Belt Technologies, Plymouth, Minnesota) Semi-Active Surgical Systems, OMNI Robotic System (OMNIlife Science, East Taunton, MA), RIO Robotic Arm Interactive Orthopedic System (Mako Surgical Corporation, Fort Lauderdale, Florida), ROSA Knee (Zimmer Zimmer Biomet, Montreal (Quebec), Canada).
The active robotic surgical system TSolution-One allows participants to level the error in the positioning of the implant. The accuracy of the filing is not affected by the manual skills of the surgeon, and does not depend on the density of bone tissue. Significant advantages of the system are: 1) precise preoperative breading; 2) rigid fixation of the limb, hip and tibia displacement sensors; 3) active autonomous milling without the participation of a surgeon; 4) accuracy of resection according to the preoperative plan; 5) rotation of the tibial component as in the preoperative plan; 6) no manual tools required; 7) postoperative control of the results of the operation. The active robotic surgical system (ARSS) allows participants to correctly install the implant, which affects its service life, reduces the risks of postoperative complications, the patient quickly returns to his usual way of life and forgets about those negative feelings and limitations that were before the operation.
The novelty of the proposed topic: For the first time in Russia, it is planned to introduce and study total knee arthroplasty using an active robotic system. Apply the use of a 3D patient model and the creation of an individual personalized preoperative plan using a robotic system for knee arthroplasty.
Aim and objectives of the research:
aim: To increase the efficiency of primary total knee arthroplasty using an active robotic surgical system.
objectives:
- To study the possibilities of an active robotic system for primary arthroplasty of the knee joint, to determine indications and contraindications for use in endoprosthetics of the knee joint in patients with primary arthrosis.
- To evaluate the technique of preoperative planning for total knee arthroplasty using an active robotic system in patients with arthrosis.
- To work out the technique of total knee arthroplasty using an active robotic system, compare with computer navigation and the traditional method.
- To evaluate the results of total knee arthroplasty using an active robotic system in comparison with the use of standard techniques and computer navigation.
- Examine complications
- Determine the place of the active robotic surgical unit in the total knee arthroplasty 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 300 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: LDFA, MPTA, Q, MAD;
- Preoperative 3D planning on the TPLAN workstation;
- Surgical treatment. 1) Primary total knee arthroplasty using the active robotic surgical system TSolution One, TCAT 2) Primary total knee arthroplasty using computer navigation 3) Primary total knee arthroplasty using the standard recommended set of instruments.
- Evaluation of patient treatment results according to scales: VAS, KSS, OKS, WOMAC, SF-36, ASA, FJS-12, Spielberger test.
- 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 for primary total knee arthroplasty will be introduced into clinical practice.
- Indications and contraindications for the use of this system in patients with gonarthrosis will be determined.
- The methodology of preoperative planning will be improved.
- The results of primary total knee arthroplasty using an active robotic system will be evaluated in comparison with the use of standard techniques and computer navigation.
- 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, the study of the learning curve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| total knee arthroplasty using the active robotic system | Active comparator | Other: total knee arthroplastytotal knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan |
| total knee arthroplasty using computer navigation | Active comparator | Other: total knee arthroplastyPrimary total knee arthroplasty using computer navigation and intraoperation control system |
| total knee arthroplasty using the standard manual tekhnik | Active comparator | Other: total knee arthroplastyPrimary total knee arthroplasty using the standard recommended set of instruments |
Who may qualify
- Ages
- 45 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 45 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 arthroplastytotal knee arthroplasty | Other | total knee arthroplasty using computer navigation, total knee arthroplasty using the active robotic system, total knee arthroplasty using the standard manual tekhnik |
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- 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
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 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 May 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT04667390, 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 May 2024.