Personalized Approach to Robotic Total Knee Arthroplasty
1 other identifier
interventional
150
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Sep 2022
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedMarch 2, 2023
September 1, 2022
3 years
February 20, 2023
February 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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)
2 months after surgery
Implant position assessment
CT scanning
6 months after surgery
Implant position assessment
CT scanning
12 months after surgery
Secondary Outcomes (5)
Quality of life and knee function assessment
2,6,12 months after surgery
Quality of life assessment (joint awareness after surgery)
2,6,12 months after surgery
Quality of life assessment (the condition of patients)
2,6,12 months after surgery
Pain assessment
2,6,12 months after surgery
Quality of life assessment (an individual's activities of daily living)
2,6,12 months after surgery
Study Arms (2)
total knee arthroplasty using the active robotic system using the kinematic alignment concept
OTHERTotal 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
OTHERTotal knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan
Interventions
Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery
Moscow, 119991, Russia
Related Publications (2)
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
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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 2, 2023
Study Start
September 1, 2022
Primary Completion
August 31, 2025
Study Completion
August 31, 2025
Last Updated
March 2, 2023
Record last verified: 2022-09