Personalized Approach to Robotic Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Implant position assessment
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Availability of written informed consent of the patient to participate in the study;
- •Patients with stage 3-4 osteoarthritis of the knee joint (according to Kellgren-Lawrence).
- •Men and women from 21 to 90 years old.
- •Pain in the knee joint above 3 points according to VAS
- •Opportunity for observations during the entire study period (12 months);
- •Mental adequacy, ability, willingness to cooperate and to fulfill the doctor's recommendations.
Exclusion Criteria
- •Refusal of the patient from surgical treatment;
- •Presence of contraindications to surgical treatment;
- •Severe forms of diabetes mellitus (glycosylated hemoglobin> 9%);
- •Diseases of the blood (thrombopenia, thrombocytopenia, anemia with Hb <90 g / l);
- •The patient's unwillingness to conscious cooperation.
- •Refusal of the patient to participate in the study;
- •Non-compliance with the hospital regimen, according to the order of the Ministry of Health and Social Development of Russia dated 01.08.07, No. 514;
- •The impossibility of observing the patient within the control period after the operation.
Arms & Interventions
total knee arthroplasty using the active robotic system using the kinematic alignment concept
Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan
Intervention: Total knee arthroplasty using the active robotic surgical system (Procedure)
total knee arthroplasty using the active robotic system using the mechanical alignment concept
Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan
Intervention: Total knee arthroplasty using the active robotic surgical system (Procedure)
Outcomes
Primary Outcomes
Implant position assessment
Time Frame: 12 months after surgery
CT scanning
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
Secondary Outcomes
- 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)