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Personalized Approach to Robotic Total Knee Arthroplasty

NCT05750784 · I.M. Sechenov First Moscow State Medical University · Updated 2 March 2023

What is being tested
Total knee arthroplasty using the active robotic surgical system
For
Knee Osteoarthritis
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 21 years to 90 years. About 150 people. The full rules are on the registry page.
Where
Russia
When
Starts or started 1 Sept 2022, ends 31 Aug 2025. Registered 2 March 2023.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT05750784

Sites

  • University clinical hospital №1 I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster SurgeryMoscow, Russia