NCT05712291

Brief Summary

For the first time, it is planned to create algorithms for working with a robotic system at different patient flow rates, optimize the use of computed tomography to assess bone density and pronounced osteophytes, develop an algorithm and tactics for treating bilateral osteoarthrosis of the knee joint using an active robotic system. Aim: optimization of total knee arthroplasty using robotic systems and improvement of treatment outcomes. Objectives: to develop algorithms for preoperative planning, surgical intervention using an active robotic system; to improve the technique of active robotic total knee arthroplasty in osteoporosis, osteosclerosis and pronounced osteophytes; to develop a tactic for the treatment of patients with bilateral osteoarthrosis of the knee joint using an active robotic system. It is planned to conduct an open-label retrospective and prospective clinical study in parallel observations.The study is planned to include 250 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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2022

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

February 21, 2023

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

January 26, 2023

Last Update Submit

February 20, 2023

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplastyrobotic total knee arthroplastythe active robotic surgical systemrobotic system in orthopedic

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

OTHER

Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan

Procedure: Total knee arthroplasty using the active robotic surgical systemDevice: TSolution One TCAT, and system for planning TPlan

total knee arthroplasty using the standard manual technic

OTHER

Primary total knee arthroplasty using the standard recommended set of instruments

Procedure: total knee arthroplasty using the standard manual technic

Interventions

Total knee arthroplasty using the active robotic surgical systemPROCEDURE

Total knee arthroplasty using the active robotic surgical system TSolution One TCAT, and system for planning TPlan

total knee arthroplasty using the active robotic system
TSolution One TCAT, and system for planning TPlanDEVICE

the active robotic surgical system TSolution One TCAT, and system for planning TPlan

total knee arthroplasty using the active robotic system
total knee arthroplasty using the standard manual technicPROCEDURE

total knee arthroplasty using the standard manual technic

total knee arthroplasty using the standard manual technic

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

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

    BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Andrey Gritsyuk, PhD

    The First MSMU (I.M.Sechenov).The Department of Traumatology, Orthopedics

    STUDY CHAIR

Central Study Contacts

Alexey Lychagin, PhD

CONTACT

89166389545clinic@travma.moscow

Maxim Gavlovsky

CONTACT

89100132671gavlovsky.m@yandex.ru

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

January 26, 2023

First Posted

February 3, 2023

Study Start

September 1, 2022

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

February 21, 2023

Record last verified: 2022-09

Locations

RU(1)