Telemedicine Consultation in Trauma and Orthopedic (TeleTO)

December 26, 2008 updated by: Donetsk National Medical University

Study of Clinical Workflow Changes, Anatomical and Functional Outcomes Due to Telemedicine Consultations in Trauma and Orthopedic

The purpose of this study is to determine whether telemedicine consultations (lead by standard scheme)allows to increase quality of anatomical and functional outcomes and improve clinical work-flow at patients with acute bone and joint trauma, hip pathology and congenital orthopedics abnormalities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Levels of bad outcomes, untimely death and disability due to acute trauma, specific orthopedic pathology (congenital, coxarthrosis) and non-efficient organisation of clinical work-flow are still very high (especially in rural areas). Standard telemedicine work stations (with special protocols and manuals for original approach to telemedicine activity organisation and management) will be placed into small municipal and rural hospitals. Telemedicine links will be established between 3rd level Trauma&Ortho center and remote sites. Synchronous and asynchronous teleconsultations will be perform for help in evidence-based timely clinical decisions, continual support of clinical wor-flow and treatment process.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Donetsk, Ukraine, 83000
        • Central Clinical Municipal Hospital N6
      • Donetsk, Ukraine, 83048
        • Donetsk R&D Institute of Traumatology and Orthopedics
      • Donetsk, Ukraine, 83114
        • Clinics of Maxillo-Fascial Surgery of DNMU
    • Donetskaya oblast
      • Volnovakha, Donetskaya oblast, Ukraine, 85700
        • Volnovakha Central Area Hospital
    • Donetskya oblast
      • Gorlovka, Donetskya oblast, Ukraine, 84600
        • Gorlovka Municipal Hospital N2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of injury of locomotorium (isolated or polytrauma)
  • Clinical diagnosis of bone and joint congenital abnormalities or intranatal injury
  • Clinical diagnosis of knee, hip arthrosis
  • Clinical diagnosis of complication of surgery (unstable, fracture of construction etc)
  • Diagnosis is already present
  • Primary decision of clinical strategy have to be done (transportation, level of care, method of treatment, surgery peculiarities)
  • Indications for teleconsultations determined by physician

Exclusion Criteria:

  • Diagnosis is not present
  • Patient's self-request for teleconsultations
  • No reliable feed-back with attending physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemed
Group of trauma&orthopedic patients - for determination of clinical strategy and treatment plan telemedicine will be used
Procedure: Telemedicine consultation
Standard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH
Other Names:
  • Telemedicine work station according national recommendations
  • Best practice models for teletrauma recognised by ISFTEH
Procedure: Treatment plan
Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
Other Names:
  • Ilizarov frame
  • AO-Plate osteosynthesis
  • Intermedullar nailing
  • Total cemented/uncemented hip arthroplasty
Active Comparator: InternalControl
Group of trauma&orthopedic patients from 3rd level trauma center - for determination of clinical strategy and treatment plan usual clinical approaches will be used
Procedure: Treatment plan
Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
Other Names:
  • Ilizarov frame
  • AO-Plate osteosynthesis
  • Intermedullar nailing
  • Total cemented/uncemented hip arthroplasty
Active Comparator: ExternalControl
Group of trauma&orthopedic patients from 1-2rd level trauma centers (in rural and small municipal hospitals) - for determination of clinical strategy and treatment plan personal arriving of the expert by the car (so-called Urgent Expert Care) will be used
Procedure: Treatment plan
Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
Other Names:
  • Ilizarov frame
  • AO-Plate osteosynthesis
  • Intermedullar nailing
  • Total cemented/uncemented hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scales for outcomes in trauma and orthopedic (Harris Hip Score, national protocol for trauma outcomes). Sets of criteria: ARR, RRR, ABІ, RBI, RR, odds ratio and NNT
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
"Relevance of Telemedicine Consultation" Questionnaire
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Donetsk National Medical University

Investigators

  • Principal Investigator: Anton V Vladzymyrskyy, M.D., R&D Institute of Traumatology and Orthopedics
  • Study Director: Volodymyr G Klymovytskyy, Professor, R&D Institute of Traumatology and Orthopedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 26, 2008

First Submitted That Met QC Criteria

December 26, 2008

First Posted (Estimate)

December 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 29, 2008

Last Update Submitted That Met QC Criteria

December 26, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2007-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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