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Telemedicine Consultation in Trauma and Orthopedic (TeleTO)

This study has been completed.
Sponsor:
Information provided by:
Donetsk National Medical University
ClinicalTrials.gov Identifier:
NCT00815243
First received: December 26, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted

December 26, 2008
December 26, 2008
September 2007
April 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
"Relevance of Telemedicine Consultation" Questionnaire [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Telemedicine Consultation in Trauma and Orthopedic
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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Trauma
  • Congenital Bone and Joint Abnormalities
  • Joint Diseases
  • Orthopedic Surgery Complications
  • 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
  • Experimental: Telemed
    Group of trauma&orthopedic patients - for determination of clinical strategy and treatment plan telemedicine will be used
    Interventions:
    • Procedure: Telemedicine consultation
    • Procedure: Treatment plan
  • 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
    Intervention: Procedure: Treatment plan
  • 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
    Intervention: Procedure: Treatment plan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
September 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Ukraine
 
NCT00815243
1-2007-2011
No
Anton Vladzymyrskyy, M.D., Head of Dep. of Informaics and Telemedicine, Donetsk R&D Institute of Traumatology and Orthopedics
Donetsk National Medical University
Not Provided
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
Donetsk National Medical University
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP