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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
  Purpose

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.


Condition Intervention
Trauma
Congenital Bone and Joint Abnormalities
Joint Diseases
Orthopedic Surgery Complications
 Procedure: Telemedicine consultation
Procedure: Treatment plan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Clinical Workflow Changes, Anatomical and Functional Outcomes Due to Telemedicine Consultations in Trauma and Orthopedic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Donetsk National Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • "Relevance of Telemedicine Consultation" Questionnaire [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815243

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

Publications:

Responsible Party: Anton Vladzymyrskyy, M.D., Head of Dep. of Informaics and Telemedicine, Donetsk R&D Institute of Traumatology and Orthopedics
ClinicalTrials.gov Identifier: NCT00815243     History of Changes
Other Study ID Numbers: 1-2007-2011
Study First Received: December 26, 2008
Last Updated: December 26, 2008
Health Authority: Ukraine: Ministry of Health

Keywords provided by Donetsk National Medical University:
fracture
coxarthrosis
complication
congenital abnormalities
bone
 joint
telemedicine
transportation
decision making
outcomes

Additional relevant MeSH terms:
Congenital Abnormalities
Joint Diseases
Wounds and Injuries
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013