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Telemedicine Consultation in Trauma and Orthopedic (TeleTO)

Primary Purpose

Trauma, Congenital Bone and Joint Abnormalities, Joint Diseases

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Telemedicine consultation
Treatment plan
Sponsored by
Donetsk National Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring fracture, coxarthrosis, complication, congenital abnormalities, bone, joint, telemedicine, transportation, decision making, outcomes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Volnovakha Central Area Hospital
  • Gorlovka Municipal Hospital N2
  • Central Clinical Municipal Hospital N6
  • Donetsk R&D Institute of Traumatology and Orthopedics
  • Clinics of Maxillo-Fascial Surgery of DNMU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Telemed

InternalControl

ExternalControl

Arm Description

Group of trauma&orthopedic patients - for determination of clinical strategy and treatment plan telemedicine will be used

Group of trauma&orthopedic patients from 3rd level trauma center - for determination of clinical strategy and treatment plan usual clinical approaches will be used

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

Outcomes

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

Secondary Outcome Measures

"Relevance of Telemedicine Consultation" Questionnaire

Full Information

First Posted
December 26, 2008
Last Updated
December 26, 2008
Sponsor
Donetsk National Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00815243
Brief Title
Telemedicine Consultation in Trauma and Orthopedic
Acronym
TeleTO
Official Title
Study of Clinical Workflow Changes, Anatomical and Functional Outcomes Due to Telemedicine Consultations in Trauma and Orthopedic
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Donetsk National Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Congenital Bone and Joint Abnormalities, Joint Diseases, Orthopedic Surgery Complications
Keywords
fracture, coxarthrosis, complication, congenital abnormalities, bone, joint, telemedicine, transportation, decision making, outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemed
Arm Type
Experimental
Arm Description
Group of trauma&orthopedic patients - for determination of clinical strategy and treatment plan telemedicine will be used
Arm Title
InternalControl
Arm Type
Active Comparator
Arm Description
Group of trauma&orthopedic patients from 3rd level trauma center - for determination of clinical strategy and treatment plan usual clinical approaches will be used
Arm Title
ExternalControl
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Telemedicine consultation
Other Intervention Name(s)
Telemedicine work station according national recommendations, Best practice models for teletrauma recognised by ISFTEH
Intervention Description
Standard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH
Intervention Type
Procedure
Intervention Name(s)
Treatment plan
Other Intervention Name(s)
Ilizarov frame, AO-Plate osteosynthesis, Intermedullar nailing, Total cemented/uncemented hip arthroplasty
Intervention Description
Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
"Relevance of Telemedicine Consultation" Questionnaire
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton V Vladzymyrskyy, M.D.
Organizational Affiliation
R&D Institute of Traumatology and Orthopedics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Volodymyr G Klymovytskyy, Professor
Organizational Affiliation
R&D Institute of Traumatology and Orthopedics
Official's Role
Study Director
Facility Information:
Facility Name
Volnovakha Central Area Hospital
City
Volnovakha
State/Province
Donetskaya oblast
ZIP/Postal Code
85700
Country
Ukraine
Facility Name
Gorlovka Municipal Hospital N2
City
Gorlovka
State/Province
Donetskya oblast
ZIP/Postal Code
84600
Country
Ukraine
Facility Name
Central Clinical Municipal Hospital N6
City
Donetsk
ZIP/Postal Code
83000
Country
Ukraine
Facility Name
Donetsk R&D Institute of Traumatology and Orthopedics
City
Donetsk
ZIP/Postal Code
83048
Country
Ukraine
Facility Name
Clinics of Maxillo-Fascial Surgery of DNMU
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
16168165
Citation
Vladzymyrskyy AV. Four years' experience of teleconsultations in daily clinical practice. J Telemed Telecare. 2005;11(6):294-7. doi: 10.1258/1357633054893337.
Results Reference
background
PubMed Identifier
15286891
Citation
Vladzymyrskyy AV. Our experience with telemedicine in traumatology and orthopedics. Ulus Travma Acil Cerrahi Derg. 2004 Jul;10(3):189-91.
Results Reference
background
Links:
URL
http://www.medetel.lu/index.php?rub=library_country&page=ukraine
Description
Med-e-Tel Digital Library: 2005-2007 presentations and papers about telemedicine activity of investigators

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Telemedicine Consultation in Trauma and Orthopedic

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