Clinical trial NCT00815243: Telemedicine Consultation in Trauma and Orthopedic
Official title: Study of Clinical Workflow Changes, Anatomical and Functional Outcomes Due to Telemedicine Consultations in Trauma and Orthopedic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Congenital Bone and Joint Abnormalities
Joint Diseases
Orthopedic Surgery Complications
Keywords: fracture
coxarthrosis
complication
congenital abnormalities
bone
joint
telemedicine
transportation
decision making
outcomes
Lead sponsor: Donetsk National Medical University
Sponsor class: OTHER
First posted: 2008-12-29
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
timeFrame: one year
Secondary outcomes:
measure: "Relevance of Telemedicine Consultation" Questionnaire
timeFrame: one year
Other outcomes:
Locations:
city: Volnovakha
country: Ukraine
facility: Volnovakha Central Area Hospital
state: Donetskaya oblast
city: Gorlovka
country: Ukraine
facility: Gorlovka Municipal Hospital N2
state: Donetskya oblast
city: Donetsk
country: Ukraine
facility: Central Clinical Municipal Hospital N6
city: Donetsk
country: Ukraine
facility: Donetsk R&D Institute of Traumatology and Orthopedics
city: Donetsk
country: Ukraine
facility: Clinics of Maxillo-Fascial Surgery of DNMU
Study officials:
affiliation: R&D Institute of Traumatology and Orthopedics
name: Anton V Vladzymyrskyy, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: R&D Institute of Traumatology and Orthopedics
name: Volodymyr G Klymovytskyy, Professor
role: STUDY_DIRECTOR
References:
citation: Vladzymyrskyy AV. Four years' experience of teleconsultations in daily clinical practice. J Telemed Telecare. 2005;11(6):294-7. doi: 10.1258/1357633054893337.
citation: Vladzymyrskyy AV. Our experience with telemedicine in traumatology and orthopedics. Ulus Travma Acil Cerrahi Derg. 2004 Jul;10(3):189-91.