Telemedicine Consultation in Trauma and Orthopedic

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Trauma, Congenital Bone and Joint Abnormalities, Joint Diseases, Orthopedic Surgery Complications

Intervention / Treatment
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* Procedure: Telemedicine consultation
* Procedure: Treatment plan


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemed<br>Group of trauma&orthopedic patients - for determination of clinical strategy and treatment plan telemedicine will be used | Procedure: Telemedicine consultation<br>* Standard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH<br>* Other names: Best practice models for teletrauma recognised by ISFTEH;Procedure: Treatment plan<br>* Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)<br>* Other names: Total cemented/uncemented hip arthroplasty;|
| Active Comparator: InternalControl<br>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<br>* Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)<br>* Other names: Total cemented/uncemented hip arthroplasty;|
| Active Comparator: ExternalControl<br>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<br>* Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)<br>* Other names: Total cemented/uncemented hip arthroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relevance of Telemedicine Consultation Questionnaire |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fracture, coxarthrosis, complication, congenital abnormalities, bone, joint, telemedicine, transportation, decision making, outcomes