TraumaTeleTONCT00815243
Telemedicine Consultation in Trauma and Orthopedic
A study testing Telemedicine consultation and Treatment plan in people with Trauma and Congenital Bone and Joint Abnormalities, run by Donetsk National Medical University at 5 sites in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Congenital Bone and Joint Abnormalities, Joint Diseases
- What is being tested?
- Telemedicine consultation and Treatment plan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesUkraine
- Study dates
- Sep 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis is not present
- Patient's self-request for teleconsultations
- No reliable feed-back with attending physician
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ukraine5 sites
Central Clinical Municipal Hospital N6
Donetsk, 83000
Donetsk R&D Institute of Traumatology and Orthopedics
Donetsk, 83048
Clinics of Maxillo-Fascial Surgery of DNMU
Donetsk, 83114
Gorlovka Municipal Hospital N2
Gorlovka, Donetskya Oblast, 84600
Volnovakha Central Area Hospital
Volnovakha, Donetsk Oblast, 85700
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma, Congenital Bone and Joint Abnormalities, Joint Diseases, Orthopedic Surgery Complications
- Being tested
- Telemedicine consultation, Treatment plan
- Keywords
- fracture, coxarthrosis, complication, congenital abnormalities, bone, joint, telemedicine, transportation, decision making, outcomes
- Medical subject headings
- Wounds and Injuries, Joint Diseases, Fractures, Bone, Osteoarthritis, Hip, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine consultationProcedure or surgery
Also called Telemedicine work station according national recommendations, Best practice models for teletrauma recognised by ISFTEH
Standard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH
Treatment planProcedure or surgery
Also called Ilizarov frame, AO-Plate osteosynthesis, Intermedullar nailing, Total cemented/uncemented hip arthroplasty
Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)
| Study group | Role | What they receive |
|---|---|---|
| Telemed | Experimental | Group of trauma\&orthopedic patients - for determination of clinical strategy and treatment plan telemedicine will be used Receives: Procedure: Telemedicine consultation; Procedure: Treatment plan |
| InternalControl | Active comparator | Group of trauma\&orthopedic patients from 3rd level trauma center - for determination of clinical strategy and treatment plan usual clinical approaches will be used Receives: Procedure: Treatment plan |
| ExternalControl | Active comparator | 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 Receives: Procedure: Treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
"Relevance of Telemedicine Consultation" Questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2008 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donetsk National Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Anton V Vladzymyrskyy, M.D., Principal investigator, R&D Institute of Traumatology and OrthopedicsVolodymyr G Klymovytskyy, Professor, Study director, R&D Institute of Traumatology and Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815243
- Sponsor's protocol ID
- 1-2007-2011
- Acronym
- TeleTO
- Status last verified
- Dec 2008
- First submitted
- 26 Dec 2008
- Last updated
- 29 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Vladzymyrskyy AV. Four years' experience of teleconsultations in daily clinical practice. J Telemed Telecare. 2005;11(6):294-7. doi: 10.1258/1357633054893337.
PubMed 16168165Vladzymyrskyy AV. Our experience with telemedicine in traumatology and orthopedics. Ulus Travma Acil Cerrahi Derg. 2004 Jul;10(3):189-91.
PubMed 15286891
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Workflow Changes, Anatomical and Functional Outcomes Due to Telemedicine Consultations in Trauma and Orthopedic
- ClinicalTrials.gov ID
- NCT00815243
- Acronym / sponsor ID
- TeleTO / 1-2007-2011
- Conditions
- Trauma, Congenital Bone and Joint Abnormalities, Joint Diseases, Orthopedic Surgery Complications
- Keywords
- fracture, coxarthrosis, complication, congenital abnormalities, bone, joint, telemedicine, transportation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Donetsk National Medical UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 29 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telemed | Experimental | Procedure: Telemedicine consultation, Procedure: Treatment planGroup of trauma\&orthopedic patients - for determination of clinical strategy and treatment plan telemedicine will be used |
| InternalControl | Active comparator | Procedure: Treatment planGroup of trauma\&orthopedic patients from 3rd level trauma center - for determination of clinical strategy and treatment plan usual clinical approaches will be used |
| ExternalControl | Active comparator | Procedure: Treatment planGroup 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis is not present
- Patient's self-request for teleconsultations
- No reliable feed-back with attending physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine consultationAlso: Telemedicine work station according national recommendations, Best practice models for teletrauma recognised by ISFTEHStandard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH | Procedure or surgery | Telemed |
| Treatment planAlso: Ilizarov frame, AO-Plate osteosynthesis, Intermedullar nailing, Total cemented/uncemented hip arthroplastyTreatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc) | Procedure or surgery | ExternalControl, InternalControl, Telemed |
Primary outcome
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
1 secondary outcome
"Relevance of Telemedicine Consultation" Questionnaire
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2008.
- Background: PubMed 16168165Vladzymyrskyy AV. Four years' experience of teleconsultations in daily clinical practice. J Telemed Telecare. 2005;11(6):294-7. doi: 10.1258/1357633054893337.
- Background: PubMed 15286891Vladzymyrskyy AV. Our experience with telemedicine in traumatology and orthopedics. Ulus Travma Acil Cerrahi Derg. 2004 Jul;10(3):189-91.
- Best Practice Models in Telemedicine for Trauma (recognized by ISFTEH)Link provided by the sponsor.
- Med-e-Tel Digital Library: 2005-2007 presentations and papers about telemedicine activity of investigatorsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton V Vladzymyrskyy, M.D. principal investigator
R&D Institute of Traumatology and Orthopedics
Volodymyr G Klymovytskyy, Professor study director
R&D Institute of Traumatology and Orthopedics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine consultation and Treatment plan in people with Trauma and Congenital Bone and Joint Abnormalities, run by Donetsk National Medical University at 5 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00815243, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2008.