NCT00815243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 29, 2008

Completed
Last Updated

December 29, 2008

Status Verified

December 1, 2008

Enrollment Period

7 months

First QC Date

December 26, 2008

Last Update Submit

December 26, 2008

Conditions

Keywords

fracturecoxarthrosiscomplicationcongenital abnormalitiesbonejointtelemedicinetransportationdecision makingoutcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • "Relevance of Telemedicine Consultation" Questionnaire

    one year

Study Arms (3)

Telemed

EXPERIMENTAL

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

Procedure: Telemedicine consultationProcedure: 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

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

Procedure: Treatment plan

Interventions

Standard synchronous or asynchronous telemedicine consultations according recommendations and best practice models of ISfTeH

Also known as: Telemedicine work station according national recommendations, Best practice models for teletrauma recognised by ISFTEH
Telemed

Treatment plan include diagnostic tests (physical examination, laboratory tests, xray, CT, MRI), medications and surgical treatment (debridements, osteosynthesis, arthroplasty, ORIF etc)

Also known as: Ilizarov frame, AO-Plate osteosynthesis, Intermedullar nailing, Total cemented/uncemented hip arthroplasty
ExternalControlInternalControlTelemed

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis is not present
  • Patient's self-request for teleconsultations
  • No reliable feed-back with attending physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Volnovakha Central Area Hospital

Volnovakha, Donetsk Oblast, 85700, Ukraine

Location

Gorlovka Municipal Hospital N2

Gorlovka, Donetskya Oblast, 84600, Ukraine

Location

Central Clinical Municipal Hospital N6

Donetsk, 83000, Ukraine

Location

Donetsk R&D Institute of Traumatology and Orthopedics

Donetsk, 83048, Ukraine

Location

Clinics of Maxillo-Fascial Surgery of DNMU

Donetsk, 83114, Ukraine

Location

Related Publications (2)

  • Vladzymyrskyy AV. Four years' experience of teleconsultations in daily clinical practice. J Telemed Telecare. 2005;11(6):294-7. doi: 10.1258/1357633054893337.

    PMID: 16168165BACKGROUND
  • Vladzymyrskyy AV. Our experience with telemedicine in traumatology and orthopedics. Ulus Travma Acil Cerrahi Derg. 2004 Jul;10(3):189-91.

    PMID: 15286891BACKGROUND

Related Links

MeSH Terms

Conditions

Wounds and InjuriesJoint DiseasesFractures, BoneOsteoarthritis, HipCongenital Abnormalities

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesOsteoarthritisArthritisRheumatic DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Anton V Vladzymyrskyy, M.D.

    R&D Institute of Traumatology and Orthopedics

    PRINCIPAL INVESTIGATOR
  • Volodymyr G Klymovytskyy, Professor

    R&D Institute of Traumatology and Orthopedics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2008

First Posted

December 29, 2008

Study Start

September 1, 2007

Primary Completion

April 1, 2008

Study Completion

September 1, 2008

Last Updated

December 29, 2008

Record last verified: 2008-12

Locations