- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01741168
Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury
30. november 2012 opdateret af: The London Spine Centre
TLSO Versus No Orthosis for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury: A Multicenter Prospective Randomized Equivalence Trial
Braces have been used o treat stable (not requiring surgery) burst fractures with much success.
Recently questions have been raised in regards to the importance of the brace.
Some studies have results that suggest a brace is not important in having a good outcome.
However, this has never been proven.
This study is being conducted to see whether or not wearing a brace is important to having a good outcome.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this study is to prospectively compare the outcome between patients randomly assigned to a thoracolumbosacral orthosis (TLSO) treatment group or no orthosis (NO) treatment group, for the management of an acute AO type A3 thoracolumbar fracture.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
97
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Spine Centre
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
16 år til 60 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- AO A3 burst fracture between T10 and L3 with associated kyphotic deformity <35 degrees
- neurologically intact or isolated nerve root deficit
- age 16-60 years
- enrollment within 3 days of injury
Exclusion Criteria:
- neurological deficit
- can not comply with brace wearing (pregnancy/body mass index >40)
- mobilized with or without a brace prior to recruitment
- suffered a pathologic or open fracture
- alcohol or drug abusers
- had previous injury or surgery to the thoracolumbar region
- unable to complete the questionnaires
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: TLSO
TLSO brace 8-10 weeks
|
Patients in the TLSO arm will remain on bed rest until fitted with a TLSO.
They will wear the TLSO for 8-10 weeks and mobilized in the brace by a physiotherapist.
Andre navne:
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Eksperimentel: No Orthosis
|
Patients in the No Orthosis group will be mobilized immediately as tolerated by a physiotherapist with restrictions to limit bending or rotating through their trunk.
They will be encouraged to return to normal activities after 8 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Roland Morris Disability Questionnaire
Tidsramme: 3 months post fracture
|
The primary outcome measure is the Roland Morris Disability Questionnaire (RMDQ) administered at 3 months post fracture.
The RMDQ evaluates physical disability secondary to low back pain and is validated, simple to administer, sensitive, and reliable.
The questionnaire evaluates 24 items to derive a score that varies between zero (no disability) and twenty-four (severe disability).
Three months was chosen because it is the time point at which we expect a significant functional recovery and readiness to resume most normal activities.
|
3 months post fracture
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
SF-36 physical component summary score
Tidsramme: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years
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enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2years
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SF-36 mental component summary score
Tidsramme: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
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enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years
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VAS pain score
Tidsramme: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
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enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
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Satisfaction with Treatment
Tidsramme: enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
Overall satisfaction with treatment was assessed on a seven point scale, using the sentence, "All things considered, how satisfied are you with the results of your recent treatment for your spine fracture?"
This is a recommended tool for assessing global satisfaction.
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enrollment, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2005
Primær færdiggørelse (Faktiske)
1. september 2010
Studieafslutning (Faktiske)
1. september 2011
Datoer for studieregistrering
Først indsendt
22. november 2012
Først indsendt, der opfyldte QC-kriterier
30. november 2012
Først opslået (Skøn)
4. december 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. december 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. november 2012
Sidst verificeret
1. november 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11421
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med TLSO
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Aspen Medical ProductsAfsluttet
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Duke UniversityAfsluttet
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The University of Hong KongThe Hong Kong Polytechnic UniversityRekrutteringTeenagers idiopatisk skolioseHong Kong
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St. Louis UniversityAfsluttetKompressionsfraktur af thorax hvirvellegeme | Thorax fraktur | Lændefraktur | Kompressionsbrud af lændehvirvelsøjlen | Brustbrud af thoraxhvirvel | Brustbrud af lændehvirvelForenede Stater
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Shriners Hospitals for ChildrenUkendtSkolioseForenede Stater
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Medipol UniversityRekrutteringSkoliose | Dyrke motion | Lungerehabilitering | Spinal muskelatrofi type I | Brystdeformiteter | Spinal ortoseKalkun