Spine FA3 - a Prospective, International, Multicenter Cohort Study on Treatment of of AO A3 Thoracolumbar Fractures (FA3)
11 augusti 2020 uppdaterad av: AO Clinical Investigation and Publishing Documentation
Comparison of Surgical Versus Conservative Treatment of AO Type A3 Thoracolumbar Fractures Without Neurological Deficits Prospective, International, Multicenter Cohort Study
Thoracolumbar fractures are the most common spinal fractures with an average annual incidence between 18 and 30 per 100'000 inhabitants.
The majority of these fractures are AO type A3 ("burst fractures").
Although patients with burst fractures report a reduced quality of life and chronic pain, there is no clear evidence whether surgical or conservative treatment offer better functional and back-pain related outcomes.
The indications for the selection of an ideal treatment for these fractures without neurological deficits remain controversial.
The purpose of this study is to evaluate whether patients with thoracolumbar fractures without neurological deficit being surgically treated show faster recovery and better improvement of function than patients being conservatively treated.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
38
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Curitiba, Brasilien
- Hospital Universitaria Cajuru
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Porto Alegre, Brasilien
- Hospital Cristo Redentor
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São Paulo, Brasilien
- Hospital Santa Marcelina
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Santiago de Chile, Chile
- Hospital Cristo Redentor
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Catania, Italien
- Azienda Ospedaliero - Universitaria Policlinico
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Almada, Portugal
- Hospital Garcia e Orta, EPE
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-
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Liberec, Tjeckien
- Krajská nemocnice Liberec
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Munich, Tyskland
- Klinikum rechts der Isar der Technischen Universität München
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
140 subjects patients with thoracolumbar fractures will be assigned to ei-ther conservative or surgical treatment depending on the surgeon's decision.
Patients will be treated at each institution per standard of care.
Surgeons will use their expertise and preferences to determine the method of surgical or conservative intervention.
Beskrivning
Inclusion Criteria:
- Age 18-65 years
Diagnosis of single or multiple stable thoracolumbar fracture(s)
- Level T10- L3
- Type AO A3 or A4
- Radiologically confirmed by Rx or CT
- Fracture induced kyphotic deformity lower or equal to 20-35 degrees
- Definitive treatment (surgical or conservative) within 10 days after injury
- American Spinal Injury Association (ASIA) Impairment Scale = E (normal )
- Ability to understand patient information / informed consent form
- Willingness and ability to participate in the clinical investigation including imaging and follow-up procedures (FUs)
- Signed informed consent
Exclusion Criteria:
- Open fracture
- Polytrauma
- Pathologic fracture
- Disruption of the posterior ligamentous complex between T10 and L3
- Clinically evident osteoporosis as assessed by the investigator
- Spinal luxation
- Associated severe lesions as assessed by the investigator
- Spinal lesion due to gun or projectile
- Pre-existing spinal column deformity
- Prior spinal surgeries
- BMI > 40 kg/m2
- Any severe medically not managed systemic disease
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reli-able assessment
- Pregnancy or women planning to conceive within the study period
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Surgical treatment
Surgical treatment according to one of the following:
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Andra namn:
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Conservative treatment
Conservative treatment according to hospital's standard of care
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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Roland-Morris Disability Questionnaire (RMDQ)
Tidsram: 6 week follow up
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Improvement in functional outcome from baseline to 6 week follow up (FU) measured with the Roland-Morris Disability Questionnaire (RMDQ)
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6 week follow up
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Back pain related disability (Roland-Morris Disability Questionnaire RMDQ)
Tidsram: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Pain (Numeric Rating Scale (NRS))
Tidsram: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU
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Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months FU
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Radiologic progress taking into account RX, CT and optionally MRI
Tidsram: baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months
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baseline and at follow up after 6 weeks, 3, 6, 12 and 24 months
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Quality of return to work (Denis Work Scale)
Tidsram: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Time to return to work
Tidsram: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Conservative treatment failure rate (eg, change to surgical treatment)
Tidsram: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Rates of local adverse events (AE)
Tidsram: Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Assessed at baseline, 6 weeks, 3, 6, 12 and 24 months follow up
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Giuseppe Barbagallo, MD, Azienda Ospedaliero - Universitaria Policlinico, Catania, Italy
- Huvudutredare: Emiliano Vialle, MD, Catholic University of Parana - Curitiba, Brazil
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2013
Primärt slutförande (Faktisk)
1 mars 2015
Avslutad studie (Faktisk)
1 december 2015
Studieregistreringsdatum
Först inskickad
14 december 2012
Först inskickad som uppfyllde QC-kriterierna
14 december 2012
Första postat (Uppskatta)
18 december 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 augusti 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 augusti 2020
Senast verifierad
1 augusti 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Spine FA3
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