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van CCT (UK)


A stable fracture of the spine, treatment with or without a brace


- candidate number24115
- NTR NumberNTR5777
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mrt-2016
- Secondary IDsNL55565.028.15 
- Public TitleA stable fracture of the spine, treatment with or without a brace
- Scientific TitleThoracolumbar burstfractures, orthesis or no orthesis
- ACRONYMBONO
- hypothesisWe aim to study the use of braces for thoracolumbar burstfractures, not only by measuring the functional scores and the effect of the bracing or functional treatment on the increase in kyphosis angle, but also on (health related) quality of life and health economics. We hypothesize that no treatment is superior over one other by means of function, or pain.
- Healt Condition(s) or Problem(s) studiedFracture , Brace, Backsurgery
- Inclusion criteria- 18-65 years
- Th10-L4
- AO type A3 or A4 type fractures
- Single level
- Kyphosis < 35 ° at first analysis
- Neurologically intact
- Adequate trauma
- Exclusion criteria- Inadequate knowledge of the Dutch language
- Multitrauma, which asks for multidisciplinary treatment
- Inability to wear a brace due to overweight (BMI> 35)
- Known osteoporosis
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-mrt-2016
- planned closingdate1-jul-2017
- Target number of participants122
- InterventionsSubjects will wear a TLSO for 6 weeks 24 hours a day or they will not. The TLSO is customised and fitted on admission by the orthopaedic surgeon on call and/ or the supplier. After 6 weeks the subjects in the TLSO group will decrease and stop the use of the orthesis. Depending on their pain complaints patients will be admitted to the hospital and will get adequate pain management following local protocol.
- Primary outcomeFunction score (Oswestry Disability Index) 6 months after trauma.
- Secondary outcome- WHOQoL- Brev
- Short Form-36
- EQ5D
- VAS-pain
- Increase of kyphosis on X-ray (AP and lateral view)
- iMCQ (iMTA Medical Consumption Questionnaire)
- iPCQ (iMTA Productivity Cost Questionnaire)
- WAI (Work Ability Index)
- Length of hospital stay.
- Timepointsadmission
1-2 weeks
6 weeks
3 months
6 months
1 year
2 years
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Wouter Bakker
- CONTACT for SCIENTIFIC QUERIES Wouter Bakker
- Sponsor/Initiator Elisabeth-Twee Steden ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Experiment Topzorg
- Publications
- Brief summaryRationale: Thoracolumbar burst fractures are frequently seen in the trauma population, they have a large impact on patient’s wellbeing and are a large economic burden to society. Thoracolumbar burst fractures might not need the standard care of brace immobilization for adequate treatment and a functional treatment might lead to same or better functional outcomes. Besides that, with functional outcome length of hospital stay might decrease and it might also be cost effective compared to bracing.

Objective: We aim to study the use of braces for thoracolumbar burstfractures, not only by measuring the functional scores and the effect of the bracing or functional treatment on the increase in kyphosis angle, but also on (health related) quality of life and health economics. We hypothesize that no treatment is superior over one other by means of function, or pain.

Study design: This project is a randomised controlled trial comparing brace and no brace treatment on function, kyphosis angle, pain, QoL, and costs.

Study population: For the RCT patients between 18 and 65, with a single level thoracolumbar burst fracture will be included. The fracture has to have a kyphosis angle of less than 35 degrees and patient has to be neurologically intact. Patients are excluded when they are overweight (BMI> 35), need multidisciplinary treatment due to multitrauma, or have inadequate knowledge of the Dutch language. Patients included in the brace group will automatically take part in a brace compliance study.

Intervention: One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the other group receives no TLSO

Main study parameters/endpoints: The primary outcome of this study is the functional score at six months after trauma. Secondary outcomes are pain, kyphosis angle, health related quality of life, healthcare costs and brace compliance.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no potential risks are known comparing a brace and a functional treatment. We aim that not using the TLSO results in similar functional outcome, pain and kyphosis angle, and less costs. Patients will be seen at first presentation and during two year follow up at the outpatient clinic at six standard care follow up moments. At these follow up moments a X-ray as part of standard care is made. At or just before each scheduled appointment they will fill in questionnaires taking from 15-45 minutes.
- Main changes (audit trail)
- RECORD15-mrt-2016 - 25-mei-2016


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