Thoracolumbar Burstfractures, Orthesis or No Orthesis
BONO
1 other identifier
interventional
122
1 country
1
Brief Summary
Rationale: 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: The investigators 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. The investigators hypothesize that no treatment is superior over one other. Study design: This project is a randomised controlled trial comparing brace and no brace treatment on function, kyphosis angle, pain, quality of life, and costs. Study population: 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. Literature shows no difference in pain, functional outcome or kyphosis angle, therefore no potential risks are known comparing a brace and a functional treatment. Investigators 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 15, 2016
CompletedFirst Posted
Study publicly available on registry
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedMay 27, 2016
May 1, 2016
1.8 years
March 15, 2016
May 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional score
Oswestry Disability Index (ODI) derived from the Oswestry Low Back Pain Questionnaire used to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
at six months, measured up to two years
Secondary Outcomes (7)
Quality of life score
up to two years
Patient reported health status
up to two years
Quality of life score
up to two years
Pain
up to two years
Medical Consumption
up to two years
- +2 more secondary outcomes
Other Outcomes (1)
Length of hospital stay
From first admission until discharge from the hospital up to 10 weeks
Study Arms (2)
Orthesis
EXPERIMENTALSubjects will wear a TLSO for 6 weeks 24 hours a day or they will not. 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 Intervention: After fitting the patient starts mobilising, under supervision of a physiotherapist, until pain is under control with oral analgesia. Sports and heavy lifting are prohibited for 3 months. No physiotherapy treatment is needed. During two year follow up patients will be seen at the outpatient clinic during standard care follow up moments. At or just before each scheduled appointment they will fill in questionnaires. These questionnaires will take 15-45 minutes.
No Orthesis
ACTIVE COMPARATORSubjects will wear a TLSO for 6 weeks 24 hours a day or they will not. 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. Control: The patient starts mobilising, under supervision of a physiotherapist, until pain is under control with oral analgesia. Sports and heavy lifting are prohibited for 3 months. No physiotherapy treatment is needed. During two year follow up patients will be seen at the outpatient clinic during standard care follow up moments. At or just before each scheduled appointment they will fill in questionnaires. These questionnaires will take 15-45 minutes.
Interventions
Eligibility Criteria
You may qualify if:
- Th10-L4
- AO foundation type A3 or A4 type fractures
- Single level
- Kyphosis \< 35 ° at first analysis
- Neurologically intact
- Adequate trauma
You may not qualify if:
- Inadequate knowledge of the Dutch language
- Multitrauma, which asks for multidisciplinary treatment
- Inability to wear a brace due to overweight (BMI\> 35)
- Known osteoporosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Elisabeth Twee Steden ziekenhuis
Tilburg, 5000LC, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taco Gosens, dr.
Elisabeth Twee Steden ziekenhuis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- drs.
Study Record Dates
First Submitted
March 15, 2016
First Posted
May 27, 2016
Study Start
March 1, 2016
Primary Completion
January 1, 2018
Study Completion
July 1, 2019
Last Updated
May 27, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will share
In this research project the investigators aim for multiple publications in scientific journals and a promotion of a PhD student. The investigators want to develop a treating protocol with better functional outcome and less costs.