Clinical trial NCT02784782: Thoracolumbar Burstfractures, Orthesis or No Orthesis
Official title: Thoracolumbar Burstfractures, Orthesis or no Orthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Fractures
Keywords: Spinal
Vertebral
Burstfracture
Orthesis
Brace
Thoracolumbar
Lead sponsor: Elisabeth-TweeSteden Ziekenhuis
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2016-05-27
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: No extra information

Eligibility criteria: Inclusion Criteria:

* Th10-L4
* AO foundation 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

Primary outcomes:
measure: Functional score
timeFrame: at six months, measured up to two years
Secondary outcomes:
measure: Quality of life score
timeFrame: up to two years
measure: Patient reported health status
timeFrame: up to two years
measure: Quality of life score
timeFrame: up to two years
measure: Pain
timeFrame: up to two years
measure: Medical Consumption
timeFrame: up to two years
measure: Productivity costs
timeFrame: up to two years
measure: Work Ability
timeFrame: up to two years
Other outcomes:
measure: Length of hospital stay
timeFrame: From first admission until discharge from the hospital up to 10 weeks
Locations:
city: Tilburg
country: Netherlands
facility: Elisabeth Twee Steden ziekenhuis
Study officials:
affiliation: Elisabeth Twee Steden ziekenhuis
name: Taco Gosens, dr.
role: PRINCIPAL_INVESTIGATOR
References: