Thoracolumbar Burstfractures, Orthesis or No Orthesis

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.

Conditions

• Spinal Fractures

Interventions

DEVICE

Orthesis

BEHAVIORAL

No orthesis

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Elisabeth-TweeSteden Ziekenhuis

  lead OTHER

Principal Investigators

• Taco Gosens, dr. · Elisabeth Twee Steden ziekenhuis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2018-01-31

Completion

2019-07-31

Countries

• Netherlands

Study Locations