ClinicalTrials.gov
public full text
Public Domain
Thoracolumbar Burstfractures, Orthesis or No Orthesis
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
Conceptio Open Archive
Analyze & explore related research in Conceptio
Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.
This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗
Related documents
- Brace Versus No Brace for the Treatment of Thoracolumbar Burst Fractures Without Neurologic Injury#854357
- Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures#1164753
- Effects of thoracolumbar fracture combined with muscle injury on long-term outcome and prognosis: a retrospective study.#242271
- Use of the Orthoglide for Improved Patient Outcome Following Total Knee Replacement#1140175
- Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function#1139197
Record · ID 1163091
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive