Thoracolumbar Burstfractures, Orthesis or No Orthesis (BONO)

Elisabeth-TweeSteden Ziekenhuis

Status and phase: Unknown; Phase 4

Conditions: Spinal Fractures

Treatments: Device: Orthesis; Behavioral: No orthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT02784782

ElisabethTweeStedenZ

Details and patient eligibility

About

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.

Full description

No extra information

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Orthesis

Experimental group

Description:

Subjects 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.

Treatment:

Device: Orthesis

No Orthesis

Active Comparator group

Description:

Subjects 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.

Treatment:

Behavioral: No orthesis