Efficacy of spinal orthosis in nonsurgical treatment of traumatic thoracolumbar fractures

Efficacy of spinal orthosis in nonsurgical treatment of traumatic thoracolumbar fractures - Sport-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39374

Enrollment

300

Registered

2013-02-06

Start date

2013-08-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lumbar -and throracic vertebral fractures spinal column fractures

Interventions

a spinal orthosis to wear for 12 weeks

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years and older Traumatic stable thoracolumbar fracture of the spine ( Classification of the fractures according to the AO. Type A1, A2 and A3.1 fractures considered to be stable and suitable to treat non surgical). Informed consent

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
No significant reduction of pain by wearing the orthosis, the VAS scale (0-10).	—

Secondary

Measure	Time frame
Secondary endpoints are: radiological outcome as measured by local and regional kyphosis and loss off vertebral height on plain lateral and AP X-Rays. Functional outcome as measured by Qualeffo Questionnaire and the Roland Morrison Disability Questionnaire, and their dependency on analgesics.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)