Thoracolumbar burst fractures, orthesis or no orthesis

Thoracolumbar burst fractures, orthesis or no orthesis - BONO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45936

Enrollment

122

Registered

2015-12-15

Start date

2016-01-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

fractured back vertebral fracture

Interventions

One group receives a Thoracolumbar Sacral Orthesis (TLSO) for 6 weeks, the other group receives no TLSO

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18-65 years Th10-L4 AO type A3 or A4 type fractures Single level Kyphosis

Exclusion criteria

Exclusion criteria: Inadequate knowledge of the Dutch language Multitrauma, which asks for multidisciplinary treatment, Injury Severity Score *16 Inability to wear a brace due to overweight (BMI> 35) Known osteoporosis

Design outcomes

Primary

Measure	Time frame
The primary outcome of this study is the functional score at six months after trauma.	—

Secondary

Measure	Time frame
Secondary outcomes are pain, kyphosis angle, health related quality of life and healthcare costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)