"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"

University of Oslo (UIO)

Status: Terminated

Conditions: Collar Treatment of Stable Subaxial Spine Fractures

Treatments: Device: Cervical collar (Miami J collar - Össur)

Study type: Interventional

Funder types: Other

Identifiers

NCT02788760

2016/332

Details and patient eligibility

About

Most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. However no studies have to date been published addressing the length of treatment. There seems to be a significant dissimilarity between hospitals within and between countries with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical department at Oslo University Hospital, Ullevål the standard length of treatment for a stable cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar treatment for a specific subtype of stable fractures in the cervical spine is sufficient.

Full description

The investigators will include 150 patients with a stable cervical fractures of vertebra C3-C7 with a Subaxial Cervical Spine Injury Severity (SLIC) Score 1-3 and randomize them in to two similar groups. One group will be treated with a cervical collar for 6 weeks and the other group will be treated for 12 weeks. There will be a clinical check up and a CT scan at 1, 6, 12 and 26 weeks after the initial injury. The investigators will compare the results between the two groups when it comes to fracture healing (CT based), level of function, pain and the length of sick leave with a total of 6 months of follow up.

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a newly diagnosed (within 5 days of injury) fracture in vertebra C3-C7 with SLIC score 1-3
• Patients must be abel to give their consent to participate in the study

Exclusion criteria

• Unstable cervical fractures in need of surgery
• SLIC score >3
• Fractures of the spinous process and the transverse process in the cervical spine
• Stable fractures in in the C3-C7 vertebra combined with fractures of the C0-C2 vertebra
• Pathological fractures in the cervical spine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

6 weeks

Other group

Description:

This group of patients will be treated for 6 weeks with a cervical collar (Miami J collar - Össur)

Treatment:

Device: Cervical collar (Miami J collar - Össur)

12 weeks

Other group

Description:

This group of patients will be treated for 12 weeks with a cervical collar ( (Miami J collar - Össur)

Treatment:

Device: Cervical collar (Miami J collar - Össur)