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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures: Is Six Weeks as Safe as 12 Weeks? (A Randomized, Clinical Trial.)

Conditions
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Collar Treatment of Stable Subaxial Spine Fractures

Intervention / Treatment
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* Device: Cervical collar (Miami J collar - Össur)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 6 weeks<br>This group of patients will be treated for 6 weeks with a cervical collar (Miami J collar - Össur) | Device: Cervical collar (Miami J collar - Össur)<br>* The two groups of patients will similar in every way and will be treated with the same type of cervical collar - the only difference will be the length of treatment<br>|
| Other: 12 weeks<br>This group of patients will be treated for 12 weeks with a cervical collar ( (Miami J collar - Össur) | Device: Cervical collar (Miami J collar - Össur)<br>* The two groups of patients will similar in every way and will be treated with the same type of cervical collar - the only difference will be the length of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture healing | The fracture healing will be assessed based on CT scans at 6 months | 6 months | 
| Visual analogue scale - neck pain and radiculopathy | Pain will be assessed at 6 months based on the Visual Analogue Scale and the use of pain medication will be recorded at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of function | Level of function will be assessed at 6 months using the Neck Disability Index and the Karnofsky Performance Scale Index and by registering the length of sick leave at 6 months | 6 months | 
| Treatment failure | Treatment failure will be recorded in both arms at 6 months. Defined as the need for surgery in both groups or the need to extend the use of collar from 6 to 12 weeks in the 6 weeks group | 6 months |