"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"
Primary Purpose
Collar Treatment of Stable Subaxial Spine Fractures
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cervical collar (Miami J collar - Össur)
Sponsored by
About this trial
This is an interventional treatment trial for Collar Treatment of Stable Subaxial Spine Fractures
Eligibility Criteria
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
Sites / Locations
- Neurosurgical department, Oslo university hospital, Ullevål
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
6 weeks
12 weeks
Arm Description
This group of patients will be treated for 6 weeks with a cervical collar (Miami J collar - Össur)
This group of patients will be treated for 12 weeks with a cervical collar ( (Miami J collar - Össur)
Outcomes
Primary Outcome Measures
Fracture healing
The fracture healing will be assessed based on CT scans at 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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02788760
Brief Title
"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"
Official Title
"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures: Is Six Weeks as Safe as 12 Weeks? (A Randomized, Clinical Trial.)"
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Only 32 patients included in 21 months
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Collar Treatment of Stable Subaxial Spine Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6 weeks
Arm Type
Other
Arm Description
This group of patients will be treated for 6 weeks with a cervical collar (Miami J collar - Össur)
Arm Title
12 weeks
Arm Type
Other
Arm Description
This group of patients will be treated for 12 weeks with a cervical collar ( (Miami J collar - Össur)
Intervention Type
Device
Intervention Name(s)
Cervical collar (Miami J collar - Össur)
Intervention Description
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
Primary Outcome Measure Information:
Title
Fracture healing
Description
The fracture healing will be assessed based on CT scans at 6 months
Time Frame
6 months
Title
Visual analogue scale - neck pain and radiculopathy
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Level of function
Description
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
Time Frame
6 months
Title
Treatment failure
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina T. Høstmælingen, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurosurgical department, Oslo university hospital, Ullevål
City
Oslo
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"
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