Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT02788760
Status:
TERMINATED
Last Update Posted:
2020-03-09
First Post:
2016-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"
Sponsor:
Oslo University Hospital
Organization:
Study Overview
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.)"
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only 32 patients included in 21 months
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: