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

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ClinicalTrials.gov Identifier: NCT02788760
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Christina Høstmælingen, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Collar Treatment of Stable Subaxial Spine Fractures Device: Cervical collar (Miami J collar - Össur) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
6 weeks
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)
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

12 weeks
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)
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 Measures :
  1. Fracture healing [ Time Frame: 6 months ]
    The fracture healing will be assessed based on CT scans at 6 months


Secondary Outcome Measures :
  1. Pain [ Time Frame: 6 months ]
    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

  2. Level of function [ Time Frame: 6 months ]
    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

  3. Treatment failure [ Time Frame: 6 months ]
    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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788760


Contacts
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Contact: Christina T. Høstmælingen, MD +47 23027173 chhoes@ous-hf.no
Contact: Tor Brommeland, MD, PhD +47 22119573 TORBRO@ous-hf.no

Locations
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Norway
Neurosurgical department, Oslo university hospital, Ullevål Recruiting
Oslo, Norway
Contact: Christina Høstmælingen, MD    +47 23027173    chhoes@ous-hf.no   
Contact: Tor Brommeland, MD, PhD    +47 22119573    torbro@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Christina T. Høstmælingen, MD Oslo University Hospital

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Responsible Party: Christina Høstmælingen, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02788760     History of Changes
Other Study ID Numbers: 2016/332
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fractures, Bone
Spinal Fractures
Wounds and Injuries
Spinal Injuries
Back Injuries