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

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

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.

Study Overview

• Status: Terminated
• Conditions: Collar Treatment of Stable Subaxial Spine Fractures
• Intervention / Treatment: Device: Cervical collar (Miami J collar - Össur)

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Neurosurgical department, Oslo university hospital, Ullevål

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Christina T. Høstmælingen, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: May 22, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures
• Other Study ID Numbers: 2016/332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided