Collar Treatment of Stable Subaxial Spine FracturesNCT02788760
"The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"
A study testing Cervical collar (Miami J collar - Össur) in people with Collar Treatment of Stable Subaxial Spine Fractures, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Collar Treatment of Stable Subaxial Spine Fractures
- What is being tested?
- Cervical collar (Miami J collar - Össur)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.)"
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.
Read the 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.
- Being tested
- Cervical collar (Miami J collar - Össur)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical collar (Miami J collar - Össur)Device
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
| Study group | Role | What they receive |
|---|---|---|
| 6 weeks | Other | This group of patients will be treated for 6 weeks with a cervical collar (Miami J collar - Össur) Receives: Device: Cervical collar (Miami J collar - Össur) |
| 12 weeks | Other | This group of patients will be treated for 12 weeks with a cervical collar ( (Miami J collar - Össur) Receives: Device: Cervical collar (Miami J collar - Össur) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing
The fracture healing will be assessed based on CT scans at 6 months
Measured: 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
Measured: 6 months
Secondary outcomes (2)
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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: Only 32 patients included in 21 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collar Treatment of Stable Subaxial Spine FracturesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Høstmælingen, Oslo University Hospital
- Investigators
- Christina T. Høstmælingen, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788760
- Sponsor's protocol ID
- 2016/332
- Status last verified
- Mar 2020
- First submitted
- 22 May 2016
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.)"
- ClinicalTrials.gov ID
- NCT02788760
- Acronym / sponsor ID
- 2016/332
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 32 patients included in 21 months
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6 weeks | Other | Device: Cervical collar (Miami J collar - Össur)This group of patients will be treated for 6 weeks with a cervical collar (Miami J collar - Össur) |
| 12 weeks | Other | Device: Cervical collar (Miami J collar - Össur)This group of patients will be treated for 12 weeks with a cervical collar ( (Miami J collar - Össur) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | 12 weeks, 6 weeks |
Primary outcome
Fracture healing
Time frame: 6 months
The fracture healing will be assessed based on CT scans at 6 months
Visual analogue scale - neck pain and radiculopathy
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 secondary outcomes
Level of function
Time frame: 6 months
Treatment failure
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Only 32 patients included in 21 months). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Collar Treatment of Stable Subaxial Spine Fractures
Recruiting
Study on Orthosis in Cervical Spine Fracture Treatment
Cervical Spine Fractures, Cervical Spine Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina T. Høstmælingen, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical collar (Miami J collar - Össur) in people with Collar Treatment of Stable Subaxial Spine Fractures, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only 32 patients included in 21 months). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.