Cervical Spine FracturesSOFTNCT06848660
Study on Orthosis in Cervical Spine Fracture Treatment
A study testing A rigid cervical collar in people with Cervical Spine Fractures and Cervical Spine Injury, run by Uppsala University Hospital at 6 sites in Sweden.
Trial summary
Background and Purpose: Neck fractures affect over 1,100 people in Sweden each year, with the majority being frail older adults. Most neck fractures are stable and therefore treated without surgery, typically using a rigid collar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spine Fractures, Cervical Spine Injury, Rigid Collar
- What is being tested?
- A rigid cervical collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 6 sitesSweden
- Study dates
- 1 Nov 2025to 30 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged > 18 years with a stable cervical spine fracture*.
- A history of recent trauma (within 3 weeks).
- Recruited within 3 weeks of injury.
- Determined by the consultant spinal surgeon as suitable for non-surgical treatment.
Who cannot join
- New neurological deficit attributable to the fracture.
- Additional cervical spine fracture not suitable for non-surgical treatment.
- Underlying condition with risk of spinal instability (e.g., ankylosing spondylitis, DISH, rheumatoid arthritis).
- Fracture suspected to be older than 3 weeks at the time of assessment.
- Not expected to survive to hospital discharge or not expected to survive surgical treatment.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna MacDowall M Principal investigator, Associate Professor contact
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
- Recruiting
Linköping University Hospital
Linköping
- Recruiting
Skåne University Hospital
Lund
- Recruiting
Skåne University Hospital
Malmö
- Recruiting
Umeå University Hospital
Umeå
- Recruiting
Uppsala University Hospital
Uppsala
About this study
Official title: Rigid Collar or no Collar for Non-surgical Treatment of Stable Cervical Spine Fractures: a Protocol for a Randomized Register Trial
Background and Purpose:
Neck fractures affect over 1,100 people in Sweden each year, with the majority being frail older adults. Most neck fractures are stable and therefore treated without surgery, typically using a rigid collar. However, the collar only limits neck movement by 40-50% and can cause pressure sores, as well as difficulties with swallowing and breathing. Because of these issues, the latest Swedish national guidelines for pre-hospital and hospital spinal motion restriction have replaced the rigid collar with other methods. This raises the question of whether the rigid collar still has a role in the modern treatment of stable neck fractures.
Read more
The aim of this study is to determine whether treatment with or without a rigid collar leads to equally good healing outcomes.
Method:
All adults diagnosed with a stable neck fracture deemed suitable for non-surgical treatment will be included in the study at the time of registration in the Swedish Fracture Register (SFR). Participating hospitals will be randomly assigned (1:1) to either use no collar at all or a rigid collar for 12 weeks. After an initial period of 1.5 years, the hospitals will switch to the opposite treatment group. A total of 616 participants are expected to be included within 3 years.
At the one-year follow-up, investigators will evaluate how many participants in each treatment group that required a switch to surgical stabilization due to treatment failure. Secondary outcomes will include quality of life, neck pain, and the need for assistive devices in relation to disability and complications in both groups.
Summary:
Non-surgical treatment rarely fails, and the need to switch from non-surgical treatment to surgery is very uncommon. The rigid collar is often prescribed out of habit, without much consideration for its potential negative effects. If this study shows that the rigid collar is unnecessary for treating stable neck fractures, frail older adults-who often struggle with collar-related discomfort, malnutrition, and pressure sores-could avoid unnecessary suffering.
Read the detailed description
The annual incidence rate of spinal fracture is 64 per 100,000 with a peak in young men and elderly women (1). Ten percent of all traumatic spinal fractures are located in the upper cervical spine and 20% in the subaxial cervical spine (2). Stable cervical spine fractures are treated non-surgically, with a rigid collar that is worn 24 hours a day for 12 weeks to limit neck movements and promote bone healing. However, rigid collars only restrict 40-50% of cervical spine motions (3, 4). The drawbacks with collar treatment are that the collar may be very uncomfortable, may cause pressure ulcer, or affect swallowing or breathing (5). Wearing a collar is associated with difficulties to perform activities of daily living due to the limited neck movement. Treatment without a collar would avoid the annoyance and potential harm, whilst the stable fracture may still heal.
Investigators aim to compare the benefit versus the harm and discomfort of rigid collar treatment with treatment without a rigid collar, in a registry based randomized controlled trial.
Treatment decisions may be made using a fracture classification such as the Subaxial injury classification and severity scale (SLICS) (6) or others. C1 and C2 fractures have separate classifications. In C1 fractures a lateral dislocation of > 7 mm is classified as unstable and requires surgical fixation. In the elderly, C2 fractures are common, secondary to low energy trauma and are mostly regarded as stable (7).
Cervical spine fractures are common enough to be a significant public health problem but too uncommon to perform a prospective study comparing the results of current treatments in a single institution. Quality registers are excellent alternatives to close these knowledge gaps. The Swedish fracture register (SFR) is a national register founded in 2011. Spinal fractures have been included since 2015, and the intra- and interrater reliability is acceptable (8). The diagnosing physician classifies the fracture with the help of drawings.
Treatment, non-surgical, or surgical treatment is registered as well as treatment failure, non-surgical treatment converted to surgical stabilization and secondary surgery after failure of the primary surgery. Patient reported outcome measures (PROMs) are sent to the participants shortly after the fracture occurrence (concerning status before the injury), and at one-year of follow-up. The PROMs include the European quality of life 5 dimensions 5 level (EQ-5D-5L) (9) and the Short Musculoskeletal Function Assessment (SMFA) (10). In SFR the treatment failure on cervical spine fractures treated non-surgically is 4% and the most common cause of failure is patients with facet joint dislocation or anterior distraction with posterior compression (manuscript in preparation). However, facet joint dislocation and anterior distraction do not often fall within the recommendations of non-surgical treatment. Investigators consider it to be safe conducting this trial. Investigators expect essentially none of the participants assigned to non-surgical treatment with or without a rigid collar to face the risk of undergoing surgical treatment.
In clinicaltrials.gov there are 3 registered trials on rigid collars; 1) The DENS trial comparing early removal versus 12 weeks treatment with a rigid collar in older frail adults with odontoid fractures (NCT04895644) (11), 2) A pilot efficacy trial comparing parathyroid hormone analog (PTH) together with a rigid collar versus historical treatment with rigid collar alone (NCT04760782), 3) A study about the length of rigid collar treatment, 6 versus 12 weeks (NCT02788760). Two randomized controlled trials (RCT) compare surgical versus non-surgical treatment of odontoid fractures in the elderly (NCT03788200, NCT02789774).
Considering the rigid collars limited effectiveness on spinal motion restriction and the potential harm they may afflict there is reason to explore the additional value of rigid collars in non-surgical treatment of stable cervical spine fractures, compared with no use of rigid collars.
- Being tested
- A rigid cervical collar
- Keywords
- cervical spine fracture treatment, cervical rigid collar, rigid collar treatment, subaxial fractures, odontoid fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A rigid cervical collarDevice
The rigid cervical collar is used for spinal motion restriction for 12 weeks for the non-surgical treatment of a stable cervical spine fracture.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical treatment with a rigid collar | Experimental | Non-surgical treatment with a rigid collar The patient will be recommended to wear a rigid collar at all times, and to be careful, for 12 weeks. The choice of supplier and brand of the cervical collar is decided by the treatment guidelines in each hospital. No planned return visits are planned for the intervention-group. The clinical routine for patients receiving non-surgical treatment is a follow-up with a fracture control including a CT scan at 10-14 days after the trauma. Physiotherapy and other rehabilitation measures will be considered and prescribed on an individual basis. Receives: Device: A rigid cervical collar |
| Non-surgical treatment without a rigid collar | No intervention | The patient will be recommended to be careful, for 12 weeks but will otherwise have no specified restrictions. The patients will follow the same clinical routine regarding a follow-up with a fracture control including a CT scan at 10-14 days after the trauma. Physiotherapy and other rehabilitation measures will be considered and prescribed on an individual basis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that had surgery within 1 year after the fracture incident
Treatment failure, defined as non- surgical treatment converted to surgical treatment, measured at 1 year of follow-up. All participants that receive cervical spine surgery within 1 year after the cervical spine fracture incident, are accounted for and compared between the groups.
Measured: From enrollment to the 1 year of follow-up
Secondary outcomes (5)
European quality of life 5 dimensions 5 lite (EQ-5D 5L)
Change from baseline to one year of follow-up, in the EQ-5D 5L index with a higher number representing better life quality, ranging from -0.59 to 1.00 (10).
Measured: From enrollment to 1 year of follow-up.
European quality of life health scale (EQ-5D health)
Change from baseline to one year of follow-up, in EQ-5D health, ranging from 0-100 with higher scores indicating better health.
Measured: From enrollment to 1 year of follow-up.
Short musculoskeletal function assessment (SMFA)
Change from baseline to one year of follow-up, in the SMFA (11), a 46-item questionnaire describing the patient´s musculoskeletal function, containing both a dysfunction index and a bother index. The indexes range from 0-100.
Measured: From enrollment to 1 year of follow-up.
Adverse events
Adverse events might be pressure ulcer, difficulty in swallowing or breathing or other uncomfortable experiences. Prolonged neck pain and fracture pseudarthrosis is an adverse event as long as no surgical treatment has been performed to resolve the neck pain or fracture pseudarthrosis.
Measured: From enrollment to 1 year of follow-up.
Mortality
The participant has deceased.
Measured: From enrollment to 1 year of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Nov 2025
- Primary completion1 Jun 2030 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cervical Spine FracturesStudies of the same condition, open and under way.
- 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
- Model description
- The SOFT is a nationwide, multicenter, open label, cluster randomized crossover Register-RCT.
- Masking
- None (open label)
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Mac Dowall, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848660
- Sponsor's protocol ID
- SOFT
- Acronym
- SOFT
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data and the R code used for statistical analysis may be shared upon request after the final publication of the results of the study.
Publications
Blixt S, Mukka S, Forsth P, Westin O, Gerdhem P; SunBurst study group. Study protocol: The SunBurst trial-a register-based, randomized controlled trial on thoracolumbar burst fractures. Acta Orthop. 2022 Jan 24;93:256-263. doi: 10.2340/17453674.2022.1614.
PubMed 35175357Woodfield J, Edlmann E, Black PL, Boyd J, Copley PC, Cranswick G, Eborall H, Keerie C, Khan S, Lawton J, Lowe DJ, Norrie J, Niven A, Reed MJ, Shenkin SD, Statham P, Stoddart A, Tomlinson J, Brennan PM. Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar. BMJ Open. 2022 Jul 15;12(7):e057753. doi: 10.1136/bmjopen-2021-057753.
PubMed 35840308Swiontkowski MF, Engelberg R, Martin DP, Agel J. Short musculoskeletal function assessment questionnaire: validity, reliability, and responsiveness. J Bone Joint Surg Am. 1999 Sep;81(9):1245-60. doi: 10.2106/00004623-199909000-00006.
PubMed 10505521Burstrom K, Teni FS, Gerdtham UG, Leidl R, Helgesson G, Rolfson O, Henriksson M. Experience-Based Swedish TTO and VAS Value Sets for EQ-5D-5L Health States. Pharmacoeconomics. 2020 Aug;38(8):839-856. doi: 10.1007/s40273-020-00905-7.
PubMed 32307663Morgonskold D, Warkander V, Savvides P, Wihlborg A, Bouzereau M, Moller H, Gerdhem P. Inter- and intra-rater reliability of vertebral fracture classifications in the Swedish fracture register. World J Orthop. 2019 Jan 18;10(1):14-22. doi: 10.5312/wjo.v10.i1.14. eCollection 2019 Jan 18.
PubMed 30705837Koivikko MP, Kiuru MJ, Koskinen SK, Myllynen P, Santavirta S, Kivisaari L. Factors associated with nonunion in conservatively-treated type-II fractures of the odontoid process. J Bone Joint Surg Br. 2004 Nov;86(8):1146-51. doi: 10.1302/0301-620x.86b8.14839.
PubMed 15568528Vaccaro AR, Hulbert RJ, Patel AA, Fisher C, Dvorak M, Lehman RA Jr, Anderson P, Harrop J, Oner FC, Arnold P, Fehlings M, Hedlund R, Madrazo I, Rechtine G, Aarabi B, Shainline M; Spine Trauma Study Group. The subaxial cervical spine injury classification system: a novel approach to recognize the importance of morphology, neurology, and integrity of the disco-ligamentous complex. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2365-74. doi: 10.1097/BRS.0b013e3181557b92.
PubMed 17906580Peck GE, Shipway DJH, Tsang K, Fertleman M. Cervical spine immobilisation in the elderly: a literature review. Br J Neurosurg. 2018 Jun;32(3):286-290. doi: 10.1080/02688697.2018.1445828. Epub 2018 Feb 28.
PubMed 29488398Whitcroft KL, Massouh L, Amirfeyz R, Bannister GC. A comparison of neck movement in the soft cervical collar and rigid cervical brace in healthy subjects. J Manipulative Physiol Ther. 2011 Feb;34(2):119-22. doi: 10.1016/j.jmpt.2010.12.007.
PubMed 21334544The Effectiveness of Four Contemporary Cervical Orthoses in Restricting Cervical Motion Lunsford, Thomas R. MSE, CO; Davidson, Michael; Lunsford, Brenda R. MAPT, MS Author Information JPO Journal of Prosthetics and Orthotics 6(4):p 93-99, Fall 1994.
Tee JW, Chan CH, Fitzgerald MC, Liew SM, Rosenfeld JV. Epidemiological trends of spine trauma: an Australian level 1 trauma centre study. Global Spine J. 2013 Jun;3(2):75-84. doi: 10.1055/s-0033-1337124. Epub 2013 Mar 19.
PubMed 24436855Hu R, Mustard CA, Burns C. Epidemiology of incident spinal fracture in a complete population. Spine (Phila Pa 1976). 1996 Feb 15;21(4):492-9. doi: 10.1097/00007632-199602150-00016.
PubMed 8658254
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rigid Collar or no Collar for Non-surgical Treatment of Stable Cervical Spine Fractures: a Protocol for a Randomized Register Trial
- ClinicalTrials.gov ID
- NCT06848660
- Acronym / sponsor ID
- SOFT / SOFT
- Keywords
- cervical spine fracture treatment, cervical rigid collar, rigid collar treatment, subaxial fractures, odontoid fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 27 Feb 2025 (actual)
- 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.
Background and Purpose:
Neck fractures affect over 1,100 people in Sweden each year, with the majority being frail older adults. Most neck fractures are stable and therefore treated without surgery, typically using a rigid collar. However, the collar only limits neck movement by 40-50% and can cause pressure sores, as well as difficulties with swallowing and breathing. Because of these issues, the latest Swedish national guidelines for pre-hospital and hospital spinal motion restriction have replaced the rigid collar with other methods. This raises the question of whether the rigid collar still has a role in the modern treatment of stable neck fractures.
The aim of this study is to determine whether treatment with or without a rigid collar leads to equally good healing outcomes.
Method:
All adults diagnosed with a stable neck fracture deemed suitable for non-surgical treatment will be included in the study at the time of registration in the Swedish Fracture Register (SFR). Participating hospitals will be randomly assigned (1:1) to either use no collar at all or a rigid collar for 12 weeks. After an initial period of 1.5 years, the hospitals will switch to the opposite treatment group. A total of 616 participants are expected to be included within 3 years.
At the one-year follow-up, investigators will evaluate how many participants in each treatment group that required a switch to surgical stabilization due to treatment failure. Secondary outcomes will include quality of life, neck pain, and the need for assistive devices in relation to disability and complications in both groups.
Summary:
Non-surgical treatment rarely fails, and the need to switch from non-surgical treatment to surgery is very uncommon. The rigid collar is often prescribed out of habit, without much consideration for its potential negative effects. If this study shows that the rigid collar is unnecessary for treating stable neck fractures, frail older adults-who often struggle with collar-related discomfort, malnutrition, and pressure sores-could avoid unnecessary suffering.
Detailed description
The annual incidence rate of spinal fracture is 64 per 100,000 with a peak in young men and elderly women (1). Ten percent of all traumatic spinal fractures are located in the upper cervical spine and 20% in the subaxial cervical spine (2). Stable cervical spine fractures are treated non-surgically, with a rigid collar that is worn 24 hours a day for 12 weeks to limit neck movements and promote bone healing. However, rigid collars only restrict 40-50% of cervical spine motions (3, 4). The drawbacks with collar treatment are that the collar may be very uncomfortable, may cause pressure ulcer, or affect swallowing or breathing (5). Wearing a collar is associated with difficulties to perform activities of daily living due to the limited neck movement. Treatment without a collar would avoid the annoyance and potential harm, whilst the stable fracture may still heal.
Investigators aim to compare the benefit versus the harm and discomfort of rigid collar treatment with treatment without a rigid collar, in a registry based randomized controlled trial.
Treatment decisions may be made using a fracture classification such as the Subaxial injury classification and severity scale (SLICS) (6) or others. C1 and C2 fractures have separate classifications. In C1 fractures a lateral dislocation of > 7 mm is classified as unstable and requires surgical fixation. In the elderly, C2 fractures are common, secondary to low energy trauma and are mostly regarded as stable (7).
Cervical spine fractures are common enough to be a significant public health problem but too uncommon to perform a prospective study comparing the results of current treatments in a single institution. Quality registers are excellent alternatives to close these knowledge gaps. The Swedish fracture register (SFR) is a national register founded in 2011. Spinal fractures have been included since 2015, and the intra- and interrater reliability is acceptable (8). The diagnosing physician classifies the fracture with the help of drawings.
Treatment, non-surgical, or surgical treatment is registered as well as treatment failure, non-surgical treatment converted to surgical stabilization and secondary surgery after failure of the primary surgery. Patient reported outcome measures (PROMs) are sent to the participants shortly after the fracture occurrence (concerning status before the injury), and at one-year of follow-up. The PROMs include the European quality of life 5 dimensions 5 level (EQ-5D-5L) (9) and the Short Musculoskeletal Function Assessment (SMFA) (10). In SFR the treatment failure on cervical spine fractures treated non-surgically is 4% and the most common cause of failure is patients with facet joint dislocation or anterior distraction with posterior compression (manuscript in preparation). However, facet joint dislocation and anterior distraction do not often fall within the recommendations of non-surgical treatment. Investigators consider it to be safe conducting this trial. Investigators expect essentially none of the participants assigned to non-surgical treatment with or without a rigid collar to face the risk of undergoing surgical treatment.
In clinicaltrials.gov there are 3 registered trials on rigid collars; 1) The DENS trial comparing early removal versus 12 weeks treatment with a rigid collar in older frail adults with odontoid fractures (NCT04895644) (11), 2) A pilot efficacy trial comparing parathyroid hormone analog (PTH) together with a rigid collar versus historical treatment with rigid collar alone (NCT04760782), 3) A study about the length of rigid collar treatment, 6 versus 12 weeks (NCT02788760). Two randomized controlled trials (RCT) compare surgical versus non-surgical treatment of odontoid fractures in the elderly (NCT03788200, NCT02789774).
Considering the rigid collars limited effectiveness on spinal motion restriction and the potential harm they may afflict there is reason to explore the additional value of rigid collars in non-surgical treatment of stable cervical spine fractures, compared with no use of rigid collars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The SOFT is a nationwide, multicenter, open label, cluster randomized crossover Register-RCT.
| Arm | Type | Receives |
|---|---|---|
| Non-surgical treatment with a rigid collar | Experimental | Device: A rigid cervical collarNon-surgical treatment with a rigid collar The patient will be recommended to wear a rigid collar at all times, and to be careful, for 12 weeks. The choice of supplier and brand of the cervical collar is decided by the treatment guidelines in each hospital. No planned return visits are planned for the intervention-group. The clinical routine for patients receiving non-surgical treatment is a follow-up with a fracture control including a CT scan at 10-14 days after the trauma. Physiotherapy and other rehabilitation measures will be considered and prescribed on an individual basis. |
| Non-surgical treatment without a rigid collar | No intervention | –The patient will be recommended to be careful, for 12 weeks but will otherwise have no specified restrictions. The patients will follow the same clinical routine regarding a follow-up with a fracture control including a CT scan at 10-14 days after the trauma. Physiotherapy and other rehabilitation measures will be considered and prescribed on an individual basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged > 18 years with a stable cervical spine fracture*.
- A history of recent trauma (within 3 weeks).
- Recruited within 3 weeks of injury.
- Determined by the consultant spinal surgeon as suitable for non-surgical treatment.
Key exclusion criteria (5 listed)
- New neurological deficit attributable to the fracture.
- Additional cervical spine fracture not suitable for non-surgical treatment.
- Underlying condition with risk of spinal instability (e.g., ankylosing spondylitis, DISH, rheumatoid arthritis).
- Fracture suspected to be older than 3 weeks at the time of assessment.
- Not expected to survive to hospital discharge or not expected to survive surgical treatment.
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 |
|---|---|---|
| A rigid cervical collarThe rigid cervical collar is used for spinal motion restriction for 12 weeks for the non-surgical treatment of a stable cervical spine fracture. | Device | Non-surgical treatment with a rigid collar |
Primary outcome
Number of participants that had surgery within 1 year after the fracture incident
Time frame: From enrollment to the 1 year of follow-up
Treatment failure, defined as non- surgical treatment converted to surgical treatment, measured at 1 year of follow-up. All participants that receive cervical spine surgery within 1 year after the cervical spine fracture incident, are accounted for and compared between the groups.
5 secondary outcomes
European quality of life 5 dimensions 5 lite (EQ-5D 5L)
Time frame: From enrollment to 1 year of follow-up.
European quality of life health scale (EQ-5D health)
Time frame: From enrollment to 1 year of follow-up.
Short musculoskeletal function assessment (SMFA)
Time frame: From enrollment to 1 year of follow-up.
Adverse events
Time frame: From enrollment to 1 year of follow-up.
Mortality
Time frame: From enrollment to 1 year of follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 35175357Blixt S, Mukka S, Forsth P, Westin O, Gerdhem P; SunBurst study group. Study protocol: The SunBurst trial-a register-based, randomized controlled trial on thoracolumbar burst fractures. Acta Orthop. 2022 Jan 24;93:256-263. doi: 10.2340/17453674.2022.1614.
- Background: PubMed 35840308Woodfield J, Edlmann E, Black PL, Boyd J, Copley PC, Cranswick G, Eborall H, Keerie C, Khan S, Lawton J, Lowe DJ, Norrie J, Niven A, Reed MJ, Shenkin SD, Statham P, Stoddart A, Tomlinson J, Brennan PM. Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar. BMJ Open. 2022 Jul 15;12(7):e057753. doi: 10.1136/bmjopen-2021-057753.
- Background: PubMed 10505521Swiontkowski MF, Engelberg R, Martin DP, Agel J. Short musculoskeletal function assessment questionnaire: validity, reliability, and responsiveness. J Bone Joint Surg Am. 1999 Sep;81(9):1245-60. doi: 10.2106/00004623-199909000-00006.
- Background: PubMed 32307663Burstrom K, Teni FS, Gerdtham UG, Leidl R, Helgesson G, Rolfson O, Henriksson M. Experience-Based Swedish TTO and VAS Value Sets for EQ-5D-5L Health States. Pharmacoeconomics. 2020 Aug;38(8):839-856. doi: 10.1007/s40273-020-00905-7.
- Background: PubMed 30705837Morgonskold D, Warkander V, Savvides P, Wihlborg A, Bouzereau M, Moller H, Gerdhem P. Inter- and intra-rater reliability of vertebral fracture classifications in the Swedish fracture register. World J Orthop. 2019 Jan 18;10(1):14-22. doi: 10.5312/wjo.v10.i1.14. eCollection 2019 Jan 18.
- Background: PubMed 15568528Koivikko MP, Kiuru MJ, Koskinen SK, Myllynen P, Santavirta S, Kivisaari L. Factors associated with nonunion in conservatively-treated type-II fractures of the odontoid process. J Bone Joint Surg Br. 2004 Nov;86(8):1146-51. doi: 10.1302/0301-620x.86b8.14839.
- Background: PubMed 17906580Vaccaro AR, Hulbert RJ, Patel AA, Fisher C, Dvorak M, Lehman RA Jr, Anderson P, Harrop J, Oner FC, Arnold P, Fehlings M, Hedlund R, Madrazo I, Rechtine G, Aarabi B, Shainline M; Spine Trauma Study Group. The subaxial cervical spine injury classification system: a novel approach to recognize the importance of morphology, neurology, and integrity of the disco-ligamentous complex. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2365-74. doi: 10.1097/BRS.0b013e3181557b92.
- Background: PubMed 29488398Peck GE, Shipway DJH, Tsang K, Fertleman M. Cervical spine immobilisation in the elderly: a literature review. Br J Neurosurg. 2018 Jun;32(3):286-290. doi: 10.1080/02688697.2018.1445828. Epub 2018 Feb 28.
- Background: PubMed 21334544Whitcroft KL, Massouh L, Amirfeyz R, Bannister GC. A comparison of neck movement in the soft cervical collar and rigid cervical brace in healthy subjects. J Manipulative Physiol Ther. 2011 Feb;34(2):119-22. doi: 10.1016/j.jmpt.2010.12.007.
- BackgroundThe Effectiveness of Four Contemporary Cervical Orthoses in Restricting Cervical Motion Lunsford, Thomas R. MSE, CO; Davidson, Michael; Lunsford, Brenda R. MAPT, MS Author Information JPO Journal of Prosthetics and Orthotics 6(4):p 93-99, Fall 1994.
- Background: PubMed 24436855Tee JW, Chan CH, Fitzgerald MC, Liew SM, Rosenfeld JV. Epidemiological trends of spine trauma: an Australian level 1 trauma centre study. Global Spine J. 2013 Jun;3(2):75-84. doi: 10.1055/s-0033-1337124. Epub 2013 Mar 19.
- Background: PubMed 8658254Hu R, Mustard CA, Burns C. Epidemiology of incident spinal fracture in a complete population. Spine (Phila Pa 1976). 1996 Feb 15;21(4):492-9. doi: 10.1097/00007632-199602150-00016.
- Individual participant dataSharing planned: Yes. Pseudonymized data and the R code used for statistical analysis may be shared upon request after the final publication of the results of the study.
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Spine Fracture, Degenerative Disc Disease
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.
Anna MacDowall M Principal investigator, Associate Professor contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A rigid cervical collar in people with Cervical Spine Fractures and Cervical Spine Injury, run by Uppsala University Hospital at 6 sites in Sweden.
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 4 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna MacDowall M Principal investigator, Associate Professor (+46 186110000, anna.macdowall@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that had surgery within 1 year after the fracture incident (time frame: From enrollment to the 1 year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06848660, which also lists 12 linked publications.
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 14 Apr 2026.