Clinical trial NCT06848660: Study on Orthosis in Cervical Spine Fracture Treatment
Official title: Rigid Collar or No Collar for Non-surgical Treatment of Stable Cervical Spine Fractures: a Protocol for a Randomized Register Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Spine Fractures
Cervical Spine Injury
Rigid Collar
Keywords: cervical spine fracture treatment
cervical rigid collar
rigid collar treatment
subaxial fractures
odontoid fractures
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The SOFT is a nationwide, multicenter, open label, cluster randomized crossover Register-RCT.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of participants that had surgery within 1 year after the fracture incident
timeFrame: From enrollment to the 1 year of follow-up
Secondary outcomes:
measure: European quality of life 5 dimensions 5 lite (EQ-5D 5L)
timeFrame: From enrollment to 1 year of follow-up.
measure: European quality of life health scale (EQ-5D health)
timeFrame: From enrollment to 1 year of follow-up.
measure: Short musculoskeletal function assessment (SMFA)
timeFrame: From enrollment to 1 year of follow-up.
measure: Adverse events
timeFrame: From enrollment to 1 year of follow-up.
measure: Mortality
timeFrame: From enrollment to 1 year of follow-up.
Other outcomes:
measure: Neck disability index (NDI)
timeFrame: From enrollment to 1 year of follow-up.
measure: Compliance to rigid collar treatment
timeFrame: From enrollment to 12 weeks of follow-up.
measure: Osteopororsis screening
timeFrame: From enrollment to 12 weeks of follow-up.
Locations:
Study officials:
References:
citation: 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.
citation: Woodfield 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.
citation: Swiontkowski 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.
citation: Burstrom 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.
citation: Morgonskold 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.
citation: Koivikko 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.
citation: Vaccaro 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.
citation: Peck 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.
citation: Whitcroft 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.
citation: The 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.
citation: 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.
citation: Hu 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.