Study on Orthosis in Cervical Spine Fracture Treatment

NCT06848660 | Recruiting DMC

• 1 other identifier: SOFT
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 6

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.

Conditions

Cervical Spine Fractures; Cervical Spine Injury; Rigid Collar

Keywords

cervical spine fracture treatment; cervical rigid collar; rigid collar treatment; subaxial fractures; odontoid fractures

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the 1 year of follow-up

Secondary Outcomes (5)

• European quality of life 5 dimensions 5 lite (EQ-5D 5L)

  From enrollment to 1 year of follow-up.

• European quality of life health scale (EQ-5D health)

  From enrollment to 1 year of follow-up.

• Short musculoskeletal function assessment (SMFA)

  From enrollment to 1 year of follow-up.

• Adverse events

  From enrollment to 1 year of follow-up.

• Mortality

  From enrollment to 1 year of follow-up.

Other Outcomes (3)

• Neck disability index (NDI)

  From enrollment to 1 year of follow-up.

• Compliance to rigid collar treatment

  From enrollment to 12 weeks of follow-up.

• Osteopororsis screening

  From enrollment to 12 weeks of follow-up.

Study Arms (2)

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.

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.

Interventions

A rigid cervical collar DEVICE

The rigid cervical collar is used for spinal motion restriction for 12 weeks for the non-surgical treatment of a stable cervical spine fracture.

Non-surgical treatment with a rigid collar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (6)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Skåne University Hospital

Lund, Sweden

RECRUITING

Skåne University Hospital

Malmo, Sweden

RECRUITING

Umeå University Hospital

Umeå, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Related Publications (12)

• 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.

  PMID: 35175357 BACKGROUND

• 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.

  PMID: 35840308 BACKGROUND

• 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.

  PMID: 10505521 BACKGROUND

• 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.

  PMID: 32307663 BACKGROUND

• 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.

  PMID: 30705837 BACKGROUND

• 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.

  PMID: 15568528 BACKGROUND

• 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.

  PMID: 17906580 BACKGROUND

• 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.

  PMID: 29488398 BACKGROUND

• 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.

  PMID: 21334544 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24436855 BACKGROUND

• 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.

  PMID: 8658254 BACKGROUND

Central Study Contacts

Anna MacDowall M Principal investigator, Associate Professor

CONTACT

+46 186110000; anna.macdowall@uu.se

Paul Gerdhem Head of Spine Department, Professor

CONTACT

+46186110000; paul.gerdhem@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The SOFT is a nationwide, multicenter, open label, cluster randomized crossover Register-RCT.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 27, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 30, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: The data will only be shared for the sake of study reproducibility. Upon a request stated to the principal investigator a data sharing agreement must be agreed upon and signed. The GDPR officer at Uppsala University Hospital will help setting up the data sharing agreement according to laws and regulations. Data sharing outside the European Union cannot be guaranteed at this date. After signed agreement, pseudonymized data and the R code might be securely transferred by a software with a secure 2 stage verification.

Locations

SE (6)