NCT06848660 Study on Orthosis in Cervical Spine Fracture Treatment
| NCT ID | NCT06848660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uppsala University Hospital |
| Condition | Cervical Spine Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 616 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2030-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 616 participants in total. It began in 2025-11-01 with a primary completion date of 2030-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06848660 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cervical Spine Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06848660 currently recruiting?
Yes, NCT06848660 is actively recruiting participants. Contact the research team at anna.macdowall@uu.se for enrollment information.
Where is the NCT06848660 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Linköping, Sweden, Lund, Sweden, Malmö, Sweden and 2 additional locations.
Who is sponsoring the NCT06848660 clinical trial?
NCT06848660 is sponsored by Uppsala University Hospital. The trial plans to enroll 616 participants.