Actively Recruiting
Study on Orthosis in Cervical Spine Fracture Treatment
Led by Uppsala University Hospital · Updated on 2026-04-14
616
Participants Needed
6
Research Sites
321 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study on Orthosis in Cervical Spine Fracture Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged > 18 years with a stable cervical spine fracture.
- History of recent trauma within 3 weeks.
- Recruited within 3 weeks of injury.
- Determined by a consultant spinal surgeon as suitable for non-surgical treatment.
You will not qualify if you...
- New neurological deficit caused by the fracture.
- Additional cervical spine fracture unsuitable for non-surgical treatment.
- Underlying conditions risking spinal instability (e.g., ankylosing spondylitis, DISH, rheumatoid arthritis).
- Fracture suspected to be older than 3 weeks at assessment.
- Not expected to survive hospital discharge or surgical treatment.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Linköping University Hospital
Linköping, Sweden
Actively Recruiting
3
Skåne University Hospital
Lund, Sweden
Actively Recruiting
4
Skåne University Hospital
Malmö, Sweden
Actively Recruiting
5
Umeå University Hospital
Umeå, Sweden
Actively Recruiting
6
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
A
Anna MacDowall M Principal investigator, Associate Professor
CONTACT
P
Paul Gerdhem Head of Spine Department, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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