Rigid neck collar versus no collar for healing stable neck (cervical) fractures
Rigid Collar or no Collar for Non-surgical Treatment of Stable Cervical Spine Fractures: a Protocol for a Randomized Register Trial
This will test whether adults with stable neck fractures heal just as well without a rigid neck collar as they do with one.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 616 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Hospital Academic / other |
| Locations | 6 sites (Gothenburg and 5 other locations) |
| Trial ID | NCT06848660 on ClinicalTrials.gov |
What this trial studies
This is a registry-based randomized controlled trial enrolling adults with recent, stable cervical spine fractures who are judged suitable for non-surgical management. Participants randomized to either wear a rigid cervical collar (typically 24 hours/day for up to 12 weeks) or to receive no rigid collar, with follow-up to compare bone healing, comfort, and complications. The trial uses the Swedish Fracture Register for recruitment and outcome tracking and applies standard fracture classification systems to guide eligibility. Key outcomes include radiographic healing, development of pressure ulcers or swallowing/breathing problems, and patient-reported function.
Who should consider this trial
Good fit: Adults over 18 with a recent (within 3 weeks) stable cervical spine fracture judged suitable for non-surgical treatment by a consultant spinal surgeon are ideal candidates.
Not a fit: Patients with unstable fractures, new neurological deficits, additional cervical injuries requiring surgery, or underlying conditions that risk spinal instability (e.g., ankylosing spondylitis) are unlikely to benefit.
Why it matters
Potential benefit: If successful, patients could avoid the discomfort and complications of a rigid collar without worsening fracture healing.
How similar studies have performed: Randomized data directly comparing routine rigid collar use to no collar are limited, so this registry-based randomized approach addresses an important and relatively untested question despite prior guideline shifts away from collars.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gothenburg and 5 other locations
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Skåne University Hospital — Lund, Sweden (Recruiting)
- Skåne University Hospital — Malmö, Sweden (Recruiting)
- Umeå University Hospital — Umeå, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Anna MacDowall M Principal investigator, Associate Professor
- Email: anna.macdowall@uu.se
- Phone: +46 186110000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.