Condition: Cervical Spine Fractures · Cervical Spine Injury · Rigid Collar · Sponsor: Uppsala University Hospital
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 …
This description comes directly from the study's public registry record.
Anna MacDowall M Principal investigator, Associate Professor · +46 186110000 · anna.macdowall@uu.se
Paul Gerdhem Head of Spine Department, Professor · +46186110000 · paul.gerdhem@uu.se
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| 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 |
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Source record: clinicaltrials.gov/study/NCT06848660