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Study on Orthosis in Cervical Spine Fracture Treatment

NCT06848660 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 616

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DEVICE

A rigid cervical collar

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

Sponsors & Collaborators

  • Uppsala University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2030-06-01
Completion
2031-12-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06848660 on ClinicalTrials.gov