NCT06848660: SOFT

Study on Orthosis in Cervical Spine Fracture Treatment

Recruiting now NA Last updated 14 April 2026

What this trial tests

NA trial testing A rigid cervical collar in Cervical Spine Fractures in 616 participants. Currently enrolling.

Timeline

1 November 2025

Primary endpoint
1 June 2030

30 December 2031

Quick facts

Lead sponsor	Uppsala University Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	616
Start date	1 November 2025
Primary completion	1 June 2030
Estimated completion	30 December 2031
Sites	6 locations across Sweden

Drugs / interventions tested

• A rigid cervical collar

Conditions studied

• Cervical Spine Fractures — all drugs for Cervical Spine Fractures →
• Cervical Spine Injury — all drugs for Cervical Spine Injury →
• Rigid Collar — all drugs for Rigid Collar →

Sponsor

Uppsala University Hospital

Who can join

18 and older, any sex, with Cervical Spine Fractures or Cervical Spine Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.