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The Duration of External Neck Stabilisation (DENS) Trial

NCT04895644 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-09-19

No results posted yet for this study

Summary

The Duration of External Neck Stabilisation (DENS) study is a randomised controlled trial comparing early removal of a hard collar with treatment in a hard collar for 12 weeks in older or frail adults with odontoid (dens) fractures. The primary outcome measure is QoL assessed using the EQ-5D-5L at 12 weeks following injury. The aim of the study is to determine whether management without a collar improves outcome, compared to management with a collar. Cost efficiency will be assessed over the observed 6 months using standard NICE reference case methodology.

Conditions

  • Odontoid Fracture

Interventions

OTHER

No Hard Collar

The patient in the intervention arm will not wear a Hard Collar for 12 weeks post injury

Sponsors & Collaborators

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Paul Brennan · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2024-05-31
Completion
2024-06-10

Countries

  • United Kingdom

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 NCT04895644 on ClinicalTrials.gov