Status:
COMPLETED
The Duration of External Neck Stabilisation (DENS) Trial
Lead Sponsor:
University of Edinburgh
Conditions:
Odontoid Fracture
Eligibility:
All Genders
Phase:
NA
Brief 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...
Detailed Description
This is a non-blinded randomised controlled trial with nested qualitative research comparing early removal of a hard collar (intervention) with treatment in a hard collar for 12 weeks (standard care) ...
Eligibility Criteria
Inclusion
- Rockwood clinical frailty scale (CFS) of 5 or more, or aged 65 years or over;
- A recent odontoid fracture (type I-III) (within 3 weeks) as assessed on CT, irrespective of degree of fracture angulation, displacement or canal narrowing;
- History of recent trauma (within 3 weeks)
- Determined by spinal consultant (or delegated registrar) as suitable for standard care 12-week treatment with hard collar and for randomisation to treatment without a collar
- Recruited within 3 weeks of injury
Exclusion
- New neurological deficit (numbness / weakness) attributable to fracture;
- Assessed as unable to tolerate a hard collar e.g., dystonia, fixed deformity;
- Additional (non-odontoid) cervical spine fracture not suitable for management without a hard collar;
- Underlying condition potentially leading to spinal instability, e.g., ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis (DISH);
- Fracture suspected to be older than three weeks at the time of assessment;
- Consultant spinal surgeon determines fracture requires surgical treatment or is otherwise unsuitable for non-surgical treatment with or without a hard collar;
- If not expected to survive to hospital discharge based on concomitant injuries or illnesses.
Key Trial Info
Start Date :
November 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04895644
Start Date
November 18 2021
End Date
June 10 2024
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA