The Duration of External Neck Stabilisation (DENS) Trial

NCT04895644 | Completed DMC

• 1 other identifier: AC21022
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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 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

Keywords

Elderly; Hard Collar; Dens; Odontoid

Outcome Measures

Primary Outcomes (1)

• EQ-5D-5L Score - (EuroQol five dimensional descriptive system)

  Primary Outcome is Quality of Life assessed using the EQ-5D-5L questionnaire at 12 weeks post injury. EQ-5D-5L - Is the EuroQol 5D-5L a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  12 weeks

Secondary Outcomes (15)

• EQ-5D-5L Score - (EuroQol five dimensional descriptive system)

  Measured at 2 and 6 weeks and 6 months post injury

• Neck Disability Index (NDI)

  Measured at 2, 6 and 12 weeks and 6 months post injury

• Numeric Pain Rating Scale (NPRS)

  Measured at 2, 6 and 12 weeks and 6 months post injury

• Mortality

  6 months post injury

• Adverse events

  Up to 12 weeks post injury

Study Arms (2)

No Hard Collar

EXPERIMENTAL

Patient randomised to not wearing a Hard Collar for 12 weeks

Other: No Hard Collar

Standard Care Arm - Hard Collar

NO INTERVENTION

Patient randomised to wearing a Hard Collar for 12 weeks - standard care

Interventions

No Hard Collar OTHER

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

No Hard Collar

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Woodfield J, Edlmann E, Black PL, Boyd J, Copley PC, Cranswick G, Eborall H, Keerie C, Khan S, Lawton J, Lowe DJ, Norrie J, Niven A, Reed MJ, Shenkin SD, Statham P, Stoddart A, Tomlinson J, Brennan PM. Duration of External Neck Stabilisation (DENS) following odontoid fracture in older or frail adults: protocol for a randomised controlled trial of collar versus no collar. BMJ Open. 2022 Jul 15;12(7):e057753. doi: 10.1136/bmjopen-2021-057753.

  PMID: 35840308 DERIVED

Study Officials

• Paul Brennan

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: May 20, 2021
• Study Start: November 18, 2021
• Primary Completion: May 31, 2024
• Study Completion: June 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The Protocol (and consent form) has been submitted to the British Medical Journal - BMJ Open and will be available once their review is complete. The SAP will be available prior to trial completion.
• Access Criteria: Available on reasonable request to the Chief Investigator (paul.brennan@ed.ac.uk) as assessed by the study management group

Locations

GB (1)