Odontoid FractureDENSNCT04895644
The Duration of External Neck Stabilisation (DENS) Trial
A study testing No Hard Collar in people with Odontoid Fracture, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Odontoid Fracture
- What is being tested?
- No Hard Collar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2021to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration Of External Neck Stabilisation Following Odontoid Fracture In Older Or Frail Adults: A Randomised Controlled Trial Of Early Versus Late Collar Removal
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.
Read the 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) in older or frail adults with odontoid peg fractures. The primary outcome measure is QoL assessed using the EQ-5D-5L at 12 weeks following randomisation.
Potentially eligible participants will be assessed in the ED, or on hospital admission. Assessment of eligibility, recruitment and randomisation should take place as soon as possible (target within 48 hours) after injury. Patients with incapacity who are unable to give informed consent may still be recruited.
Exceptionally, patients who have not been assessed for eligibility at the time of their acute admission, or who were assessed but in whom there was some other delay to study inclusion, may be recruited up to 3 weeks post-injury.
Those who take part will be randomised to continuing in a hard collar for 12 weeks or to early removal of the hard collar.
During the pilot phase, a subset of patients, caregivers and health professionals will be interviewed.
In current standard care, patients with suspected cervical spine injuries are usually (but not universally) immobilised with non-padded trauma collars or blocks, possibly on spinal boards, on admission to the ED. Early removal of this emergency immobilisation and replacement with a padded hard collar (e.g. Miami J, Aspen, Philadelphia) as per standard care is desirable for skin care and comfort. In this study this immobilisation replacement will take place as usual with guidance from ED and spinal service (orthopaedic/ neurosurgical), on-call staff, according to local protocols. This avoids any delay in removal of emergency immobilisation that might be caused by trial procedures to establish eligibility or consent that could lead to poorer quality of care for participants.
All participants will undergo standard care investigations for suspected cervical spine fracture. This includes CT of the cervical spine to identify fractures, and a full neurological examination and assessment. All participants will be discussed with the on-call spinal (neurosurgical/orthopaedic) service unit as per usual protocols. All participants will be given adequate analgesia for neck pain. Participants will only be enrolled following a consultant radiologist report of an odontoid fracture and confirmation from the local spinal consultant that randomisation to non-operative management with or without a hard collar is appropriate.
- Conditions
- Odontoid Fracture
- Being tested
- No Hard Collar
- Keywords
- Elderly, Hard Collar, Dens, Odontoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Hard CollarOther
The patient in the intervention arm will not wear a Hard Collar for 12 weeks post injury
| Study group | Role | What they receive |
|---|---|---|
| No Hard Collar | Experimental | Patient randomised to not wearing a Hard Collar for 12 weeks Receives: Other: No Hard Collar |
| Standard Care Arm - Hard Collar | No intervention | Patient randomised to wearing a Hard Collar for 12 weeks - standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (15)
EQ-5D-5L Score - (EuroQol five dimensional descriptive system)
Secondary outcome is Quality of Life assessed using the EQ-5D-5L questionnaire at 2 and 6 weeks and 6 months 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.
Measured: Measured at 2 and 6 weeks and 6 months post injury
Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's neck pain related disability. Each question is measured on a scale from 0 (no disability) to 5, and an overall score out of 50 is calculated by adding each item score together. This score is then multiplied by two to give a percentage score. A higher NDI score means the greater a patient's perceived disability due to neck pain.
Measured: Measured at 2, 6 and 12 weeks and 6 months post injury
Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale is used to measure the patient's perception of their neck pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst pain imaginable. This data can be collected on paper or over the phone.
Measured: Measured at 2, 6 and 12 weeks and 6 months post injury
Mortality
Mortality
Measured: 6 months post injury
Adverse events
Adverse events
Measured: Up to 12 weeks post injury
Fracture site bony fusion
In fracture site bony fusion at approximately 12 weeks assessed on imaging (CT, flexion-extension x-rays or MRI) where performed as part of standard care
Measured: 12 weeks post injury
Fracture site stability
In fracture site stability at approximately 12 weeks assessed on imaging (CT, flexion-extension x-rays or MRI) where performed as part of standard care
Measured: 12 weeks post injury
Loss of muscle bulk in upper limbs - assessed using a combination of grip strength and muscle bio-impedance
Loss of muscle bulk in upper limbs will be assessed using grip strength and muscle bio-impedance.
In consenting participants, hand grip strength will be measured using a dynamometer. Participants will be seated, their elbow by their side and flexed to right angles, and a neutral wrist position. The mean of three trials of grip strength will be reported for each hand.
Bioelectric impedance (Bio-impedance) analysis measurements will be made at the right wrist and ankle, with the subject supine. Muscle mass is calculated according to Janseen et al.
skeletal muscle mass (kg) =[height2/Bioimepedance x 0.401) +(gender x 3.825) +(age x -0.071)] +5.102
where height is in centimetres, Bio-impedance in ohms, gender male =1 and female=0, and age is in years. The skeletal muscle index in kg/m2 is obtained by dividing the muscle mass by squared height.
Measured: Measured over 12 weeks
Late injury-related complications
Late injury-related complications, such as new neurological deficit
Measured: Up to 6 months post injury
Total number of hospital admissions or outpatient visits
In patient hospitalisations including outpatient visits and total inpatient bed days
Measured: Up to 6 months post injury
Total amount of health and social care visits/use
Health care, community health and social care use and primary care visits
Measured: Up to 6 months post injury
Compliance with Hard Collar Use
Compliance with Hard Collar wear in a sample of patients. iButtons or similar will be placed inside the hard collar of a small sample of patients. These buttons record variations in temperature and can therefore measure compliance with collar wear.
Measured: Up to 12 weeks post injury
Length of primary admission
Length of primary admission
Measured: The total length of time between a patient's primary admission and their discharge from hospital. Up to 12 weeks after admission.
Discharge destination
The location the patient will be discharged to eg. home, care home
Measured: Noted at point of discharge of participant. Usually within 12 weeks after admission.
Health Economics Analysis
A 6 month within trial analysis will be undertaken based on National Institute for Health and Care Excellence (NICE) reference case recommendations to maximise UK policy relevance. This will include: Adoption of an National Health Service (NHS) and Personal Social Services (PSS) decision perspective; cost-utility approach for primary analysis (results presented in terms of incremental cost per quality adjusted life year (QALY) derived from EQ-5D-5L data with an area under the curve approach, omitting baseline); discount rate of 3.5% for both costs and QALYs (where applicable); and use of probabilistic sensitivity analysis (PSA), to generate cost effectiveness acceptability curves (CEACs). Choice of primary analysis cost per QALY threshold and EQ-5D-5L scoring algorithm will be selected to match NICE preferences. NHS \& PSS resource use will be extracted from medical records with some top-up self-report surveying. These will be combined with standard UK price weights to generate costs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start18 Nov 2021
- Primary completion31 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Odontoid FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Brennan, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895644
- Sponsor's protocol ID
- AC21022
- Acronym
- DENS
- Status last verified
- Sep 2024
- First submitted
- 31 Mar 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised patient-level data will be available on reasonable request to the Chief Investigator (paul.brennan@ed.ac.uk). The trial protocol and statistical analysis plans will be published and available prior to trial completion.
Publications
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.
PubMed 35840308
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration Of External Neck Stabilisation Following Odontoid Fracture In Older Or Frail Adults: A Randomised Controlled Trial Of Early Versus Late Collar Removal
- ClinicalTrials.gov ID
- NCT04895644
- Acronym / sponsor ID
- DENS / AC21022
- Conditions
- Odontoid Fracture
- Keywords
- Elderly, Hard Collar, Dens, Odontoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) in older or frail adults with odontoid peg fractures. The primary outcome measure is QoL assessed using the EQ-5D-5L at 12 weeks following randomisation.
Potentially eligible participants will be assessed in the ED, or on hospital admission. Assessment of eligibility, recruitment and randomisation should take place as soon as possible (target within 48 hours) after injury. Patients with incapacity who are unable to give informed consent may still be recruited.
Exceptionally, patients who have not been assessed for eligibility at the time of their acute admission, or who were assessed but in whom there was some other delay to study inclusion, may be recruited up to 3 weeks post-injury.
Those who take part will be randomised to continuing in a hard collar for 12 weeks or to early removal of the hard collar.
During the pilot phase, a subset of patients, caregivers and health professionals will be interviewed.
In current standard care, patients with suspected cervical spine injuries are usually (but not universally) immobilised with non-padded trauma collars or blocks, possibly on spinal boards, on admission to the ED. Early removal of this emergency immobilisation and replacement with a padded hard collar (e.g. Miami J, Aspen, Philadelphia) as per standard care is desirable for skin care and comfort. In this study this immobilisation replacement will take place as usual with guidance from ED and spinal service (orthopaedic/ neurosurgical), on-call staff, according to local protocols. This avoids any delay in removal of emergency immobilisation that might be caused by trial procedures to establish eligibility or consent that could lead to poorer quality of care for participants.
All participants will undergo standard care investigations for suspected cervical spine fracture. This includes CT of the cervical spine to identify fractures, and a full neurological examination and assessment. All participants will be discussed with the on-call spinal (neurosurgical/orthopaedic) service unit as per usual protocols. All participants will be given adequate analgesia for neck pain. Participants will only be enrolled following a consultant radiologist report of an odontoid fracture and confirmation from the local spinal consultant that randomisation to non-operative management with or without a hard collar is appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| No Hard Collar | Experimental | Other: No Hard CollarPatient randomised to not wearing a Hard Collar for 12 weeks |
| Standard Care Arm - Hard Collar | No intervention | –Patient randomised to wearing a Hard Collar for 12 weeks - standard care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Hard CollarThe patient in the intervention arm will not wear a Hard Collar for 12 weeks post injury | Other | No Hard Collar |
Primary outcome
EQ-5D-5L Score - (EuroQol five dimensional descriptive system)
Time frame: 12 weeks
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.
15 secondary outcomes
EQ-5D-5L Score - (EuroQol five dimensional descriptive system)
Time frame: Measured at 2 and 6 weeks and 6 months post injury
Neck Disability Index (NDI)
Time frame: Measured at 2, 6 and 12 weeks and 6 months post injury
Numeric Pain Rating Scale (NPRS)
Time frame: Measured at 2, 6 and 12 weeks and 6 months post injury
Mortality
Time frame: 6 months post injury
Adverse events
Time frame: Up to 12 weeks post injury
Fracture site bony fusion
Time frame: 12 weeks post injury
Fracture site stability
Time frame: 12 weeks post injury
Loss of muscle bulk in upper limbs - assessed using a combination of grip strength and muscle bio-impedance
Time frame: Measured over 12 weeks
Late injury-related complications
Time frame: Up to 6 months post injury
Total number of hospital admissions or outpatient visits
Time frame: Up to 6 months post injury
Total amount of health and social care visits/use
Time frame: Up to 6 months post injury
Compliance with Hard Collar Use
Time frame: Up to 12 weeks post injury
Length of primary admission
Time frame: The total length of time between a patient's primary admission and their discharge from hospital. Up to 12 weeks after admission.
Discharge destination
Time frame: Noted at point of discharge of participant. Usually within 12 weeks after admission.
Health Economics Analysis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 35840308Woodfield 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.
- Individual participant dataSharing planned: Yes. Anonymised patient-level data will be available on reasonable request to the Chief Investigator (paul.brennan@ed.ac.uk). The trial protocol and statistical analysis plans will be published and available prior to trial completion.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Brennan principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Hard Collar in people with Odontoid Fracture, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D-5L Score - (EuroQol five dimensional descriptive system) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04895644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.