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19/82 Conservative management of odontoid fracture in the elderly: to immobilise or not?

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question: In older adults with image confirmed cervical spine odontoid fracture where surgical fixation is not indicated or considered appropriate, does a management strategy with no immobilisation lead to better or worse outcomes than management with immobilisation?

  1. Intervention: Management strategy not involving immobilisation (applicants to define).
  2. Patient group: Older adults (applicants to define and justify) with imaging confirmed cervical odontoid (C2) fracture in whom surgery is not indicated or considered suitable/appropriate (applicants to define). Applicants to consider sub-group analyses based on type of C2 fracture as well as different age ranges, and co-morbidities such as level of frailty and cognitive impairment.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Emergency department/secondary care.
  4. Control: Management strategy using immobilisation such as a cervical collar (e.g. soft or hard, for the applicants to define types).
  5. Study design: A randomised controlled trial with an internal pilot phase to test the ability to recruit, randomise and to check levels of adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: Applicants to define most important outcomes on which the study should be powered but should consider including elements of the following: Functional outcomes, morbidity (for example, aspiration pneumonia, delirium, need for 1:1 nursing, pressure areas on collar, impact on swallowing); Quality of life; acceptability; adherence.
    Other outcomes: Mortality; need for intervention/surgery.
  7. Minimum duration of follow-up: Applicants to define and justify.

Rationale:

The number of odontoid fractures of the C2 vertebrae seen in the emergency department is increasing due to the aging population who often sustain this injury through falls. Indeed, such fractures are the most common injury of the cervical spine in the elderly.

How best to manage many of these patients remains a clinical conundrum. In those with significantly displaced fractures surgery will usually be indicated, but for those with non-displaced stable fractures conservative management with a hard cervical collar or halo device is often used as an alternative. Some patients with unstable fractures who are indicated for surgery are deemed too medically unwell to go through surgery and these patients are typically managed conservatively.

Use of such immobilisation devices does not come without risks though, and complications of use (pressure sores, aspiration pneumonia, dysphagia etc.) are not uncommon. Previous concerns about the potential impact of malunion of these broken bones is reducing with growing evidence that patient reported outcomes and satisfaction of treatment are not necessarily reliant on what would usually be described as clinically confirmed union (i.e. radiologically confirmed).

This is leading clinicians to believe that current conservative management options of  odontoid fractures in the elderly, and in the oldest patients in particular, is still too much of an intervention, and actually doing even less (i.e. no orthoses) is warranted for at least a subset of patients. This though needs to be determined in an adequately powered trial to assess whether, and in which patients, a management strategy not involving immobilisation is acceptable to patients and is safe and effective.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 4th December 2019. Applications will be considered by the HTA Funding Committee at its meeting in January.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May.

Applications received after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email: htacommissioning@nihr.ac.uk

Telephone: Commissioning Funding Committee 02380 595510