Clinical Outcomes of Conservatively Managed Odontoid Fractures
Research type
Research Study
Full title
Pain and disability following conservatively managed type II odontoid peg fracture in the elderly. A cross sectional observational study
IRAS ID
231129
Contact name
David Bell
Contact email
Sponsor organisation
King's College Hospital
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Type II odontoid process fractures (a type of fracture in the second cervical vertebrae) are the most common cervical spine fractures in the elderly occurring usually after a low-energy fall. With the aging population the incidence is increasing.
There is uncertainty in the best management of type II odontoid fractures, especially for the very elderly (≥80 years). Options include surgical management or immobilisation in a rigid collar for at least 12 weeks. However many people do not demonstrate bony healing (non-union) after 12 weeks in a collar, and if the injury appears stable on dynamic x-rays, a decision is often made to remove the collar. Although surgery may improve the rate of bony healing the clinical relevance of a stable non-union is unclear.
This retrospective study aims to compare neck pain, quality of life and disability in older people who demonstrate bony union to those with non-union following non-surgical management of a type II odontoid process fracture.
Electronic patient records will be searched for all patients managed at King’s College Hospital for a type II odontoid process fracture from 2008-2018. Electronic records will be used to retrieve clinical and demographic data. All surviving patients will be posted self-completed questionnaires to assess their neck pain, quality of life and disability. As a safety measure we will compare survival status between those that demonstrate osseous union and those with non-union.
The results of the study will inform clinical practice and assist with planning a future qualitative research study on decision making in the elderly with a type II Odontoid fracture.
A6-2: Summary of main issues:
Purpose and design: To date, studies on symptoms (pain and disability) in patients following non-union of conservatively managed type II odontoid process fractures have had very small sample sizes. The largest Molinari et al (2012)(n=34), reported non-statistically significant differences in pain and disability compared to an aged matched control group 14 months post-injury. Repeat studies with a larger sample size and long term follow up is required to increase confidence in results.King’s College Hospital has managed conservatively approximately 150 elderly patients with type II odontoid process fractures which resulted in non-union. We therefore anticipate this will be the largest cohort studied.
The outcome of this cross-sectional retrospective study will yield valuable information regarding pain and disability following conservatively managed type II odontoid process fractures. The results of the study will inform clinical practice and assist with planning a future qualitative research study on decision making in the elderly with a type II Odontoid fracture.
Recruitment: All surviving patients managed at King's College Hospital between 2008-2018 with a type II odontoid process fracture that meet the eligibility criteria will be initially telephoned and informed of the study, given the opportunity to ask questions and invited to participate. If interested they will be posted the participant information sheet, consent form, demographic questionnaire and the four questionnaires and a return stamped addressed envelope. If the questionnaires are not returned potential participants will be reminded (once) to return the questionnaires unless requested not to. Any potential participants that cannot be contacted on the telephone will not be contacted by post. Potential participants may decline to participate at any point.
Consent: Consent will be assumed with the return of completed questionnaires.
Risks, burdens, benefits: There is no risk in taking part. 3 patient representatives have reviewed the questionnaires and have advised that the questionnaires are not burdensome to complete.Confidentiality: Electronic patient notes will be only reviewed to collect relevant clinical and demographic data relevant to the study. All participants will be allocated a unique patient identifier number. Patient identifiable data will not be transferred external to King's College Hospital. All electronic date will be stored on NHS computers and comply with King's College Hospital Information Governance Policies.
Any paper identifiable data will be kept within a locked filing cabinet within a secure room on King's College Hospital site for the duration of the study. They will be scanned into patient electronic notes and securely archived.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0153
Date of REC Opinion
14 May 2018
REC opinion
Favourable Opinion