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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial

Authors: Anna-Lena Robinson, Gregor Schmeiser, Yohan Robinson, Claes Olerud

Published in: Trials | Issue 1/2018

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Abstract

Background

Displaced odontoid fractures in the elderly are treated non-surgically with a cervical collar or surgically with C1–C2 fusion. Due to the paucity of evidence, the treatment decision is often left to the discretion of the expert surgeon.

Methods

The Uppsala Study on Odontoid Fracture Treatment (USOFT) is a multicentre, open-label, randomised controlled superiority trial evaluating the clinical superiority of the surgical treatment of type-2 odontoid fractures, with a 1-year Neck Disability Index (NDI) as the primary endpoint. Fifty consecutive patients aged ≥ 75 years, with displaced type-2 odontoid fracture, are randomised to non-surgical or surgical treatment. Excluded are patients with an American Society of Anaesthesiologists (ASA) score ≥ 4, dementia nursing care or anatomical cervical anomalies.
The minimal clinically important difference of the NDI is 3.5 points. A minimum of 16 patients are needed in each group to test the superiority with 80% power. By considering a 1-year mortality forecast of 29%, up to 25 participants are recruited in each group.
The non-surgical group is fitted with a rigid cervical collar for 12 weeks. The surgical group is treated with a posterior C1–C2 fusion. All participants are monitored with regard to the NDI, EuroQol score (EQ-5D), socio-demographics and computed tomography (CT) at the time of injury, at 6 weeks, 3 months and 12 months. At 12 months, a dynamic radiographical investigation of upper cervical stability is performed.
The secondary endpoints are: EQ-5D score, activities of daily living (ADL), bony union, upper cervical stability and mortality.

Discussion

USOFT is the first randomised controlled trial comparing non-surgical and surgical management of type-2 odontoid fractures in the elderly. Using the NDI and EQ-5D as endpoints, future value-based decisions may consider quality-adjusted life years gained. Major limitations are (1) the allocation bias of the open-label study design, (2) that only higher training levels of all core specialties of spine surgery are included in the surgical treatment arm and (3) that only one type of surgical stabilisation is investigated (posterior C1–C2 fusion), while other methods are not included in this study.

Trial registration

ClinicalTrials.​gov, NCT02789774. Registered retrospectively on 25 August 2015.
Appendix
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Metadata
Title
Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial
Authors
Anna-Lena Robinson
Gregor Schmeiser
Yohan Robinson
Claes Olerud
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2690-8

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