The SCI-POEM Study (v1.0)
Research type
Research Study
Full title
Prognostic Factors and Therapeutic Effects of Surgical Treatment for Traumatic Spinal Column Injury with Spinal Cord Injury: A Prospective, Observational European Multi-center (SCI-POEM) Study.
IRAS ID
116619
Contact name
JJ van Middendorp
Contact email
Sponsor organisation
AOSpine Europe
Clinicaltrials.gov Identifier
Research summary
The role of early surgical treatment in the management of patients who sustained a traumatic spinal cord injury (tSCI) has been one of the most debated topics in the management of tSCI for many years. However, despite years of discussions and research, no conclusive data related to the role of the timing of decompressive surgery (of the spinal cord and column) have been published to date.
We propose a prospective, observational European multi-center comparative cohort study, which has the acronym “SCI-POEM”, designed to evaluate the effectiveness of early surgical treatment for patients who sustained a tSCI. In 12 European trauma centres across Europe – including 3 UK Trauma centres –, we will compare outcomes between SCI patients who undergo acute (<12 hours) and non-acute (>12 hours, <2 weeks) surgical treatment of the injured spine.
Where randomisation (acute or non-acute surgical treatment) of patients comes with a variety of practical and ethical difficulties, we propose a next-best study design: an observational comparative study design. The primary objective of the study is to investigate the difference in the neurological outcomes between the two groups by measuring the change in muscle strength of the legs between the time before surgical treatment and 1 year later. Other neurological outcomes and daily functional activities are secondary outcomes of interest. Complications will be recorded according to a pre-specified list of definitions. As non-randomised studies are susceptible of bias and invalid outcomes, we will apply statistical techniques to correct for bias as much as possible.
After a recruitment period of 3 years, we expect to have included 300 patients. A significant difference in safety and/or efficacy endpoints will provide meaningful information to clinicians, as this would confirm the hypothesis that rapid referral to and treatment in specialized centres result in important improvements in tSCI patients.
REC name
London - Harrow Research Ethics Committee
REC reference
13/LO/0653
Date of REC Opinion
14 Aug 2013
REC opinion
Further Information Favourable Opinion