Acute Spinal Cord Injury of Traumatic Origin (tSCI)SCI-POEMNCT01674764
Surgical Treatment for Spinal Cord Injury
An observational study of Acute Spinal Cord Injury of Traumatic Origin (tSCI), run by AOSpine Europe at 17 sites in 12 countries.
Trial summary
Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for traumatic spinal cord injury (tSCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Spinal Cord Injury of Traumatic Origin (tSCI)
- What is being tested?
- Early surgical intervention and Late surgical intervention
- Type of treatment
- Surgery or procedure
- How many people
- 297 participants
- Where
- 17 sitesin 12 countries
- Study dates
- Nov 2012to Oct 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery. This CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic MRI as mandatory and will be conducted in a European setting where patients are generally transported more swiftly to the treating institution when compared to other geographic regions in the world.
Who may be able to join
- Age 18 years and older
- Diagnosis of blunt spinal column injury and spinal cord injury, including conus medullaris and/or cauda equina injuries
- Pre-surgery ASIA grade A, B, C or D
- Less than 14 days between the injury and surgery
- Ability to understand patient information / informed consent form
- Willingness and ability to participate in the clinical investigation and FU procedures (FUs)
- Informed consent according to local legislations and applicable guidelines
Who cannot join
- Traumatic brain injury: Glasgow Coma Scale (GCS) ≤ 13
- Diagnosis of subclinical or clinical polyneuropathy (eg. presence of bilateral impairment of strength, sensation, and/or deep tendon reflexes with symmetrical and distal distribution and/or neurophysiological abnormalities)
- Spinal cord injury caused by a penetrating injury
- Non-traumatic or pathologic fractures or cord compression (eg, tumor or infection)
- Unable to cooperate with physical examination (pre-operative, ≤ 2 weeks) because of cognitive impairment, as assessed by the examiner
- Previous spinal column or spinal cord injury
Show all 14Show fewer
- Diagnosis of spondyloarthropathy (inflammatory or non-inflammatory)
- Morbid Obesity: Body Mass Index (BMI) > 35
- Any severe systemic disease that may have an influence on motor function (eg, polyneuropathy)
- ASA classification score ≥ 4
- Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
- Pregnancy at the time of inclusion
- Prisoner
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Trial locations and contacts
17 sites in 12 countries.
17 sites in 12 countries
United Kingdom3 sites
King's College Hospital
London, SE5 9RS
Queens's Medical Centre Campus
Nottingham, NG7 2UH
Nuffield Orthopaedic Centre Headington
Oxford, OX3 7LD
Germany2 sites
BG Unfallklinik Frankfurt
Frankfurt, 60389
Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Ludwigshafen, 67071
Italy2 sites
Ospedale Maggiore
Bologna, 40133
Policlinico Umberto Primo
Rome, 00161
Netherlands2 sites
University Medical Center St. Radboud
Nijmegen, 6500 HB
University Medical Center Utrecht
Utrecht, 3508 GA
Bulgaria1 site
National Institute of Emergency Medicine "N.I. Pirogov"
Sofia, 1606
Turkey (Türkiye)1 site
Gazi University Faculty of Medicine
Ankara, 06000
About this study
Official title: Prognostic Factors and Therapeutic Effects of Surgical Treatment for Traumatic Spinal Column Injury With Spinal Cord Injury: A Prospective, Observational European Multi-center Study.
Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for traumatic spinal cord injury (tSCI). Although there is increasing experimental evidence from animal models that surgical decompression of the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data yet. The main explanations for this lack of convincing evidence are relatively small sample sizes in previous studies, their predominantly retrospective nature, suboptimal measurement methods for the assessment of neurological deficits, and inappropriate recording and documentation of potential confounding factors.
Read the detailed description
Although injuries to the spinal column represent a relatively small proportion of all traumatic injuries, spinal injuries have one of the highest impacts on functional outcomes and employment status. Even more than an injury of the spinal column, traumatic spinal cord injury (tSCI) is a devastating disorder severely affecting patients' physical and psychosocial well-being. The incidence of tSCI is estimated to be 11 to 53 new cases per million population per year.
This is a multi-center, prospective, observational cohort study to evaluate if early (≤ 12 hours after the tSCI) surgical decom¬pression is superior to late (> 12 hours and < 14 days after the tSCI) in improving neurologic motor outcomes in patients with acute traumatic spinal cord injury.
The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery. This CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic MRI as mandatory and will be conducted in a European setting where patients are generally transported more swiftly to the treating institution when compared to other geographic regions in the world.
Patients will be evaluated according to the schedule set forth in this CIP. The schedule includes evaluations at pre-surgery, post-surgery, 72 hours post injury, 12 weeks ± 2 weeks; 6 months ± 30 days; 1 year ± 30 days. The enrollment period is expected to be approximately 36 months and subjects will be followed-up for 12 months for the evaluation of the primary endpoint. The study duration is approximately 48 months.
- Being tested
- Early surgical intervention, Late surgical intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early surgical interventionProcedure or surgery
Also called ≤ 12 hours after the tSCI
Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation
Late surgical interventionProcedure or surgery
Also called > 12 hours and < 14 days after the tSCI
Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation
| Study group | Role | What they receive |
|---|---|---|
| Early surgical intervention = Cohort 1 | ≤ 12 hours after the tSCI Receives: Procedure: Early surgical intervention | |
| Late surgical intervention = Cohort 2 | > 12 hours and < 14 days after the tSCI Receives: Procedure: Late surgical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in American Spinal Injury Association Lower Extremities Motor Score (ASIALEMS) between pre-surgery and 1-year post-surgery FU
Measured: Between pre-surgery and 1-year post-surgery
Secondary outcomes (7)
Change in American Spinal Injury Association Motor Score (ASIAMS) between pre-surgery and 1-year FU
Measured: Pre-surgery and 1-year FU
Change in American Spinal Injury Association Upper Extremities Motor Score (ASIAUEMS) between pre-surgery and 1-year FU
Measured: Between pre-surgery and 1-year FU
Change in American Spinal Injury Association Impairment Scale (AIS) between pre-surgery and 1-year FU
Measured: Between pre-surgery and 1-year FU
Change in American Spinal Injury Association Sensory Score (ASIASS) between pre-surgery and 1-year FU
Measured: Between pre-surgery and 1-year FU
Spinal Cord Independency Measure (SCIM) at the 6-month and 1-year FU
Measured: 6-month and 1-year FU
Change in quality of life using the Short version of the World Health Organization Quality-of-Life questionnaire (WHOQOL-BREF) between pre-injury and 1-year FU
Measured: Pre-injury and 1-year FU
Rate of treatment related adverse events, as assessed by an independent evaluator
Measured: Until the 1-year FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2019
- Study completionOct 2019
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 Acute Spinal Cord Injury of Traumatic Origin (tSCI)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOSpine Europe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allard JF Hosman, MD, PhD, Principal investigator, Medical Co-Director Spine Unit, Radboud University Medical Centre, 6500 Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674764
- Sponsor's protocol ID
- SCI-POEM
- Acronym
- SCI-POEM
- Status last verified
- May 2020
- First submitted
- 22 Aug 2012
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Romijn P, Kussige PGP, van Hooff ML, Evaniew N, van de Meent H, van Middendorp JJ, Pouw MH, Hosman AJF. Early versus late surgical decompression in acute traumatic spinal cord injury: does it impact the quality of life? Spinal Cord. 2026 Feb;64(2):142-150. doi: 10.1038/s41393-025-01165-y. Epub 2025 Dec 27.
PubMed 41455816
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors and Therapeutic Effects of Surgical Treatment for Traumatic Spinal Column Injury With Spinal Cord Injury: A Prospective, Observational European Multi-center Study.
- ClinicalTrials.gov ID
- NCT01674764
- Acronym / sponsor ID
- SCI-POEM / SCI-POEM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- AOSpine EuropeIndustry (pharma, biotech, devices)
- Study start
- Nov 2012 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 29 Aug 2012 (estimated)
- 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.
Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for traumatic spinal cord injury (tSCI). Although there is increasing experimental evidence from animal models that surgical decompression of the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data yet. The main explanations for this lack of convincing evidence are relatively small sample sizes in previous studies, their predominantly retrospective nature, suboptimal measurement methods for the assessment of neurological deficits, and inappropriate recording and documentation of potential confounding factors.
Detailed description
Although injuries to the spinal column represent a relatively small proportion of all traumatic injuries, spinal injuries have one of the highest impacts on functional outcomes and employment status. Even more than an injury of the spinal column, traumatic spinal cord injury (tSCI) is a devastating disorder severely affecting patients' physical and psychosocial well-being. The incidence of tSCI is estimated to be 11 to 53 new cases per million population per year.
This is a multi-center, prospective, observational cohort study to evaluate if early (≤ 12 hours after the tSCI) surgical decom¬pression is superior to late (> 12 hours and < 14 days after the tSCI) in improving neurologic motor outcomes in patients with acute traumatic spinal cord injury.
The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery. This CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic MRI as mandatory and will be conducted in a European setting where patients are generally transported more swiftly to the treating institution when compared to other geographic regions in the world.
Patients will be evaluated according to the schedule set forth in this CIP. The schedule includes evaluations at pre-surgery, post-surgery, 72 hours post injury, 12 weeks ± 2 weeks; 6 months ± 30 days; 1 year ± 30 days. The enrollment period is expected to be approximately 36 months and subjects will be followed-up for 12 months for the evaluation of the primary endpoint. The study duration is approximately 48 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early surgical intervention = Cohort 1 | – | Procedure: Early surgical intervention≤ 12 hours after the tSCI |
| Late surgical intervention = Cohort 2 | – | Procedure: Late surgical intervention> 12 hours and < 14 days after the tSCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll 300 patients with anticipated 1:2 ratio of early vs. late surgery. This CIP is not limited to cervical spinal cord injuries, does not consider a diagnostic MRI as mandatory and will be conducted in a European setting where patients are generally transported more swiftly to the treating institution when compared to other geographic regions in the world.
Key inclusion criteria (7 listed)
- Age 18 years and older
- Diagnosis of blunt spinal column injury and spinal cord injury, including conus medullaris and/or cauda equina injuries
- Pre-surgery ASIA grade A, B, C or D
- Less than 14 days between the injury and surgery
- Ability to understand patient information / informed consent form
Key exclusion criteria (14 listed)
- Traumatic brain injury: Glasgow Coma Scale (GCS) ≤ 13
- Diagnosis of subclinical or clinical polyneuropathy (eg. presence of bilateral impairment of strength, sensation, and/or deep tendon reflexes with symmetrical and distal distribution and/or neurophysiological abnormalities)
- Spinal cord injury caused by a penetrating injury
- Non-traumatic or pathologic fractures or cord compression (eg, tumor or infection)
- Unable to cooperate with physical examination (pre-operative, ≤ 2 weeks) because of cognitive impairment, as assessed by the examiner
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 |
|---|---|---|
| Early surgical interventionAlso: ≤ 12 hours after the tSCIOpen surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation | Procedure or surgery | Early surgical intervention = Cohort 1 |
| Late surgical interventionAlso: > 12 hours and < 14 days after the tSCIOpen surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation | Procedure or surgery | Late surgical intervention = Cohort 2 |
Primary outcome
Change in American Spinal Injury Association Lower Extremities Motor Score (ASIALEMS) between pre-surgery and 1-year post-surgery FU
Time frame: Between pre-surgery and 1-year post-surgery
7 secondary outcomes
Change in American Spinal Injury Association Motor Score (ASIAMS) between pre-surgery and 1-year FU
Time frame: Pre-surgery and 1-year FU
Change in American Spinal Injury Association Upper Extremities Motor Score (ASIAUEMS) between pre-surgery and 1-year FU
Time frame: Between pre-surgery and 1-year FU
Change in American Spinal Injury Association Impairment Scale (AIS) between pre-surgery and 1-year FU
Time frame: Between pre-surgery and 1-year FU
Change in American Spinal Injury Association Sensory Score (ASIASS) between pre-surgery and 1-year FU
Time frame: Between pre-surgery and 1-year FU
Spinal Cord Independency Measure (SCIM) at the 6-month and 1-year FU
Time frame: 6-month and 1-year FU
Change in quality of life using the Short version of the World Health Organization Quality-of-Life questionnaire (WHOQOL-BREF) between pre-injury and 1-year FU
Time frame: Pre-injury and 1-year FU
Rate of treatment related adverse events, as assessed by an independent evaluator
Time frame: Until the 1-year FU
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 13 May 2020.
- Derived from this study: PubMed 41455816Romijn P, Kussige PGP, van Hooff ML, Evaniew N, van de Meent H, van Middendorp JJ, Pouw MH, Hosman AJF. Early versus late surgical decompression in acute traumatic spinal cord injury: does it impact the quality of life? Spinal Cord. 2026 Feb;64(2):142-150. doi: 10.1038/s41393-025-01165-y. Epub 2025 Dec 27.
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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.
Allard JF Hosman, MD, PhD principal investigator
Medical Co-Director Spine Unit, Radboud University Medical Centre, 6500 Nijmegen, The Netherlands
17 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Spinal Cord Injury of Traumatic Origin (tSCI), run by AOSpine Europe at 17 sites in 12 countries.
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 7 inclusion and 14 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 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom, Germany, Italy, Netherlands, Austria and 7 more countries. 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?
Change in American Spinal Injury Association Lower Extremities Motor Score (ASIALEMS) between pre-surgery and 1-year post-surgery FU (time frame: Between pre-surgery and 1-year post-surgery). 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 NCT01674764, 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 13 May 2020.