Spinal DeformityNCT03880292
Spinal Deformity Intraoperative Monitoring.
A study testing Document intraoperative Maneuvers in people with Spinal Deformity, run by AO Foundation, AO Spine at 24 sites in 14 countries.
Trial summary
A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Spinal Deformity
- What is being tested?
- Document intraoperative Maneuvers
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 24 sitesin 14 countries
- Study dates
- 15 May 2019to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >10 years to <80 years
- Neurologically intact spinal cord (with or without radiculopathy)
- Undergoing primary or revision procedure in the spine
- Anterior and/or posterior surgical approach for any of the following:
- Correction of spinal deformity with a major Cobb angle of ≥ 80° in the coronal or sagittal plane
- Correction of high grade spondylolisthesis (Grades 3- 5)
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- Posterior column or 3-column osteotomy
- Requiring multimodal neuromonitoring with EMG, SSEP, and MEP as per standard of care
- Informed consent obtained for patients i.e.:
- Ability to understand the content of the patient information
- Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
- Signed and dated EC/IRB approved written informed consent OR
- Written consent obtained according to defined and IRB/EC approved procedures for patients who are not able to provide independent written informed consent
Who cannot join
- Upper motor neuron lesion
- Growing rods or growth guidance procedures
- Tether or staple procedures
- Stand-alone cervical deformity correction procedures
- Any not medically managed severe systemic disease
- Recent history of substance abuse (ie recreational drugs, alcohol) that would preclude reliable assessment
Show all 9Show fewer
- Pregnancy or women planning to conceive within the study period
- Prisoner
- Participation in any other medical device or medicinal product study that could influence the results of the present study
Trial locations and contacts
24 sites in 14 countries.
24 sites in 14 countries
United States5 sites
University of Virginia
Charlottesville, Virginia, 22904
Duke University Medical Center
Durham, North Carolina, 27710
University of Minnesota
Minneapolis, Minnesota, 55454
Columbia University Medical Center
New York, New York, 10032
UC San Franciisco
San Francisco, California, 94143
Canada3 sites
Shriners Hospital for Children
Montreal, 124001
Montreal General Hospital
Montreal
Toronto Western Hospital
Toronto, M5T 2S8
United Kingdom3 sites
Guys Hospital
London
Salford Royal Hospital
Manchester
Nottingham Queens Medical Centre
Nottingham, NG7 2UH
Brazil2 sites
Hospital Infantil Joana de Gusmão
Florianópolis, 88025
Hospital das clinicas de São Paulo e AACD
São Paulo
India2 sites
Mallika Spine Centre
Guntur, 522001
Kothari Medical Centre
Kolkata, 700027
About this study
Official title: SDIM: Spinal Deformity Intraoperative Monitoring. Understanding and Managing Intraoperative Neuromonitoring Changes During Spinal Deformity Surgery: a Prospective Interventional Study
A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Baseline, intraoperative, and postoperative characteristics, including demographics, radiological features, lower extremity motor score (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for either adult patients or pediatric patients.
Read the detailed description
A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Baseline, intraoperative, and postoperative characteristics, including demographics, radiological features, lower extremity motor score (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for either adult patients or pediatric patients.
If a major change occurs in the intraoperative neuromonitoring, defined as a loss of amplitude greater than 50% in the MEP or SSEP from baseline or sustained EMG activity, a separate form (Appendix 3, Intraoperative Alert Form) will be completed in real-time by the neuromonitoring technician outlining the timing of the alert, blood pressure at the time, surgical events at the time of the change, intraoperative maneuvers performed to address the change, and resultant outcome of these maneuvers to address the neuromonitoring change. For each alert occurring during the procedure, a separate form will be completed.
Once the patient is awake from anesthesia, the treating surgeon will perform a neurological examination to identify details about the deficit including sidedness, LEMS, sensory deficit, injury to the nerve root, incomplete spinal cord (ie anterior cord, posterior cord, central cord, Brown-Sequard), complete spinal cord injury, conus or cauda equina deficit. The examination is repeated on the day of discharge from hospital, or at day 30, whichever comes first and documented in the corresponding form.
The objective of this study is to identify the incidence of intraoperative alerts in high-risk spinal cord cases, correlate significant neuromonitoring changes to intraoperative events, and identify maneuvers that will restore the neuromonitoring changes to baseline. The information provided by this study will educate spinal surgeons to recognize a spinal cord at risk and to perform intraoperative maneuvers that will decrease the incidence of neurological injuries.
- Conditions
- Spinal Deformity
- Being tested
- Document intraoperative Maneuvers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Document intraoperative ManeuversProcedure or surgery
Monitoring procedure during surgery
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Maneuvers | Other | To document intraoperative maneuvers performed in response to alerts Receives: Procedure: Document intraoperative Maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Had at Least One Intraoperative Neuromonitoring Alert
Number of intraoperative neuromonitoring alert, defined as a major change in neuromonitoring signals:
- SSEP: amplitude loss > 50%
- MEP: amplitude loss > 50% in two of three muscle groups and/or
- EMG: sustained activity for > 10 seconds
Measured: Intraoperative, on average 6.3 hours
Secondary outcomes (4)
Number of Patients With IONM Alerts by Modality Combination
Count of IONM alerts and modalities affected
Measured: Intraoperative, on average 6.3 hours
Preceding Events
Data from the safety set was used to analyze the events preceding the alerts.
Measured: Intraoperative, on average 6.3 hours
De Novo Neurological Deficit
A de novo neurological deficit is defined as:
- Postoperative decrease of one point from baseline in the ASIA LEMS
- Worsening in sensory function from baseline
- Presence of spinal cord syndrome
Measured: At discharge or 30 days postoperative (which ever occurs first)
Number of Patient With Different Recovery Status of Alerts
Status of alert recovery
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start15 May 2019
- Primary completion31 Mar 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal DeformityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Foundation, AO Spine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880292
- Sponsor's protocol ID
- SDIM
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2019
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SDIM: Spinal Deformity Intraoperative Monitoring. Understanding and Managing Intraoperative Neuromonitoring Changes During Spinal Deformity Surgery: a Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT03880292
- Acronym / sponsor ID
- SDIM
- Conditions
- Spinal Deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- AO Foundation, AO SpineUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 6 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Baseline, intraoperative, and postoperative characteristics, including demographics, radiological features, lower extremity motor score (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for either adult patients or pediatric patients.
Detailed description
A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Baseline, intraoperative, and postoperative characteristics, including demographics, radiological features, lower extremity motor score (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for either adult patients or pediatric patients.
If a major change occurs in the intraoperative neuromonitoring, defined as a loss of amplitude greater than 50% in the MEP or SSEP from baseline or sustained EMG activity, a separate form (Appendix 3, Intraoperative Alert Form) will be completed in real-time by the neuromonitoring technician outlining the timing of the alert, blood pressure at the time, surgical events at the time of the change, intraoperative maneuvers performed to address the change, and resultant outcome of these maneuvers to address the neuromonitoring change. For each alert occurring during the procedure, a separate form will be completed.
Once the patient is awake from anesthesia, the treating surgeon will perform a neurological examination to identify details about the deficit including sidedness, LEMS, sensory deficit, injury to the nerve root, incomplete spinal cord (ie anterior cord, posterior cord, central cord, Brown-Sequard), complete spinal cord injury, conus or cauda equina deficit. The examination is repeated on the day of discharge from hospital, or at day 30, whichever comes first and documented in the corresponding form.
The objective of this study is to identify the incidence of intraoperative alerts in high-risk spinal cord cases, correlate significant neuromonitoring changes to intraoperative events, and identify maneuvers that will restore the neuromonitoring changes to baseline. The information provided by this study will educate spinal surgeons to recognize a spinal cord at risk and to perform intraoperative maneuvers that will decrease the incidence of neurological injuries.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Maneuvers | Other | Procedure: Document intraoperative ManeuversTo document intraoperative maneuvers performed in response to alerts |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Age >10 years to <80 years
- Neurologically intact spinal cord (with or without radiculopathy)
- Undergoing primary or revision procedure in the spine
- Anterior and/or posterior surgical approach for any of the following:
- Requiring multimodal neuromonitoring with EMG, SSEP, and MEP as per standard of care
Key exclusion criteria (9 listed)
- Upper motor neuron lesion
- Growing rods or growth guidance procedures
- Tether or staple procedures
- Stand-alone cervical deformity correction procedures
- Any not medically managed severe systemic disease
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 |
|---|---|---|
| Document intraoperative ManeuversMonitoring procedure during surgery | Procedure or surgery | Intraoperative Maneuvers |
Primary outcome
Number of Patients Who Had at Least One Intraoperative Neuromonitoring Alert
Time frame: Intraoperative, on average 6.3 hours
Number of intraoperative neuromonitoring alert, defined as a major change in neuromonitoring signals: * SSEP: amplitude loss > 50% * MEP: amplitude loss > 50% in two of three muscle groups and/or * EMG: sustained activity for > 10 seconds
4 secondary outcomes
Number of Patients With IONM Alerts by Modality Combination
Time frame: Intraoperative, on average 6.3 hours
Preceding Events
Time frame: Intraoperative, on average 6.3 hours
De Novo Neurological Deficit
Time frame: At discharge or 30 days postoperative (which ever occurs first)
Number of Patient With Different Recovery Status of Alerts
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Document intraoperative Maneuvers in people with Spinal Deformity, run by AO Foundation, AO Spine at 24 sites in 14 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 13 inclusion and 9 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada, United Kingdom, Brazil, India and 9 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?
Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Who Had at Least One Intraoperative Neuromonitoring Alert (time frame: Intraoperative, on average 6.3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.