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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03880292




Registration number
NCT03880292
Ethics application status
Date submitted
13/03/2019
Date registered
19/03/2019
Date last updated
13/08/2019

Titles & IDs
Public title
Spinal Deformity Intraoperative Monitoring.
Scientific title
SDIM: Spinal Deformity Intraoperative Monitoring. Understanding and Managing Intraoperative Neuromonitoring Changes During Spinal Deformity Surgery: a Prospective Observational Study
Secondary ID [1] 0 0
SDIM
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Deformity 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Document intraoperative Maneuvers

Other: Intraoperative Maneuvers - To document intraoperative maneuvers performed in repsonse to alerts


Treatment: Surgery: Document intraoperative Maneuvers
Monitoring procedure during surgery

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of intraoperative neuromontoring alerts - 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
Timepoint [1] 0 0
Intraoperative
Secondary outcome [1] 0 0
Intraoperative monitoring alert - Intraoperative monitoring alerts:
• Degree of change in the monitoring signals (SSEP, MEP, EMG)
Timepoint [1] 0 0
Intraoperative
Secondary outcome [2] 0 0
Success rate of reversal maneuvers to restore signal above the threshold - Number and type of maneuver(s) in response to an alert
number and type of successful maneuvers
number and type of unsuccessful maneuvers
Timepoint [2] 0 0
Intraoperative
Secondary outcome [3] 0 0
Neurological status - Neurological status:
• ASIA Lower extremity motor and sensory score including if a spinal cord syndrome is applicable. A scale from 0 to 5 points in which 0 denotes total paralysis and 5 normal active movement. Sensory will be meassured as either normal, altered or absent.
Timepoint [3] 0 0
Baseline up to 30 days postoperative
Secondary outcome [4] 0 0
Timing of intraoperative monitoring alerts - Timing: Minutes since skin incision and minutes until recovery in MEP and SSEP
Timepoint [4] 0 0
Intraoperative

Eligibility
Key inclusion criteria
- 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)

- 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
Minimum age
10 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Neurodegenerative disease

- 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

- 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
Brazil
State/province [4] 0 0
Florianópolis
Country [5] 0 0
Canada
State/province [5] 0 0
Montréal
Country [6] 0 0
Canada
State/province [6] 0 0
Toronto
Country [7] 0 0
China
State/province [7] 0 0
Nanjing
Country [8] 0 0
Hong Kong
State/province [8] 0 0
Hong Kong
Country [9] 0 0
India
State/province [9] 0 0
Guntur
Country [10] 0 0
India
State/province [10] 0 0
Kolkata
Country [11] 0 0
Japan
State/province [11] 0 0
Hamamatsu
Country [12] 0 0
Pakistan
State/province [12] 0 0
Lahore
Country [13] 0 0
South Africa
State/province [13] 0 0
Kapstadt
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Turkey
State/province [15] 0 0
Istanbul
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AOSpine International
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/show/NCT03880292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joffrey Baczkowski
Address 0 0
Country 0 0
Phone 0 0
+41 44 200 24 31
Fax 0 0
Email 0 0
joffrey.baczkowski@aofoundation.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03880292