Spinal Deformity Intraoperative Monitoring.

NCT03880292 | Completed DMC

• 1 other identifier: SDIM
• Study Type: interventional
• Target: 569
• Locations: 14 countries
• Sites: 24

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.

Conditions

Spinal Deformity

Outcome Measures

Primary Outcomes (1)

• 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

  Intraoperative

Secondary Outcomes (4)

• Intraoperative monitoring alert

  Intraoperative

• Success rate of reversal maneuvers to restore signal above the threshold

  Intraoperative

• Neurological status

  Baseline up to 30 days postoperative

• Timing of intraoperative monitoring alerts

  Intraoperative

Study Arms (1)

Intraoperative Maneuvers

OTHER

To document intraoperative maneuvers performed in repsonse to alerts

Procedure: Document intraoperative Maneuvers

Interventions

Document intraoperative Maneuvers PROCEDURE

Monitoring procedure during surgery

Intraoperative Maneuvers

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Foundation, AO Spine: lead

Study Sites (24)

UC San Franciisco

San Francisco, California, 94143, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Royal North Shore Hospital

Saint Leonards, 2065, Australia

Location

Hospital Infantil Joana de Gusmão

Florianópolis, 88025, Brazil

Location

Hospital das clinicas de São Paulo e AACD

São Paulo, Brazil

Location

Shriners Hospital for Children

Montreal, 124001, Canada

Location

Montreal General Hospital

Montreal, Canada

Location

Toronto Western Hospital

Toronto, M5T 2S8, Canada

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Mallika Spine Centre

Guntur, 522001, India

Location

Kothari Medical Centre

Kolkata, 700027, India

Location

Tel Aviv Medical Center - Dana Children's Hospital

Tel Aviv, Israel

Location

Hamamatsu University School of Medicine

Hamamatsu, Japan

Location

University Medical Center St. Radboud

Nijmegen, Netherlands

Location

Ghurki Trust Teaching Hospital

Lahore, Pakistan

Location

Hospital Vall d'Helbron

Barcelona, 08035, Spain

Location

Acibadem Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

Guys Hospital

London, United Kingdom

Location

Salford Royal Hospital

Manchester, United Kingdom

Location

Nottingham Queens Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: May 15, 2019
• Primary Completion: March 31, 2022
• Study Completion: November 1, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

PA (1); US (5); IL (1); ES (1); JP (1); TU (1); AU (1); HK (1); CN (1); CA (3); GB (3); BR (2); NL (1); IN (2)