Incomplete Cervical SCI Without Instability

Description

A multicenter, international, prospective, observational case series patient cohort with incomplete cervical SCI without instability will be enrolled to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients to capture the aspects of neurologic impairment. Baseline, intraoperative, and postoperative characteristics, including demographics, injury details, treatment details, neurological assessments, gait and balance assessments and upper extremity assessments, will be recorded for adult patients.

Conditions

Cervical Spinal Cord Injury

Study Overview

Study Details

Study overview

A multicenter, international, prospective, observational case series patient cohort with incomplete cervical SCI without instability will be enrolled to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients to capture the aspects of neurologic impairment. Baseline, intraoperative, and postoperative characteristics, including demographics, injury details, treatment details, neurological assessments, gait and balance assessments and upper extremity assessments, will be recorded for adult patients.

IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis

Incomplete Cervical SCI Without Instability

Condition
Cervical Spinal Cord Injury
Intervention / Treatment

-

Contacts and Locations

San Francisco

San Francisco General Hospital, San Francisco, California, United States, 94143

Baltimore

UMD STC Neurosurgery Clinic, Baltimore, Maryland, United States, 21201

Milwaukee

Medical college of Winsconsine, Neurosurgery, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18-80 years, inclusive
  • * Diagnosis of acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only within 48 hours post injury
  • * Cervical neurological level of injury (C2-C8)
  • * MRI, using any imaging protocols (conventional, multiparametric, or quantitative), taken according to standard of care
  • * Presence of spinal cord compression on the MRI
  • * Absence of biomechanical instability to the extent that would mandate stabilization surgery by the treating surgeon
  • * Ability to provide informed consent according to the IRB/EC defined and approved procedures
  • * Nontraumatic SCI
  • * Concomitant traumatic brain injury or polytrauma that could preclude accurate or reliable assessments of the outcome assessments
  • * Uncontrolled severe systemic diseases, preexisting neurological, musculoskeletal, or general medical conditions which could preclude accurate assessments or FUs
  • * Individuals unable to undergo MRI

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AO Foundation, AO Spine,

Jefferson Wilson, PRINCIPAL_INVESTIGATOR, Unity Health Toronto

Study Record Dates

2027-08-01