Incomplete Cervical SCI Without Instability

NCT05653206 | Active Not Recruiting

• 1 other identifier: IN-TWIN
• Study Type: observational
• Target: 50
• Locations: 6 countries
• Sites: 10

Brief Summary

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

Outcome Measures

Primary Outcomes (7)

• The proportion of the core outcome assessments successfully completed at each visit

  For baseline and each FU visit, the completion status of each core outcome assessment

  up to 6 months

• Time required to complete the individual core outcome assessments

  For baseline and each FU visit, the time required for completion for each core outcome assessment will be recorded (start time, end time, and duration in mins)

  up to 6 months

• Total time required to complete all core outcome assessments at each visit

  The time required for completion will be measured to the nearest 0.1 second by using a digital timer, and the timing should start at the start of giving instructions to the patients or explaining the tests to the patients (start time) and end when the final score of the test is obtained (end time).

  up to 6 months

• Completion rate of individual core outcome assessments (and their scorings if applicable)

  Completion rate of individual core outcome assessments at each visit.

  up to 6 months

• Completion rate of the multiparametric quantitative spinal cord MRI/DTI

  Completion rate of the multiparametric quantitative spinal cord MRI/DTI

  up to 6 months

• FU visit compliance rate and reasons for non-compliance

  Completion status of FU visits, recorded at 3- and 6-month visits

  up to 6 months

• Patient accrual rate

  Whether the patient drops out from the study, recorded at the time of dropout

  up to 6 months

Secondary Outcomes (7)

• Results from the core outcome assessment ISNCSCI

  up to 6 months

• Results from the core outcome assessment SF-36 v2

  up to 6 months

• Results from the core outcome assessment Neuropathic pain score

  up to 6 months

• Results from the core outcome assessment SCIMv3

  up to 6 months

• Results from the core outcome assessment WISCI v2

  up to 6 months

Interventions

Nonsurgical treatment PROCEDURE

Cervical collar, Halo ring, Halo vest, cervical braces, skeletal skull traction, MAP, steroids, observation or bedrest

Surgical treatment PROCEDURE

Anterior discectomy and instrumented fusion (single level), Anterior discectomy and instrumented fusion (multi-level), Posterior decompression-laminectomy, Posterior decompression-laminoplasty, Posterior decompression and instrumented fusion, Combined anterior and posterior decompression and instrumented fusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with traumatic incomplete cervical SCI without instability

You may qualify if:

• Age 18-80 years, inclusive
• Diagnosis of acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only within 92 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Foundation, AO Spine: lead

Study Sites (10)

San Francisco General Hospital

San Francisco, California, 94143, United States

Location

UMD STC Neurosurgery Clinic

Baltimore, Maryland, 21201, United States

Location

Medical college of Winsconsine, Neurosurgery

Milwaukee, Wisconsin, 53226, United States

Location

Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo

São Paulo, 05403-010, Brazil

Location

St. Michael's Hospital

Toronto, M5B1W8, Canada

Location

Toronto Western Hospital University Health Network

Toronto, M6S2W5, Canada

Location

Vancouver Spine Research Program, Blusson Spinal Cord Centre

Vancouver, V5Z 1M9, Canada

Location

BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau

Murnau am Staffelsee, 82418, Germany

Location

Indian Spinal Injuries Centre

New Delhi, 110070, India

Location

Orthopaedics, Centro Hospitalar Universitário do Porto

Porto, 4099-001, Portugal

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Jefferson Wilson

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 16, 2022
• Study Start: December 11, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 18, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); PT (1); US (3); CA (3); IN (1); DE (1)