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ACTIVE NOT RECRUITING
NCT05653206

Incomplete Cervical SCI Without Instability

Sponsor: AO Foundation, AO Spine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2023-12-11

Completion Date

2027-08-18

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

PROCEDURE

Nonsurgical treatment

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

PROCEDURE

Surgical treatment

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

Locations (10)

San Francisco General Hospital

San Francisco, California, United States

UMD STC Neurosurgery Clinic

Baltimore, Maryland, United States

Medical college of Winsconsine, Neurosurgery

Milwaukee, Wisconsin, United States

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

São Paulo, Brazil

St. Michael's Hospital

Toronto, Canada

Toronto Western Hospital University Health Network

Toronto, Canada

Vancouver Spine Research Program, Blusson Spinal Cord Centre

Vancouver, Canada

BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau

Murnau am Staffelsee, Germany

Indian Spinal Injuries Centre

New Delhi, India

Orthopaedics, Centro Hospitalar Universitário do Porto

Porto, Portugal