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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05653206
Other study ID # IN-TWIN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 11, 2023
Est. completion date May 1, 2025

Study information

Verified date March 2024
Source AO Foundation, AO Spine
Contact Alix Frischknecht
Phone +41 79 606 41 48
Email alix.frischknecht@aofoundation.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

This prospective multicenter study will enroll 50 adult patients with acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only without biomechanical instability. Patients will be assessed at the baseline visit and subsequently be followed up at 3 and 6 months. All decisions regarding the treatment and clinical management will be left to the attending spinal surgeon and will follow the local standard of care. The core outcome assessments include: - Neurological status by the ISNCSCI - Patient-reported outcome measures (PROMs) of Short Form-36 (SF-36) v2 and Neuropathic Pain Scale (NPS) - The Spinal Cord Independence Measure (SCIM) v3 - Gait and balance evaluated using the ten-meter walk test (10mWT) and Walking Index for Spinal Cord Injury (WISCI) v2 - Upper extremity impairment evaluated using the grip strength with digital dynamometry, pinch strength (key pinch and tip-to-tip pinch), and the Partial Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) v2. All core outcome assessments will be performed at the baseline, 3-, and 6-month visits except for the PROMs, SCIM v3, key pinch and tip-to-tip pinch, which will be assessed only at the 3- and 6-month visits. The optional outcome assessment is the multiparametric quantitative spinal cord magnetic resonance imaging (MRI)/diffusion tensor imaging (DTI) which will be performed at baseline, 3-, and 6-month visits if it is done at the surgeon's discretion. The goal of this study is 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 with incomplete tetraplegia without spinal instability to capture the aspects of neurologic impairment that may not be well represented in the ISNCSCI examination.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Country Name City State
Brazil Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo São Paulo
Canada St. Michael's Hospital Toronto
Canada Toronto Western Hospital University Health Network Toronto
Canada Vancouver Spine Research Program, Blusson Spinal Cord Centre Vancouver
Germany BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau Murnau Am Staffelsee
India Indian Spinal Injuries Centre New Delhi
Portugal Orthopaedics, Centro Hospitalar Universitário do Porto Porto
United States UMD STC Neurosurgery Clinic Baltimore Maryland
United States Medical college of Winsconsine, Neurosurgery Milwaukee Wisconsin
United States San Francisco General Hospital San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
AO Foundation, AO Spine

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Germany,  India,  Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary Completion rate of the multiparametric quantitative spinal cord MRI/DTI Completion rate of the multiparametric quantitative spinal cord MRI/DTI up to 6 months
Primary 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
Primary Patient accrual rate Whether the patient drops out from the study, recorded at the time of dropout up to 6 months
Secondary Results from the core outcome assessment ISNCSCI Motor and sensory scores (motor score 0-100, pin prick score 0-112), AIS Grades, Clinical syndrome (Central Cord/Brown-Sequard/Anterior Cord/Conus Medullaris/Cauda Equina/No clinical syndrome/Not assessed) up to 6 months
Secondary Results from the core outcome assessment SF-36 v2 Eight scale scores (0-100): physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue or vitality, and general health perceptions up to 6 months
Secondary Results from the core outcome assessment Neuropathic pain score Score 0-100 up to 6 months
Secondary Results from the core outcome assessment SCIMv3 Three subscales: Self-care (0-20), Respiration and Sphincter Management (0-40), Mobility (room and toilet, 0-40) up to 6 months
Secondary Results from the core outcome assessment WISCI v2 Level of walking (score 0-20) up to 6 months
Secondary Results from the core outcome assessment Key pinch and tip-to-tip pinch Pinch strength in kg up to 6 months
Secondary Results from the core outcome assessment GRASSP v2 Eight subtest scores Strength (0-50), Palmar sensation (0-12), Prehension Ability (0-12), Prehension Performance (0-20) up to 6 months
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