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.
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.
Study Type
OBSERVATIONAL
Enrollment
50
Cervical collar, Halo ring, Halo vest, cervical braces, skeletal skull traction, MAP, steroids, observation or bedrest
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
San Francisco General Hospital
San Francisco, California, United States
RECRUITINGUMD STC Neurosurgery Clinic
Baltimore, Maryland, United States
RECRUITINGMedical college of Winsconsine, Neurosurgery
Milwaukee, Wisconsin, United States
RECRUITINGInstituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo
São Paulo, Brazil
RECRUITINGSt. Michael's Hospital
Toronto, Canada
RECRUITINGToronto Western Hospital University Health Network
Toronto, Canada
RECRUITINGVancouver Spine Research Program, Blusson Spinal Cord Centre
Vancouver, Canada
RECRUITINGBG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau
Murnau am Staffelsee, Germany
RECRUITINGIndian Spinal Injuries Centre
New Delhi, India
RECRUITINGOrthopaedics, Centro Hospitalar Universitário do Porto
Porto, Portugal
RECRUITINGThe 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
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: up to 6 months
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
Time frame: 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
Time frame: up to 6 months
Patient accrual rate
Whether the patient drops out from the study, recorded at the time of dropout
Time frame: up to 6 months
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)
Time frame: up to 6 months
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
Time frame: up to 6 months
Results from the core outcome assessment Neuropathic pain score
Score 0-100
Time frame: up to 6 months
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)
Time frame: up to 6 months
Results from the core outcome assessment WISCI v2
Level of walking (score 0-20)
Time frame: up to 6 months
Results from the core outcome assessment Key pinch and tip-to-tip pinch
Pinch strength in kg
Time frame: up to 6 months
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)
Time frame: up to 6 months
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