Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
50 participants
OBSERVATIONAL
2023-12-11
2027-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neurologic Complications in Spinal Deformity Surgery - Extension
NCT02949245
Upper Extremity Surgery in Spinal Cord Injury
NCT01899664
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
NCT05638191
Supporting Patient Decisions About UE Surgery in Cervical SCI
NCT03464409
Testing the Decision Aid: Supporting Patient Decisions About Upper Extremity Surgery in Cervical SCI
NCT04995796
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AO Foundation, AO Spine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jefferson Wilson
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IN-TWIN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.