Incomplete Cervical SCI Without Instability

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• The proportion of the core outcome assessments successfully completed at each visit — up to 6 months
  For baseline and each FU visit, the completion status of each core outcome assessment
• Time required to complete the individual core outcome assessments — up to 6 months
  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)
• Total time required to complete all core outcome assessments at each visit — up to 6 months
  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).
• Completion rate of individual core outcome assessments (and their scorings if applicable) — up to 6 months
  Completion rate of individual core outcome assessments at each visit.
• Completion rate of the multiparametric quantitative spinal cord MRI/DTI — up to 6 months
  Completion rate of the multiparametric quantitative spinal cord MRI/DTI
• FU visit compliance rate and reasons for non-compliance — up to 6 months
  Completion status of FU visits, recorded at 3- and 6-month visits
• Patient accrual rate — up to 6 months
  Whether the patient drops out from the study, recorded at the time of dropout

Trial sites (10)

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