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Incomplete Cervical SCI Without Instability

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 7 entries Show 6 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Aug 18, 2027 to Aug 18, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Site details revised at 1 of 10 sites
    • Study description expanded, about 5 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: May 1, 2026 to Aug 15, 2026
    • Study completion date: Aug 1, 2027 to Aug 18, 2027
    • Site details revised at 10 of 10 sites
    v15
  3. Eligibility criteria revisedv14
  4. Re-verified, no change to tracked fieldsv13
  5. Site details revised at 1 of 10 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: May 1, 2025 to May 1, 2026
    • Study completion date: May 1, 2025 to Aug 1, 2027
    v11
  2. Site details revised at 3 of 10 sitesv10
  3. Study sites: 11 to 10v9
  4. Site details revised at 2 of 11 sitesv8
  5. Site details revised at 2 of 11 sitesv7
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 30, 2023 to Dec 11, 2023
    • Site details revised at 11 of 11 sites
    v6
  7. Start date: Sep 1, 2023 to Nov 30, 2023v5
  8. Start date: May 1, 2023 to Sep 1, 2023v4
  9. Start date: Feb 1, 2023 to May 1, 2023v3
  10. Primary endpoints revised (7)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05653206
Lead Sponsor AO Foundation, AO Spine
Conditions
(from sponsor)		 Cervical Spinal Cord Injury
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov