Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 1 month later Aug 2026 → Oct 2028
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Record History

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  1. Primary and study completion pushed from Aug 2026 to Oct 2028
    • Eligibility criteria expanded, about 11 words
    • Publications: details revised at 6 of 6 entries
  2. Primary and study completion dates: Aug 2025 to Aug 2026
    • Site contact updated
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Primary and study completion dates: Aug 2023 to Aug 2025
    • Site contact updated
    v5
  5. Start date changed from estimate of Sep 2019 to Sep 1, 2019
    • Eligibility criteria shortened, about 4 words
    v4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Aug 2019 to Sep 2019
    v3
  2. Study description shortened, about 8 wordsv2
  1. Study First Submitted
  • 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.
This is a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Data will be collected from medical records for up to 730 days after surgery. Data to be collected will be demographic, preoperative clinical information, surgical details, and radiographic information. Patients will also undergo a non-standard of care CT scan 2 years after surgery.
Trial Details
NCT Number NCT04041583
Lead Sponsor Ohio State University
Collaborators: Medtronic
Conditions
(from sponsor)		 Cervical Fusion
Related terms Klippel-Feil Syndrome
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov