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Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD

Study acronym: FUSE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date changed from estimate of Jul 2025 to Jul 22, 2024v23
  2. Primary completion date: Jun 2025 to Jul 2025v22
  3. Primary completion date: Oct 2023 to Jun 2025v21 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 330 to 236
    • Study completion date: Dec 2023 to Dec 2025
    • Site details revised at 17 of 17 sites
  4. Re-verified, no change to tracked fieldsv20
  5. Study sites: 16 to 17v19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 15 to 16v18
  2. Study sites: 14 to 15v17
  3. Study sites: 13 to 14v16
  4. Study sites: 12 to 13v15
  5. Study sites: 11 to 12v14
  6. Site contacts updated at 3 of 11 sitesv13
  7. Study sites: 9 to 11v12
  8. Study sites: 8 to 9v11
  9. Study sites: 7 to 8v10
  10. Study sites: 6 to 7v9
  11. Study sites: 5 to 6v8
  12. Study sites: 4 to 5v7
  13. Study sites: 3 to 4v6
  14. Study sites: 2 to 3v5
  15. Study sites: 1 to 2v4
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2020 to Mar 18, 2020
    • Study description revised
    v3
  17. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will evaluate the safety and effectiveness of a device called "Posterior Cervical Stabilization System or PCSS" when used along with posterior cervical fusion (PCF) in combination with anterior cervical discectomy and fusion (ACDF) in the treatment of multi-level cervical degenerative disease.
Trial Details
NCT Number NCT04229017
Lead Sponsor Providence Medical Technology, Inc.
Conditions
(from sponsor)		 Degenerative Disc Disease
Related terms Intervertebral Disc Degeneration, Klippel-Feil Syndrome, Radiculopathy, Spinal Cord Diseases
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov