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Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease

Study acronym: SECOND
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures. The primary outcome measure is the rate of fusion success in the investigational treatment arm (ACDF + PCF) compared with the control arm (ACDF alone) at the 12-month follow-up visit. Researchers will compare the investigational treatment arm (ACDF + PCF) to the control arm (ACDF alone) to assess superiority in terms of fusion success rate.
Trial Details
NCT Number NCT07721493
Lead Sponsor Providence Medical Technology, Inc.
Conditions
(from sponsor)
Degenerative Disc Disease(DDD)
Related terms Intervertebral Disc Degeneration, Klippel-Feil Syndrome, Radiculopathy, Spinal Cord Diseases
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov