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SYMPHONY™ OCT System for Instabilities of the Upper Thoracic and Cervical Spine

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated February 10, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
This will be a prospective, multi-centre study at a National Tertiary Referral Centre for spinal trauma and spinal cord injuries, serving a catchment area of 5 million people. Consecutive patients undergoing posterior-only surgery or combined anterior and posterior surgery for degenerative cervical pathology, traumatic spinal fractures or dislocations, failed previous fusions or treatment for tumour involving the cervical/thoracic spine will be enrolled. This is a post-market trial, with a CE-marked medical device called the SYMPHONY OCT System which is currently in use in both centres. The SYMPHONY™ OCT System is a portfolio of internal fixation tools including screw, rods and hooks used as an adjunct to fusion for posterior stabilisation of the upper spine in skeletally mature patients. This pilot study hypothesizes that the use of SYMPHONY™ OCT System to treat upper spine instabilities will achieve results comparable to historical cases using the Mountaineer performed until 2021.
Trial Details
NCT Number NCT06816862
Lead Sponsor University College Dublin
Collaborators: Mater Misericordiae University Hospital
Conditions
(from sponsor)		 Cervical Instabilities Spine, Spine; Instability
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov