Condition: Cervical Instabilities Spine · Spine; Instability · Sponsor: University College Dublin
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.
This description comes directly from the study's public registry record.
Jake McDonnell, MRCS · 0852802958 · jakemcdonnell@eril.ie
Joseph Butler, PhD · 0877034291 · josephsbutler@gmail.com
Always discuss trial participation with your own doctor first.
| Mater Misericordiae University Hospital | Dublin, Leinster, Ireland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06816862