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

Recruitingn/aAges 18 Years - anyAllUniversity College Dublin
NCT06816862 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 instabilitie

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📋 Eligibility rules (as published)
Inclusion Criteria: * Consenting patients presenting for the treatment of acute and chronic instabilities of the craniocervical junction, the cervical and upper thoracic spine for whom the SYMPHONY OCT System is a suitable choice will be included in this study. * Patients undergoing surgical treatment for upper cervical spine traumatic spinal fractures and/or traumatic dislocations, failed previous fusions (pseudarthrosis) and tumours involving the cervical/thoracic spine will be included in this study. Exclusion Criteria: * Non-surgical candidates, patients with contraindications to surgery (e.g. severe medical comorbidities, known infection, etc.), * Patients with established osteoporosis * Long-term, systemic steroid use * Systemic diseases (e.g. rheumatoid arthritis, AIDS, HIV, etc.), * Patients unwilling or unable to give informed consent, or patients unwilling or unable to complete Health-related quality of (HRQOL) outcome life measures at the specified study time points pre- and post-operatively. * Subjects who have a history of drug or alcohol use that, in the opinion of the investigator would interfere with adherence to study requirements.
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What it tests

  • SYMPHONY™ OCT System
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Where

1 site
Mater Misericordiae University Hospital
Dublin, Ireland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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