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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity College Dublin

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.),

Trial design

Treatments tested in this trial

  • SYMPHONY™ OCT System

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators

University College Dublin

Lead sponsor

Mater Misericordiae University Hospital

Collaborator