Clinical/Radiologic Outcomes Associated with the SYMPHONY™ OCT System for Treatment of Acute and Chronic Instabilities of the Craniocervical Junction, the Cervical Spine and the Upper Thoracic Spine

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ireland
Mater Misericordiae University Hospital
RECRUITING
Dublin
Contact Information
Primary
Jake McDonnell, MRCS
jakemcdonnell@eril.ie
0852802958
Backup
Joseph Butler, PhD
josephsbutler@gmail.com
0877034291
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 35
Treatments
SYMPHONY™ Cohort
This cohort is composed of patients who will be prospectively enrolled (35 total). These patients will undergo upper spinal stabilisation supplemented with internal fixation using the SYMPHONY™ OCT system indicated for acute and chronic upper spinal instabilities. This device is FDA approved thus this is post market observational intervention. This trial was a target follow up of 2 years for each participant.
Related Therapeutic Areas
Sponsors
Leads: University College Dublin
Collaborators: Mater Misericordiae University Hospital

This content was sourced from clinicaltrials.gov