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

NCT06816862 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

  • Cervical Instabilities Spine
  • Spine; Instability

Interventions

DEVICE

SYMPHONY™ OCT System

Internal fixation system for surgical stabilisation of upper spine instabilities

Sponsors & Collaborators

  • Mater Misericordiae University Hospital

    collaborator OTHER

  • University College Dublin

    lead OTHER

Principal Investigators

  • Joseph Butler, PhD · Mater Misericordiae University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816862 on ClinicalTrials.gov