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Clinical Trials in Ireland / NCT06816862
Recruiting Observational

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

NCT06816862 · tracked via the Priya Life Science Ireland tracker
Sponsor
University College Dublin
Phase
Observational
Started
2024-12-01
Last updated
2025-02-10

Condition(s) studied

Cervical Instabilities SpineSpine; Instability

Investigational drug(s) / intervention(s)

SYMPHONY™ OCT System

SYMPHONY™ OCT System: Internal fixation system for surgical stabilisation of upper spine instabilities

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Radiographic Fusion at 24 months as inferred by Presence of Segmental Stability and Absence of Mechanical Failure on Xray/CT — 24 months
    The primary objective of this study is to evaluate the radiographic assessment of fusion at 24 months postoperatively. This radiographic assessment will consist of plain Xrays preoperatively, at 6 weeks, 3 months, 6 months and 24 months postoperatively. These will include a combination of anterior, lateral, flexion and extension views images of the spine used to infer stability. Fusion failure (pseudarthrosis) will be defined as signs of mechanical failure (such as peri-implant radiolucency/haloing, screw/rod fracture, etc.) or \<50% bridging trabecular bone on CT scan at 12 months postoperatively. Assessment of fusion will be conducted by a musculoskeletal radiologist and 2 independent fellowship trained spine surgeons.

Trial sites (1)

FacilityCityRegionStatus
Mater Misericordiae University Hospital Dublin Leinster Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06816862 on ClinicalTrials.gov ↗ ← All trials in Ireland