Actively Recruiting
SYMPHONY™ OCT System for Instabilities of the Upper Thoracic and Cervical Spine
Led by University College Dublin · Updated on 2025-02-10
35
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
U
University College Dublin
Lead Sponsor
M
Mater Misericordiae University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SYMPHONY™ OCT System for Instabilities of the Upper Thoracic and Cervical Spine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consenting patients needing treatment for acute or chronic instabilities of the craniocervical junction, cervical, or upper thoracic spine suitable for SYMPHONY OCT System
- Patients undergoing surgery for traumatic fractures, dislocations, failed previous fusions, or tumors in the cervical/thoracic spine
You will not qualify if you...
- Patients not candidates for surgery or with contraindications to surgery such as severe medical conditions or infections
- Patients with established osteoporosis
- Patients using long-term systemic steroids
- Patients with systemic diseases like rheumatoid arthritis, AIDS, or HIV
- Patients unwilling or unable to consent or complete quality of life measures before and after surgery
- Patients with drug or alcohol use history that may interfere with study adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mater Misericordiae University Hospital
Dublin, Leinster, Ireland, D07R2WY
Actively Recruiting
Research Team
J
Jake McDonnell, MRCS
CONTACT
J
Joseph Butler, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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