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NCT06816862

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

Recruiting now Last updated 10 February 2025
What this trial tests

trial testing SYMPHONY™ OCT System in Cervical Instabilities Spine in 35 participants. Currently enrolling.

Timeline
1 December 2024
Primary endpoint
30 June 2026
30 June 2026

Quick facts

Lead sponsorUniversity College Dublin
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment35
Start date1 December 2024
Primary completion30 June 2026
Estimated completion30 June 2026
Sites1 location across Ireland

Drugs / interventions tested

Conditions studied

Sponsor

University College Dublin

Who can join

18 and older, any sex, with Cervical Instabilities Spine or Spine; Instability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other University College Dublin trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06816862.

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