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

NCT06816862 | Recruiting FDA Device

• 1 other identifier: SYMPHONY™
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spine Fusion; Spine Fixation; Spine Surgery; Cervical Instabilities

Outcome Measures

Primary Outcomes (1)

• Radiographic Fusion at 24 months as inferred by Presence of Segmental Stability and Absence of Mechanical Failure on Xray/CT

  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.

  24 months

Secondary Outcomes (3)

• Changes in Patient Reported Pain as Measured Using Visual Analogue Scale Score Throughout Follow up Period

  24 months

• Changes in Patient Reported Function as Measured Using Short Form 12 Throughout Follow up Period

  24 months

• Changes in Patient Reported Function as Measured Using Neck Disability Index Throughout Follow up Period

  24 months

Study Arms (1)

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.

Device: SYMPHONY™ OCT System

Interventions

SYMPHONY™ OCT System DEVICE

Internal fixation system for surgical stabilisation of upper spine instabilities

SYMPHONY™ Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18 years or older) with acute/chronic upper spine instabilities requiring surgical intervention and stabilisation with instrumentation

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Dublin: lead
• Mater Misericordiae University Hospital: collaborator

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, Leinster, D07R2WY, Ireland

RECRUITING

Related Publications (6)

• Verla T, Xu DS, Davis MJ, Reece EM, Kelly M, Nunez M, Winocour SJ, Ropper AE. Failure in Cervical Spinal Fusion and Current Management Modalities. Semin Plast Surg. 2021 Feb;35(1):10-13. doi: 10.1055/s-0041-1722853. Epub 2021 May 10.

  PMID: 33994872 BACKGROUND

• Badiee RK, Mayer R, Pennicooke B, Chou D, Mummaneni PV, Tan LA. Complications following posterior cervical decompression and fusion: a review of incidence, risk factors, and prevention strategies. J Spine Surg. 2020 Mar;6(1):323-333. doi: 10.21037/jss.2019.11.01.

  PMID: 32309669 BACKGROUND

• Hilibrand AS, Fye MA, Emery SE, Palumbo MA, Bohlman HH. Impact of smoking on the outcome of anterior cervical arthrodesis with interbody or strut-grafting. J Bone Joint Surg Am. 2001 May;83(5):668-73. doi: 10.2106/00004623-200105000-00004.

  PMID: 11379735 BACKGROUND

• Lau D, Chou D, Ziewacz JE, Mummaneni PV. The effects of smoking on perioperative outcomes and pseudarthrosis following anterior cervical corpectomy: Clinical article. J Neurosurg Spine. 2014 Oct;21(4):547-58. doi: 10.3171/2014.6.SPINE13762. Epub 2014 Jul 11.

  PMID: 25014499 BACKGROUND

• Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009.

  PMID: 21093718 BACKGROUND

• Platt D, Platt M, Loffler H. [Cytochemical demonstration of beta-acetylglucosamindase in human blood- and bone marrow cells]. Klin Wochenschr. 1968 Jun 1;46(11):617-8. doi: 10.1007/BF01747843. No abstract available. German.

  PMID: 5726589 BACKGROUND

Study Officials

• Joseph Butler, PhD

  Mater Misericordiae University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jake McDonnell, MRCS

CONTACT

0852802958; jakemcdonnell@eril.ie

Joseph Butler, PhD

CONTACT

0877034291; josephsbutler@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)