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

Официальное название

Clinical/Radiologic Outcomes Associated With the SYMPHONY™ OCT System for Treatment of Acute and Chronic Instabilities of the Craniocervical Junction, the Cervical Spine and the Upper Thoracic Spine

Обзор

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.

Подробное описание

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. This study will follow patients undergoing posterior stabilisation of the upper spine using the SYMPHONY™ OCT system as an augment to fusion. This system consists of bone anchors (e.g. screws) for connection by longitudinal components (e.g. rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link longitudinal components for additional stability during fusion mass development.

In spine fusion procedures, bone is encouraged to grow in order to fuse vertebrae of the spine together to relieve pain or increase stability. The likelihood of a successful fusion is thought to be influenced by multiple factors. Patient-related factors influencing fusion success include comorbidities such as osteoporosis or osteopenia, diabetes, and obesity. Factors affecting the inflammatory response, such as rheumatoid arthritis or long-term steroid use may also increase the likelihood of fusion failure. Fusion success can also be influenced by age, frailty, functional status, history of smoking or steroid use.

Frailty is a clinically recognizable syndrome comprised of declining physiological reserve, characterized by decreased resilience to adverse health outcomes. Fried et al have defined frailty as meeting three out of five of the following criteria: low grip strength, low energy, slow walking speed, low physical activity, unintentional weight loss. The modified 5-item frailty index (mFI-5) is another method of measuring frailty commonly used in clinical settings. It has been shown to predict the occurrence of adverse outcomes following various orthopaedic surgeries. The five comorbidities included in the mFI-5 are a history of hypertension, COPD, diabetes mellitus, congestive heart failure, and a non-independent functional status.

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (3)

• Changes in Patient Reported Pain as Measured Using Visual Analogue Scale Score Throughout Follow up Period [Срок оценки: 24 months]
• Changes in Patient Reported Function as Measured Using Short Form 12 Throughout Follow up Period [Срок оценки: 24 months]
• Changes in Patient Reported Function as Measured Using Neck Disability Index Throughout Follow up Period [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Ирландия · 1 центр

• Mater Misericordiae University Hospital — Dublin

Публикации

• 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
• 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
• 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
• 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
• 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
• Walston J, Buta B, Xue QL. Frailty Screening and Interventions: Considerations for Clinical Practice. Clin Geriatr Med. 2018 Feb;34(1):25-38. doi: 10.1016/j.cger.2017.09.004. PMID 29129215

Идентификаторы

NCT: NCT06816862 · SYMPHONY™

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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