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.
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.
Study Type
OBSERVATIONAL
Enrollment
35
Internal fixation system for surgical stabilisation of upper spine instabilities
Mater Misericordiae University Hospital
Dublin, Leinster, Ireland
RECRUITINGRadiographic 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.
Time frame: 24 months
Changes in Patient Reported Pain as Measured Using Visual Analogue Scale Score Throughout Follow up Period
At predetermined intervals (preoperative, at time of discharge and 6 weeks, 3 months, 6 months, 12 months and 24 months follow up), subjective patient pain will be recorded using the Visual Analogue Scale which ranges from 0 to 10 with a score of 10 indicating the most severe possible pain and a score of 0 indicating no pain is present. A secondary objective of this study is to prospectively gather patient reported outcomes (PROMs) in terms of pain and function
Time frame: 24 months
Changes in Patient Reported Function as Measured Using Short Form 12 Throughout Follow up Period
At predetermined intervals (preoperative, at time of discharge and 6 weeks, 3 months, 6 months, 12 months and 24 months follow up), subjective patient function will be recorded using the Short Form 12 which returns component scores representing both physical and mental status. These scores are adjusted and compare versus averages within the United States population. Both scores have an average score of 50 with a standard deviation of 10. Lower scores indicate worse function while higher scores indicate greater function.
Time frame: 24 months
Changes in Patient Reported Function as Measured Using Neck Disability Index Throughout Follow up Period
At predetermined intervals (preoperative, at time of discharge and 6 weeks, 3 months, 6 months, 12 months and 24 months follow up), subjective patient function will be recorded using the Neck Disability Index which ranges from 0 to 100 disability with a score of 100% indicating complete disability and a score of 0% indicating no disability is present.
Time frame: 24 months
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