The Viper Prime/Expedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime/Expedium spine system in minimally invasive and open surgeries, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, spondylolisthesis, trauma, and/or pseudarthrosis who require spine surgery under standard of care and use these implants. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.
Age ≥ 18 years
Have a radiograph-based diagnosis of degenerative disc disease, spondylolisthesis, spinal trauma (i.e., fracture or dislocation), spinal stenosis, or deformity (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, or pseudoarthrosis/failed fusion.
Pathology of the thoracolumbar or sacral spine.
Patients requiring fusion of 1-3 levels
Patients < 18 years
Patients with a cervical spine pathology
Patients with spinal tumors
Patients with bone density (DEXA) scores < 2.0 will be excluded.
Adult patients with spinal conditions mentioned in inclusion/exclusion criteria
Case-only
Prospective
Use of Viper Prime/Expedium system with Fibergraft BG Putty
DevicePatients who require spine surgery under standard of care and meet the inclusion and exclusion criteria identified, will be recruited from clinic. Consent for participation in study will be signed at the same time as consent for surgery. All PROMs and scans will be done as standard of care and data will be obtained through chart review for this study.
Fusion
We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.
Visual Analog Scale (VAS)
We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively
Oswestry Disability Index (ODI)
We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively
Short form survey-12
We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively
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