Degeneration of Lumbar Intervertebral Disc, Spinal Trauma With Neurological Deficit, Spondylolisthesis, Lumbar Region
Conditions
Brief summary
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.
Interventions
DEVICEUse of Viper Prime/Expedium system with Fibergraft BG Putty
Patients 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.
Sponsors
Nitin Agarwal
DePuy Synthes
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. 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. 3. Pathology of the thoracolumbar or sacral spine. 4. Patients requiring fusion of 1-3 levels 5. Patients receiving the surgery/devices as standard of care prescribed by the treating physician.
Exclusion criteria
1. Patients \< 18 years 2. Patients with a cervical spine pathology 3. Patients with spinal tumors 4. Patients with bone density (DEXA) scores \< 2.0 will be excluded. 5. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded. 6. Patients with a BMI \> 40kg/m2 7. Patients requiring fusion for more than 3 levels will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion | 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months) | We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months) | We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively |
| Oswestry Disability Index (ODI) | 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months) | We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively |
| Short form survey-12 | 2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months) | We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively |
Countries
United States
Contacts
CONTACTNitin Agarwal, MD
CONTACTRida Mitha, MD
PRINCIPAL_INVESTIGATORNitin Agarwal, MD
University of Pittsburgh
Outcome results
None listed