Outcomes for adults after spine surgery using Fibergraft and Viper Prime
Assess Clinical and Radiographic Outcomes of VIPER PRIME/Expedium Spine System and Fibergraft BG Putty
This study is testing if using a special bone healing putty with a new spine surgery system can help adults with spine problems recover better and avoid complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06704906 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical and radiographic outcomes of adult patients undergoing spine surgery for conditions such as spondylolisthesis and degenerative disc disease. Patients will receive the Viper Prime/Expedium spine system along with Fibergraft Bioactive Glass putty, which is designed to enhance the body's natural bone healing process. The study will follow participants for two years to assess fusion rates, complication rates, and the need for revision surgeries. This research addresses a gap in existing studies by specifically focusing on the outcomes associated with the combination of these implants.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific spinal conditions requiring fusion of 1-3 levels.
Not a fit: Patients with cervical spine pathology, spinal tumors, or those requiring fusion for more than 3 levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery for patients undergoing spine surgery.
How similar studies have performed: Previous studies have shown success with the Viper Prime/Expedium systems, but this specific combination with Fibergraft is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Nitin Agarwal, MD — University of Pittsburgh
- Study coordinator: Nitin Agarwal, MD
- Email: nitin.agarwal@upmc.edu
- Phone: 9085311947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.