Actively Recruiting
Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime
Led by Nitin Agarwal · Updated on 2026-01-22
100
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
Sponsors
N
Nitin Agarwal
Lead Sponsor
D
DePuy Synthes
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Radiograph-based diagnosis of degenerative disc disease, spondylolisthesis, spinal trauma, spinal stenosis, deformity, spinal tumor, or pseudoarthrosis/failed fusion
- Pathology affecting the thoracolumbar or sacral spine
- Need for fusion of 1 to 3 spinal levels
- Surgery and devices received as standard care prescribed by the treating physician
You will not qualify if you...
- Younger than 18 years
- Cervical spine pathology
- Presence of spinal tumors
- Bone density (DEXA) score less than 2.0
- Current smokers or quit smoking within 6 weeks prior to presentation
- Body mass index greater than 40 kg/m2
- Need for fusion involving more than 3 spinal levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
N
Nitin Agarwal, MD
CONTACT
R
Rida Mitha, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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