Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime

Assess Clinical and Radiographic Outcomes of VIPER PRIME/Expedium Spine System and Fibergraft BG Putty

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.

Study Overview

• Status: Recruiting
• Conditions: Degeneration of Lumbar Intervertebral Disc; Spondylolisthesis, Lumbar Region; Spinal Trauma With Neurological Deficit
• Intervention / Treatment: Device: Use of Viper Prime/Expedium system with Fibergraft BG Putty

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nitin Agarwal, MD; Phone Number: 9085311947; Email: nitin.agarwal@upmc.edu
• Study Contact Backup: Name: Rida Mitha, MD; Phone Number: 3147327092; Email: mithar@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Rida Mitha; Phone Number: 3147327092; Email: mithar@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with spinal conditions mentioned in inclusion/exclusion criteria

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
Oswestry Disability Index (ODI)	We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)
Short form survey-12	We will have patients fill out validated tools for PROs to assess how the patient is doing postoperatively	2 years (At baseline, postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months)

Collaborators and Investigators

• Sponsor: Nitin Agarwal
• Collaborators: DePuy Synthes
• Investigators: Principal Investigator: Nitin Agarwal, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 30, 2029

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: STUDY24040006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No