Trials / Recruiting
RecruitingNCT06704906
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Nitin Agarwal · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Spondylolisthesis, Lumbar Region
- Spinal Trauma With Neurological Deficit
- Degeneration of Lumbar Intervertebral Disc
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Use 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. |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2028-12-31
- Completion
- 2029-03-30
- First posted
- 2024-11-26
- Last updated
- 2026-01-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06704906. Inclusion in this directory is not an endorsement.