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NCT06704906 · ClinicalTrials.gov registry record
Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime
A clinical trial of Degeneration of Lumbar Intervertebral Disc and Spondylolisthesis, Lumbar Region, sponsored by Nitin Agarwal.
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT06704906: Recruiting study of Degeneration of Lumbar Intervertebral Disc and Spondylolisthesis, Lumbar Region, sponsored by Nitin Agarwal.
NCT06704906 is a study of Degeneration of Lumbar Intervertebral Disc and Spondylolisthesis, Lumbar Region that is actively recruiting participants, run by Nitin Agarwal. The registered enrollment target is 100 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06704906, a study of Degeneration of Lumbar Intervertebral Disc and Spondylolisthesis, Lumbar Region, is actively recruiting participants, sponsored by Nitin Agarwal.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
We will assess fusion with regular x-rays and CT scans at 1 and 2-year postoperatively.
Conditions Studied
Interventions
- DEVICE Use of Viper Prime/Expedium system with Fibergraft BG Putty
Study Locations (1)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-12-20 |
| Est. Completion | 2029-03-30 |
What NCT06704906 shows while recruiting
NCT06704906 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 3 conditions, with Degeneration of Lumbar Intervertebral Disc appearing as the primary indexed condition, and to 1 intervention - of which Use of Viper Prime/Expedium system with Fibergraft BG Putty is the first listed.
NCT06704906 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06704906 about?
NCT06704906 is a clinical study titled "Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty/Viper Prime". 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 ...
What is the current status of trial NCT06704906?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2024-12-20. Estimated completion is 2029-03-30.
What conditions does trial NCT06704906 study?
This clinical trial studies the following conditions: Degeneration of Lumbar Intervertebral Disc, Spondylolisthesis, Lumbar Region, Spinal Trauma With Neurological Deficit.
What interventions are being tested in trial NCT06704906?
The interventions under investigation include: Use of Viper Prime/Expedium system with Fibergraft BG Putty (DEVICE).
Who is sponsoring clinical trial NCT06704906?
This trial is sponsored by Nitin Agarwal, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06704906 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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