NCT04621799

Fibrin for Chronic Multi-level Discogenic Low Back Pain

A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Pauza, Kevin, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).

Detailed description

The purpose of this study is to analyze data available in the PIs Regenerative Orthobiologics Registry (ROR) and corresponding patient charts that will either support or refute the efficacy of Intra-annular fibrin as treatment for moderate to severe low back pain. Additionally, we seek to retrospectively identify possible predisposing factors that are correlated with positive outcomes with respect to patient-reported pain and function.

Conditions

• Low Back Pain
• Disc Disease
• Disc Degeneration
• Radiculopathy
• Annular Disc Tear

Interventions

Type	Name	Description
DRUG	Fibrin sealant	The intra-annular delivery of non-autologous fibrin into the annulus

Timeline

• Start date: 2018-06-11
• Primary completion: 2020-12-31
• Completion: 2021-06-30
• First posted: 2020-11-09
• Last updated: 2020-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study