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Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT

Degenerative Disc Disease Clinical Trial

Official title:
A Post-market, Prospective, Multi-center, Nonrandomized Study to Assess Posterolateral Lumbar Fusions Using FIBERGRAFT BG Matrix

Clinical Trial Summary

This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis requiring a fusion. The patient population will include adult (skeletally mature) men and women undergoing 1 or 2 level fusion in the lumbar spine (L2-S1) who are deemed eligible for the study, characterized by inclusion and exclusion criteria.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03884283
Study type Interventional
Source Prosidyan, Inc.
Contact
Status Completed
Phase N/A
Start date February 19, 2019
Completion date May 21, 2023
View Details
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