Trinity Elite in Lumbar Fusion

Degenerative Disc Disease Clinical Trial

Official title: A Prospective, Post Market, Multi-center, Open Label, Non-Randomized Clinical Study of the Efficacy of Using Trinity ELITE in Lumbar Fusion Surgery

Status Active, not recruiting

Clinical Trial Summary

This prospective, post-market, open label clinical study is designed to examine the lumbar fusion rate at 24 months post operative in subjects who have undergone a lumbar fusion surgery using Trinity Elite with or without local bone.

Clinical Trial Description

The study is a prospective, post-market, open label clinical study. Up to 10 sites across the United States, with a minimum enrollment of 120 subjects study-wide, will be enrolling subjects. The primary objective of this study is to measure the lumbar fusion rate in subjects at 24 months when lumbar arthrodesis is performed using Trinity Elite with or without local bone. Surgical approach (PLF, TLIF,ALIF, XLIF, etc.) is according to the physician's discretion, but must comply with FDA approved/cleared indication for use and labeling. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to Trinity ELITE. The secondary objectives of this study are to measure the clinical and economic outcomes when posterolateral arthrodesis is performed using Trinity Elite and/or local bone with supplemental pedicle screw fixation. ;

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

• NCT number: NCT02969616
• Study type: Observational
• Source: Orthofix Inc.
• Status: Active, not recruiting
• Start date: September 2016
• Completion date: July 2022