NCT02969616

Trinity Elite in Lumbar Fusion

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
BIOLOGICAL	Trinity Elite	cell based allograft

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-02-01
• Completion: 2022-07-01
• First posted: 2016-11-21
• Last updated: 2021-08-11