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Trinity Elite in Posterolateral Lumbar Fusion

2016-11-22 14:08:21 | BioPortfolio

Summary

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

Description

The study is a prospective, post-market, open label clinical study. Up to 10 sites across the United States, with a total enrollment of approximately 120 subjects, will be enrolling subjects. The primary objective of this study is to measure the posterolateral fusion rate at 24 months when posterolateral arthrodesis is performed using Trinity Elite with or without local bone and with supplemental pedicle screw fixation. The primary endpoints are radiographic evidence of posterolateral 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Degenerative Disc Disease

Intervention

Trinity Elite

Status

Enrolling by invitation

Source

Orthofix Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-22T14:08:21-0500

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