Trinity Elite in Lumbar Fusion

• Conditions: Degenerative Disc Disease

• Registration Number: NCT02969616
• Lead Sponsor: Orthofix Inc.

Brief 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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-11
• Primary Completion: 2022-02
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Subject must be 18 years of age (≥ 18 years) or older at the time of consent.

2. Subject must have a documented diagnosis of DDD. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:

   • Instability as defined by >3mm translation or >5 degrees angulation
   • Osteophyte formation of facet joints or vertebral endplates
   • Decreased disc height, on average by >2mm, but dependent upon the spinal level
   • Scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule
   • Herniated nucleus pulposus
   • Facet joint degeneration/changes; and/or
   • Vacuum phenomenon

3. Subject may have up to a Grade 2 Spondylolisthesis of the lumbar spine with clinical manifestations of one or more of the following phenomena:

   • Radiculopathy
   • Sensory deficit
   • Motor weakness
   • Reflex changes

4. Subject must require lumbar arthrodesis at 1-4 contiguous levels (L1-S1) for a PLF approach and 1-2 contiguous levels for an interbody approach.

5. Subject must have been unresponsive to conservative care for at least 6 months prior to fusion surgery.

6. Subject must agree not to use electromagnetic adjuncts to enhance bone fusion during the course of the study 8. Subject must be willing and able to sign an informed consent document. 9. Subject must be willing and able to return for all follow-up visits, agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen.

Exclusion Criteria

1. Subject is under 18 years of age (<18) at the time of consent
2. Subject has had prior lumbar spine fusion surgery at any level
3. Subject has greater than grade 2 spondylolisthesis of the lumbar spine
4. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy in the past 5 years (benign skin cancer is permitted)
5. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis
6. Subject has an active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection
7. Subject requires supplemental interbody arthrodesis.
8. Subject has an allergy to DMSO.
9. Subject is a prisoner.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lumbar fusion by CT scan following arthrodesis using Trinity Elite	24 months	CT scan of the lumbar vertebral column will be used to determine the fusion status of the spine after Trinity Elite was used in the lateral gutters and in the facet joints. The number of bridging bony cortices will be recorded by blinded reviewers and tabulated. The data will be reported as n
number of participants with treatment related adverse events	24 months	AEs collected on an ongoing basis, reviewed by the Investigators and medical monitor