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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Biological: Trinity Elite

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 Type: Observational
• Enrollment (Anticipated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

age >= 18 years of age

Description

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.

7. 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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lumbar fusion by CT scan following arthrodesis using Trinity Elite	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	24 months
number of participants with treatment related adverse events	AEs collected on an ongoing basis, reviewed by the Investigators and medical monitor	24 months

Collaborators and Investigators

• Sponsor: Orthofix Inc.
• Investigators: Principal Investigator: Alan Daniels, MD, Brown University; Principal Investigator: Daniel Park, MD, Beaumont Hospital; Principal Investigator: Fernando Techy, MD, ClinTech Center for Spine Health

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ANTICIPATED): February 1, 2022
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (ESTIMATE): November 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: lumbar, fusion, DDD, Trinity Elite
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CP-1504TEPL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED