Clinical trial NCT02969616: Trinity Elite in Lumbar Fusion
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Disc Disease
Keywords: lumbar, fusion, DDD, Trinity Elite
Lead sponsor: Orthofix Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age \>= 18 years of age

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.

Eligibility criteria: 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.

Primary outcomes:
measure: lumbar fusion by CT scan following arthrodesis using Trinity Elite
timeFrame: 24 months
measure: number of participants with treatment related adverse events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brown University
name: Alan Daniels, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beaumont Hospital
name: Daniel Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ClinTech Center for Spine Health
name: Fernando Techy, MD
role: PRINCIPAL_INVESTIGATOR
References: