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Trinity Elite in Lumbar Fusion

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ClinicalTrials.gov Identifier: NCT02969616
Recruitment Status : Active, not recruiting
First Posted : November 21, 2016
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Degenerative Disc Disease 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : September 2016
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: Trinity Elite
    cell based allograft


Primary Outcome Measures :
  1. lumbar fusion by CT scan following arthrodesis using Trinity Elite [ Time Frame: 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

  2. number of participants with treatment related adverse events [ Time Frame: 24 months ]
    AEs collected on an ongoing basis, reviewed by the Investigators and medical monitor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
age >= 18 years of age
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969616


Sponsors and Collaborators
Orthofix Inc.
Investigators
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Principal Investigator: Alan Daniels, MD Brown University
Principal Investigator: Daniel Park, MD Beaumont Hospital
Principal Investigator: Fernando Techy, MD ClinTech Center for Spine Health
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Responsible Party: Orthofix Inc.
ClinicalTrials.gov Identifier: NCT02969616    
Other Study ID Numbers: CP-1504TEPL
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Orthofix Inc.:
lumbar, fusion, DDD, Trinity Elite
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases