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Degenerative Disc DiseaseNCT02969616

Trinity Elite in Lumbar Fusion

An observational study of Degenerative Disc Disease, run by Orthofix Inc..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Degenerative Disc Disease
What is being tested?
Trinity Elite
How many people
300 participants
Where
No sites listed yet
Study dates
Sep 2016to Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: age >= 18 years of age

Who may be able to join

  • Subject must be 18 years of age (≥ 18 years) or older at the time of consent.
  • 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
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  • Herniated nucleus pulposus
  • Facet joint degeneration/changes; and/or
  • Vacuum phenomenon
  • 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
  • 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.
  • 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.

Who cannot join

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

About this study

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

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.

Read the 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.

Being tested
Trinity Elite
Keywords
lumbar, fusion, DDD, Trinity Elite
Medical subject headings
Intervertebral Disc Degeneration, Dowling-Degos Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trinity EliteBiological

    cell based allograft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

  2. number of participants with treatment related adverse events

    AEs collected on an ongoing basis, reviewed by the Investigators and medical monitor

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionFeb 2022 (estimated)
  4. Study completionJul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02969616
Sponsor's protocol ID
CP-1504TEPL
Status last verified
Aug 2021
First submitted
15 Nov 2016
Last updated
11 Aug 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Lansford T, Park DK, Wind JJ, Nunley P, Peppers TA, Russo A, Hassanzadeh H, Sembrano J, Yoo J, Sales J. High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach. Int J Spine Surg. 2024 Sep 12;18(4):355-364. doi: 10.14444/8612.

    PubMed 39054302

  • Russo A, Park DK, Lansford T, Nunley P, Peppers TA, Wind JJ, Hassanzadeh H, Sembrano J, Yoo J, Sales J. Impact of surgical risk factors for non-union on lumbar spinal fusion outcomes using cellular bone allograft at 24-months follow-up. BMC Musculoskelet Disord. 2024 May 3;25(1):351. doi: 10.1186/s12891-024-07456-4.

    PubMed 38702654

  • Park DK, Wind JJ, Lansford T, Nunley P, Peppers TA, Russo A, Hassanzadeh H, Sembrano J, Yoo J, Sales J. Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion. BMC Musculoskelet Disord. 2023 Nov 17;24(1):895. doi: 10.1186/s12891-023-06996-5.

    PubMed 37978378

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease, run by Orthofix Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

lumbar fusion by CT scan following arthrodesis using Trinity Elite (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02969616, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021; AzTrials last refreshed its copy on 27 Oct 2026.

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