Trinity Elite in Lumbar Fusion

NCT02969616 | Unknown

• 1 other identifier: CP-1504TEPL
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Degenerative Disc Disease

Keywords

lumbar, fusion, DDD, Trinity Elite

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Trinity Elite BIOLOGICAL

cell based allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

age \>= 18 years of age

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• Subject requires supplemental interbody arthrodesis.
• Subject has an allergy to DMSO.
• Subject is a prisoner.

Sponsors & Collaborators

• Orthofix Inc.: lead

Related Publications (3)

• 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.

  PMID: 39054302 DERIVED

• 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.

  PMID: 38702654 DERIVED

• 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.

  PMID: 37978378 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Dowling-Degos Disease

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Alan Daniels, MD

  Brown University

  PRINCIPAL INVESTIGATOR

• Daniel Park, MD

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

• Fernando Techy, MD

  ClinTech Center for Spine Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 21, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 11, 2021

Record last verified: 2021-08