Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
TLF
A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells (Trinity Evolution™ Viable Cryopreserved Cellular Bone Matrix) in Posterior Lumbar or Transforaminal Lumbar Interbody Fusion (PLIF or TLIF)
1 other identifier
observational
207
1 country
15
Brief Summary
The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will result in fusion rates and clinical outcomes similar to those with other routinely used autograft and allograft materials including: fusion, improvement in pain and function, maintenance of lower extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2009
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedOctober 23, 2018
October 1, 2018
5.2 years
August 21, 2009
October 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fusion Rates for Trinity Evolution
Operative to 24 months follow-up
Secondary Outcomes (2)
NDI relative improvement; VAS improvement; Maintenance or improvement of neurological function
Pre-op to 24 months follow-up
Complication Rates for Trinity Evolution
Operative to 24 months
Eligibility Criteria
Patients with symptomatic lumbar degenerative disc disease scheduled to undergo PLIF or TLIF.
You may qualify if:
- Symptomatic lumbar degenerative disc disease at 1 or 2 adjacent levels between L3 and S1
- Patients with back and/or leg pain scheduled for stabilization with or without decompression via a TLIF or PLIF approach utilizing an interbody spacer and supplemental posterior fixation.
- Greater than 18 years of age
- Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
- Willing and able to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent.
You may not qualify if:
- Patients requiring surgical treatment other than at 1 or 2 adjacent levels between L3 and S1
- Active local or systemic infection
- Currently pregnant or considering becoming pregnant during the follow-up period
- Active malignancy or having been on chemotherapy of any kind for a malignancy in the past 1 year
- Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution matrix in and around the interbody spacer.
- Use of adjunctive post-operative stimulation
- Prior interbody surgery at the same level
- Has a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orthofix Inc.lead
Study Sites (15)
Boulder Neurosurgical Associates
Boulder, Colorado, 80304, United States
Total Spine Care
Canton, Connecticut, 06019, United States
Middlesex Orthopedic Surgeons
Middletown, Connecticut, 06457, United States
Center for Advanced Neuro and Spine
New Britain, Connecticut, 06051, United States
Optim Healthcare (Formerly Southeastern Orthopedic Center)
Savannah, Georgia, 31405, United States
Parkview Orthopaedic Group
Palos Heights, Illinois, 60463, United States
Willis Knighton Health System
Shreveport, Louisiana, 71105, United States
University of Michigan A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109, United States
Cooper University Neurological Institute
Camden, New Jersey, 08103, United States
Spine Surgery of Buffalo Niagara
Niagara Falls, New York, 14304, United States
Carolina NeuroSurgery & Spine
Charlotte, North Carolina, 28204, United States
Triangle Orthopaedic Associates
Durham, North Carolina, 27704, United States
Duke University
Durham, North Carolina, 27710, United States
Triangle Neurosurgery
Raleigh, North Carolina, 27607, United States
Tuckahoe Orthopedic Surgeons
Richmond, Virginia, 23226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James T Ryaby, PhD
Orthofix Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2009
First Posted
August 25, 2009
Study Start
September 1, 2009
Primary Completion
November 1, 2014
Study Completion
January 1, 2015
Last Updated
October 23, 2018
Record last verified: 2018-10