Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)
A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells (Trinity Evolution™ Viable Cryopreserved Cellular Bone Matrix) in Patients Undergoing Anterior Cervical Discectomy and Fusion
1 other identifier
observational
200
1 country
13
Brief Summary
The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental anterior 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 anterior 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 upper 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 Aug 2009
Typical duration for all trials
13 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
July 31, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedFirst Posted
Study publicly available on registry
August 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedApril 8, 2014
April 1, 2014
3 years
July 31, 2009
April 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fusion Rates for Trinity Evolution
Operative to 12 months Follow-up
Secondary Outcomes (2)
NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
Pre-operative to 12 months follow-up
Complication Rates for Trinity Evolution
Operative to 12 months follow-up
Eligibility Criteria
Subject selection will be conducted by patient's neurosurgeon or orthopedic surgeon.
You may qualify if:
- Symptomatic cervical degenerative disc disease at up to four levels between C3 and T1
- Neck and/or arm pain and/or a functional neurological deficit, and/or cervical myelopathy with neural compression confirmed by plain x-rays and MRI, Myelogram or CT. Scheduled for an ACDF with a spacer and anterior supplemental fixation of the surgeon's choice.
- Greater than 18 years of age
- Unresponsive to conservative care over a period of at least 6 weeks 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:
- More than 4 levels (C3 - T1) requiring surgical treatment
- 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.
- Axial neck pain as the primary diagnosis, without evidence of neural compression
- Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution 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 (13)
CORE Orthopaedic Medical Center
Encinitas, California, 92024, United States
Shasta Orthopaedics Spine Center
Redding, California, 96001, United States
Denver-Vail Orthopedics, P.C.
Parker, Colorado, 80134, United States
Central Connecticut Neurosurgery and Spine
New Britain, Connecticut, 28204, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
University of Michigan, A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109-5338, United States
Western Regional Center for Spine and Brain Surgery
Las Vegas, Nevada, 89109, United States
Carolina NeuroSurgery & Spine
Charlotte, North Carolina, 28204, United States
Triangle Neurosurgery
Raleigh, North Carolina, 27607, United States
Jefferson Medical College
Philadelphia, Pennsylvania, 19107, United States
Greater Houston Neurosurgery Center
The Woodlands, Texas, 77381, United States
The Virginia Spine Institute
Reston, Virginia, 20190, United States
Tuckahoe Orthopaedic Associates
Richmond, Virginia, 23226, United States
Related Publications (1)
Peppers TA, Bullard DE, Vanichkachorn JS, Stanley SK, Arnold PM, Waldorff EI, Hahn R, Atkinson BL, Ryaby JT, Linovitz RJ. Prospective clinical and radiographic evaluation of an allogeneic bone matrix containing stem cells (Trinity Evolution(R) Viable Cellular Bone Matrix) in patients undergoing two-level anterior cervical discectomy and fusion. J Orthop Surg Res. 2017 Apr 26;12(1):67. doi: 10.1186/s13018-017-0564-5.
PMID: 28446192DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raymond J Linovitz, MD
Orthofix Spinal Implants
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2009
First Posted
August 4, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
April 8, 2014
Record last verified: 2014-04