Degenerative Disc DiseaseNCT00951938
Trinity Evolution in Anterior Cervical Disectomy and Fusion (ACDF)
An observational study of Degenerative Disc Disease, run by Orthofix Inc. at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease
- How many people
- 200 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2009to Aug 2012
- 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: Subject selection will be conducted by patient's neurosurgeon or orthopedic surgeon.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan, A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109-5338
Carolina NeuroSurgery & Spine
Charlotte, North Carolina, 28204
CORE Orthopaedic Medical Center
Encinitas, California, 92024
Kansas University Medical Center
Kansas City, Kansas, 66160
Western Regional Center for Spine and Brain Surgery
Las Vegas, Nevada, 89109
Central Connecticut Neurosurgery and Spine
New Britain, Connecticut, 28204
Denver-Vail Orthopedics, P.C.
Parker, Colorado, 80134
Jefferson Medical College
Philadelphia, Pennsylvania, 19107
Triangle Neurosurgery
Raleigh, North Carolina, 27607
Shasta Orthopaedics Spine Center
Redding, California, 96001
The Virginia Spine Institute
Reston, Virginia, 20190
Tuckahoe Orthopaedic Associates
Richmond, Virginia, 23226
Greater Houston Neurosurgery Center
The Woodlands, Texas, 77381
About this study
Official title: 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
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.
Read the detailed description
When conservative care fails to alleviate the pain and neurological deficits caused by degenerative disc disease in a cervical spine, the most common recourse is surgical decompression of the affected nerves and/or spinal cord. Decompression is often accomplished via an anterior approach whereby essentially the entire disc as well as any bony osteophytes and ligaments that are compressing the spinal cord and/or nerves are removed. While usually successful at decompressing affected neural structures, the decompression often results in collapse of the disc space, instability and recurrent symptomatology.
Most anterior cervical decompressions therefore are followed by insertion of a structural interbody spacer such as a bone graft from the patient's iliac crest (autograft) or a bone graft from a cadaver (allograft). The "gold standard" for aiding healing in spinal fusion surgeries is the harvesting of autograft from the patient's iliac crest and placing it in and around the segments of the spine that are intended to be fused. Autograft is considered the "gold standard" because it contains the essential elements required for successful bone grafting: osteogenesis, osteoconduction, and osteoinduction.
However, the morbidity of harvesting autograft has been well documented and includes chronic donor-site pain, infection, neurologic injury, blood loss, deformity, bowel injury, hernia, and prolonged surgical and hospitalization time. There are now a number of products on the market to minimize or replace the use of autograft. However, few of these products contain all three essential bone-forming elements (osteogenesis, osteoconduction, and osteoinduction) in a single, stand alone product.
Trinity Evolution is a novel, allogeneic cancellous bone matrix containing viable osteoprogenitor cells, mesenchymal stem cells and demineralized cortical bone (DCB) component to provide the required osteoconduction, osteogenesis, and osteoinduction necessary for successful bone grafting. Preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is considered an allograft and as such is a "minimally manipulated" tissue and is labeled for bone repair for spinal, orthopedic and podiatric indications where autograft is used. The dosage will be dependent upon the specific requirements of the case.
- Conditions
- Degenerative Disc Disease
- Keywords
- Trinity Evolution, Anterior Cervical Discectomy and Fusion, Allograft
- Medical subject headings
- Intervertebral Disc Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Rates for Trinity Evolution
Measured: Operative to 12 months Follow-up
Secondary outcomes (2)
NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
Measured: Pre-operative to 12 months follow-up
Complication Rates for Trinity Evolution
Measured: Operative to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond J Linovitz, MD, Study director, Orthofix Spinal Implants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951938
- Sponsor's protocol ID
- CP-01005A
- Status last verified
- Apr 2014
- First submitted
- 31 Jul 2009
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28446192
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00951938
- Acronym / sponsor ID
- CP-01005A
- Conditions
- Degenerative Disc Disease
- Keywords
- Trinity Evolution, Anterior Cervical Discectomy and Fusion, Allograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
When conservative care fails to alleviate the pain and neurological deficits caused by degenerative disc disease in a cervical spine, the most common recourse is surgical decompression of the affected nerves and/or spinal cord. Decompression is often accomplished via an anterior approach whereby essentially the entire disc as well as any bony osteophytes and ligaments that are compressing the spinal cord and/or nerves are removed. While usually successful at decompressing affected neural structures, the decompression often results in collapse of the disc space, instability and recurrent symptomatology.
Most anterior cervical decompressions therefore are followed by insertion of a structural interbody spacer such as a bone graft from the patient's iliac crest (autograft) or a bone graft from a cadaver (allograft). The "gold standard" for aiding healing in spinal fusion surgeries is the harvesting of autograft from the patient's iliac crest and placing it in and around the segments of the spine that are intended to be fused. Autograft is considered the "gold standard" because it contains the essential elements required for successful bone grafting: osteogenesis, osteoconduction, and osteoinduction.
However, the morbidity of harvesting autograft has been well documented and includes chronic donor-site pain, infection, neurologic injury, blood loss, deformity, bowel injury, hernia, and prolonged surgical and hospitalization time. There are now a number of products on the market to minimize or replace the use of autograft. However, few of these products contain all three essential bone-forming elements (osteogenesis, osteoconduction, and osteoinduction) in a single, stand alone product.
Trinity Evolution is a novel, allogeneic cancellous bone matrix containing viable osteoprogenitor cells, mesenchymal stem cells and demineralized cortical bone (DCB) component to provide the required osteoconduction, osteogenesis, and osteoinduction necessary for successful bone grafting. Preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is considered an allograft and as such is a "minimally manipulated" tissue and is labeled for bone repair for spinal, orthopedic and podiatric indications where autograft is used. The dosage will be dependent upon the specific requirements of the case.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject selection will be conducted by patient's neurosurgeon or orthopedic surgeon.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fusion Rates for Trinity Evolution
Time frame: Operative to 12 months Follow-up
2 secondary outcomes
NDI relative improvement, VAS improvement, Maintenance or improvement of neurological function
Time frame: Pre-operative to 12 months follow-up
Complication Rates for Trinity Evolution
Time frame: Operative to 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Derived from this study: PubMed 28446192Peppers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond J Linovitz, MD study director
Orthofix Spinal Implants
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by Orthofix Inc. at 13 sites in United States.
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 6 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: finished, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fusion Rates for Trinity Evolution (time frame: Operative to 12 months Follow-up). 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 NCT00951938, which also lists 1 linked publication.
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 8 Apr 2014.