Degenerative Disc DiseaseTLFNCT00965380
Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
An observational study of Degenerative Disc Disease, run by Orthofix Inc. at 15 sites in United States.
Trial 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. 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
- 207 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2009to Jan 2015
- 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: Patients with symptomatic lumbar degenerative disc disease scheduled to undergo PLIF or TLIF.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, 48109
Boulder Neurosurgical Associates
Boulder, Colorado, 80304
Cooper University Neurological Institute
Camden, New Jersey, 08103
Total Spine Care
Canton, Connecticut, 06019
Carolina NeuroSurgery & Spine
Charlotte, North Carolina, 28204
Triangle Orthopaedic Associates
Durham, North Carolina, 27704
Duke University
Durham, North Carolina, 27710
Middlesex Orthopedic Surgeons
Middletown, Connecticut, 06457
Center for Advanced Neuro and Spine
New Britain, Connecticut, 06051
Spine Surgery of Buffalo Niagara
Niagara Falls, New York, 14304
Parkview Orthopaedic Group
Palos Heights, Illinois, 60463
Triangle Neurosurgery
Raleigh, North Carolina, 27607
Tuckahoe Orthopedic Surgeons
Richmond, Virginia, 23226
Optim Healthcare (Formerly Southeastern Orthopedic Center)
Savannah, Georgia, 31405
Willis Knighton Health System
Shreveport, Louisiana, 71105
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 Posterior Lumbar or Transforaminal Lumbar Interbody Fusion (PLIF or TLIF)
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.
Read the detailed description
Degenerative disorders of the lumbar spine can lead to a multitude of clinical problems including back pain and/or leg pain secondary to nerve compression and/or deformity. When conservative (non-surgical) treatment fails after at least a 6 month period and/or non-operative treatment is not indicated, patients and physicians may turn to a surgical solution. Surgical options consist basically of decompressing nerves, correcting and/or stabilizing deformities if required and fusing the segment, depending on the clinical situation. 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 a 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, Symptomatic lumbar degenerative disc disease, Posterior lumbar interbody fusion, Transforaminal lumbar interbody fusion
- 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 24 months follow-up
Secondary outcomes (2)
NDI relative improvement; VAS improvement; Maintenance or improvement of neurological function
Measured: Pre-op to 24 months follow-up
Complication Rates for Trinity Evolution
Measured: Operative to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James T Ryaby, PhD, Study director, Orthofix Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965380
- Sponsor's protocol ID
- CP-01006B
- Acronym
- TLF
- Status last verified
- Oct 2018
- First submitted
- 21 Aug 2009
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. 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 Posterior Lumbar or Transforaminal Lumbar Interbody Fusion (PLIF or TLIF)
- ClinicalTrials.gov ID
- NCT00965380
- Acronym / sponsor ID
- TLF / CP-01006B
- Conditions
- Degenerative Disc Disease
- Keywords
- Trinity Evolution, Symptomatic lumbar degenerative disc disease, Posterior lumbar interbody fusion, Transforaminal lumbar interbody fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 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 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.
Detailed description
Degenerative disorders of the lumbar spine can lead to a multitude of clinical problems including back pain and/or leg pain secondary to nerve compression and/or deformity. When conservative (non-surgical) treatment fails after at least a 6 month period and/or non-operative treatment is not indicated, patients and physicians may turn to a surgical solution. Surgical options consist basically of decompressing nerves, correcting and/or stabilizing deformities if required and fusing the segment, depending on the clinical situation. 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 a 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
- Patients with symptomatic lumbar degenerative disc disease scheduled to undergo PLIF or TLIF.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
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 24 months follow-up
2 secondary outcomes
NDI relative improvement; VAS improvement; Maintenance or improvement of neurological function
Time frame: Pre-op to 24 months follow-up
Complication Rates for Trinity Evolution
Time frame: Operative to 24 months
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 23 Oct 2018.
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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.
James T Ryaby, PhD study director
Orthofix Inc.
15 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 15 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 8 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 24 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2018.