Tibiotalar ArthrodesisTAFNCT00988338
Evaluation of Trinity Evolution in Patients Undergoing Foot and Ankle Fusion
An observational study of Tibiotalar Arthrodesis and Subtalar Arthrodesis, run by Orthofix Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibiotalar Arthrodesis, Subtalar Arthrodesis, Calcaneocuboid Arthrodesis
- What is being tested?
- Trinity Evolution
- How many people
- 106 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2009to Jan 2013
- 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 determined by orthopedic surgeon.
Who may be able to join
- Foot and/or ankle pathology requiring fusion using open surgical technique with supplemental bone graft/substitute requiring one of the following procedures:
- Ankle joint fusion
- Subtalar fusion
- Calcaneocuboid fusion
- Talonavicular fusion
- Double fusions (talonavicular and calcaneocuboid joints)
Show all 10Show fewer
- Triple fusions (subtalar, talonavicular, and calcaneocuboid joints)
- At least 18 years of age
- 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
- Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution at the time of surgery
- Use of adjunctive post-operative stimulation
- 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
- Immunosuppressive therapy of any kind within the past 1 year
- Has a known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New Mexico Orthopedics
Albuquerque, New Mexico, 87106
Sinai Hospital of Baltimore / Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, 21215
Franciscan Foot and Ankle Specialists
Burien, Washington, 98166
OrthoCarolina Research Institute
Charlotte, North Carolina, 28203
Duke University Medical Center
Durham, North Carolina, 27710
Orthopaedic Associates of South Broward, PA
Hollywood, Florida, 33021
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Central Tennessee Foot and Ankle Center
Sparta, Tennessee, 38583
University Orthopedics Center
State College, Pennsylvania, 16801
Ohio Orthopedic Center of Excellence
Upper Arlington, Ohio, 43220
About this study
Official title: A Radiographic and Clinical Study Evaluating a Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem Cells (Trinity Evolution Matrix) in Subjects Undergoing Foot and Ankle Fusion
The purpose of this study is to utilize Trinity Evolution as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.
Read the detailed description
Symptomatic arthritic conditions of the foot and ankle including osteoarthritis, post-traumatic arthritis, inflammatory arthropathies and others can be painful and disabling conditions that lead to a reduced quality of life. Major symptoms include pain, stiffness, swelling, and difficulty walking. Many patients may be initially treatable with non-invasive measures such as analgesics, ankle-foot orthosis, physical therapy and medications such as steroids; however, over time, surgery becomes necessary to improve quality of life and maintain function. Arthrodesis is a well-known procedure that can reduce pain and result in a foot/ankle that can withstand an active lifestyle.
Bone graft is used to stimulate new bone formation at the operative site by providing osteogenic cells with osteoinductive factors with an osteoconductive matrix. Although autologous bone is often used as the structural graft material for fusion procedures, donor site morbidity (e.g., pain, infection, and fracture), limited supply, and inconsistent osteogenic activity continue to be associated problems. The quality of an autograft is dependent upon the age and medical condition of the patient, as well as the number of viable mesenchymal and osteoprogenitor stem cells that are present in the specimen. This tissue is harvested during the surgical procedure; the process can prolong morbidity at the harvest site. The ideal bone graft would offer osteogenic cells, osteoinductive factors, and an osteoconductive matrix with a consistent supply of viable mesenchymal stem cells (MSCs) and osteoprogenitor cells (OPCs)-but without the morbidity of autograft.
Due to the limitations associated with autograft, researchers are pursuing the use of bone-graft substitutes to promote arthrodesis. Bone-graft substitutes now being used by surgeons include ceramic synthetics, bone morphogenic proteins (BMPs), demineralized bone matrices (DBMs) and other allografts; these may be used alone or in combination. Allografts available as substitutes for autograft offer some of the benefits of autograft without its limitations-but do not contain viable MSCs and OPCs.
Trinity Evolution is an allogeneic cancellous bone matrix containing demineralized cortical bone (DCB) as well as viable osteoprogenitor and mesenchymal stem cells. Adult mesenchymal stem cells and osteoprogenitor cells, such as those in Trinity Evolution, are the precursor cells that differentiate into osteoblasts-the cells responsible for bone growth and repair.
Trinity Evolution provides the required osteoconduction, osteogenesis, and osteoinductivity necessary for successful bone grafting. It offers viable osteoprogenitor and mesenchymal stem cells and demineralized cortical bone-all in a single product. Data from preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is a "minimally manipulated" tissue that is considered an allograft, and as such, is labeled for bone repair for all orthopedic and podiatric indications where autograft is used. In this study, Trinity Evolution will be used as a substitute for autograft and/or standard allograft in the following arthrodesis procedures: tibiotalar, subtalar, calcaneocuboid, talonavicular, double fusions (i.e. calcaneocuboid and talonavicular), and triple fusions (i.e. subtalar, calcaneocuboid, and talonavicular).
- Conditions
- Tibiotalar Arthrodesis, Subtalar Arthrodesis, Calcaneocuboid Arthrodesis, Talonavicular Arthrodesis, Double Arthrodesis (i.e. Calcaneocuboid and Talonavicular), Triple Arthrodesis (i.e. Subtalar, Calcaneocuboid, and Talonavicular)
- Being tested
- Trinity Evolution
- Keywords
- Trinity Evolution, Arthrodesis, Foot Fusion, Ankle Fusion, Allograft
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trinity EvolutionBiological
Also called Allograft, Mesenchymal Stem Cells
Novel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem and Osteoprogenitor Cells
| Study group | Role | What they receive |
|---|---|---|
| Trinity Evolution | Not described Receives: Biological: Trinity Evolution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Success
Measured: 12 months
Secondary outcomes (1)
Improvement in scores: Ankle-Hindfoot Scale (AHS), Visual Analog Scale (VAS), and Health Survey (SF-36v2).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibiotalar ArthrodesisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 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 Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988338
- Sponsor's protocol ID
- TY01AF
- Acronym
- TAF
- Status last verified
- Oct 2021
- First submitted
- 29 Sep 2009
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. 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 Matrix) in Subjects Undergoing Foot and Ankle Fusion
- ClinicalTrials.gov ID
- NCT00988338
- Acronym / sponsor ID
- TAF / TY01AF
- Conditions
- Tibiotalar Arthrodesis, Subtalar Arthrodesis, Calcaneocuboid Arthrodesis, Talonavicular Arthrodesis, Double Arthrodesis (i.e. Calcaneocuboid and Talonavicular), Triple Arthrodesis (i.e. Subtalar, Calcaneocuboid, and Talonavicular)
- Keywords
- Trinity Evolution, Arthrodesis, Foot Fusion, Ankle Fusion, Allograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Oct 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 as a graft source in foot/ankle fusions and to follow the subjects to measure the clinical outcomes and fusion rate. The hypothesis of the study is that Trinity Evolution will result in fusion rates and clinical outcomes similar to those obtained from autograft and other routinely used allograft materials; these include: fusion, improvement in pain, improvement in function, and absence of adverse events related to the use of the graft source.
Detailed description
Symptomatic arthritic conditions of the foot and ankle including osteoarthritis, post-traumatic arthritis, inflammatory arthropathies and others can be painful and disabling conditions that lead to a reduced quality of life. Major symptoms include pain, stiffness, swelling, and difficulty walking. Many patients may be initially treatable with non-invasive measures such as analgesics, ankle-foot orthosis, physical therapy and medications such as steroids; however, over time, surgery becomes necessary to improve quality of life and maintain function. Arthrodesis is a well-known procedure that can reduce pain and result in a foot/ankle that can withstand an active lifestyle.
Bone graft is used to stimulate new bone formation at the operative site by providing osteogenic cells with osteoinductive factors with an osteoconductive matrix. Although autologous bone is often used as the structural graft material for fusion procedures, donor site morbidity (e.g., pain, infection, and fracture), limited supply, and inconsistent osteogenic activity continue to be associated problems. The quality of an autograft is dependent upon the age and medical condition of the patient, as well as the number of viable mesenchymal and osteoprogenitor stem cells that are present in the specimen. This tissue is harvested during the surgical procedure; the process can prolong morbidity at the harvest site. The ideal bone graft would offer osteogenic cells, osteoinductive factors, and an osteoconductive matrix with a consistent supply of viable mesenchymal stem cells (MSCs) and osteoprogenitor cells (OPCs)-but without the morbidity of autograft.
Due to the limitations associated with autograft, researchers are pursuing the use of bone-graft substitutes to promote arthrodesis. Bone-graft substitutes now being used by surgeons include ceramic synthetics, bone morphogenic proteins (BMPs), demineralized bone matrices (DBMs) and other allografts; these may be used alone or in combination. Allografts available as substitutes for autograft offer some of the benefits of autograft without its limitations-but do not contain viable MSCs and OPCs.
Trinity Evolution is an allogeneic cancellous bone matrix containing demineralized cortical bone (DCB) as well as viable osteoprogenitor and mesenchymal stem cells. Adult mesenchymal stem cells and osteoprogenitor cells, such as those in Trinity Evolution, are the precursor cells that differentiate into osteoblasts-the cells responsible for bone growth and repair.
Trinity Evolution provides the required osteoconduction, osteogenesis, and osteoinductivity necessary for successful bone grafting. It offers viable osteoprogenitor and mesenchymal stem cells and demineralized cortical bone-all in a single product. Data from preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is a "minimally manipulated" tissue that is considered an allograft, and as such, is labeled for bone repair for all orthopedic and podiatric indications where autograft is used. In this study, Trinity Evolution will be used as a substitute for autograft and/or standard allograft in the following arthrodesis procedures: tibiotalar, subtalar, calcaneocuboid, talonavicular, double fusions (i.e. calcaneocuboid and talonavicular), and triple fusions (i.e. subtalar, calcaneocuboid, and talonavicular).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trinity Evolution | – | Biological: Trinity Evolution |
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 determined by orthopedic surgeon.
Key inclusion criteria (10 listed)
- Foot and/or ankle pathology requiring fusion using open surgical technique with supplemental bone graft/substitute requiring one of the following procedures:
- At least 18 years of age
- 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.
Key exclusion criteria (7 listed)
- Use of any other bone graft or bone graft substitute in addition to or in place of Trinity Evolution at the time of surgery
- Use of adjunctive post-operative stimulation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trinity EvolutionAlso: Allograft, Mesenchymal Stem CellsNovel Allogeneic, Cancellous, Bone Matrix Containing Viable Stem and Osteoprogenitor Cells | Biological | Trinity Evolution |
Primary outcome
Fusion Success
Time frame: 12 months
1 secondary outcome
Improvement in scores: Ankle-Hindfoot Scale (AHS), Visual Analog Scale (VAS), and Health Survey (SF-36v2).
Time frame: 12 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 28 Oct 2021.
Related trials for Tibiotalar Arthrodesis
Active, not recruitingObservational study
Orthofix PhysioStim PEMF Ankle Fusion Retrospective
Ankle Fusion, Hindfoot Arthrodesis
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 Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibiotalar Arthrodesis and Subtalar Arthrodesis, run by Orthofix Inc. at 10 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 10 inclusion and 7 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Success (time frame: 12 months). 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 28 Oct 2021.