Ankle and Hindfoot ArthrodesisNCT03998137
Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
An observational study of Ankle and Hindfoot Arthrodesis, run by BioMimetic Therapeutics.
Trial summary
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft under protocol BMTI-2006-01. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle and Hindfoot Arthrodesis
- What is being tested?
- AUGMENT® Injectable Bone Graft
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Jun 2021
- 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: Male and female subjects over the age of 18 years of age, who were randomized and treated as part of the population of the BMTI-2009-01 or BMTI-2010-01 protocol.
Who may be able to join
- Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
- Must have been included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED).
Who cannot join
- 1) Subjects that were excluded from the safety analysis in the BMTI-2009-01 or BMTI-2010-01 study. These subjects were consented, but never treated as part of the BMTI-2009-01 or BMTI-2010-01 protocol.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft under protocol BMTI-2006-01.
Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2009-01 or BMTI-2010-01.
Read more
STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Injectable Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.
REGULATORY PHASE: Post-approval study
- Conditions
- Ankle and Hindfoot Arthrodesis
- Being tested
- AUGMENT® Injectable Bone Graft, Standard of Care
- Keywords
- Ankle Fusions, AUGMENT® Injectable Bone Graft, Autologous Bone Graft, arthritis, ankle pain, foot pain, hindfoot fracture, ankle fracture
- Medical subject headings
- Arthritis, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUGMENT® Injectable Bone GraftDevice
AUGMENT® Injectable Bone Graft
Standard of CareProcedure or surgery
Autologous Bone Graft
| Study group | Role | What they receive |
|---|---|---|
| Autograft | Standard Rigid Fixation plus autograft Receives: Procedure: Standard of Care | |
| AUGMENT® Injectable | Standard rigid fixation plus AUGMENT® Injectable Bone Graft Receives: Device: AUGMENT® Injectable Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on weight bearing via Visual Analog Scale (VAS)
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Measured: Visit 1 (Day 0)
Secondary outcomes (3)
Confirmation of bridging bone via computerized tomography (CT)
Overall Assessment of Osseous Bridging (% Bone Bridging; CT Scans)
- Absent (0-24%)
- Minimal (25-49%)
- Moderate (50-74%)
- Complete (75-100%)
Measured: Visit 1 (Day 0)
AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score
Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.
Measured: Visit 1 (Day 0)
Foot Function Index, FFI
The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.
Measured: Visit 1 (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study startAug 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle and Hindfoot 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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioMimetic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998137
- Sponsor's protocol ID
- BMTI-2018-01
- Status last verified
- Jul 2019
- First submitted
- 19 Jun 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
- ClinicalTrials.gov ID
- NCT03998137
- Acronym / sponsor ID
- BMTI-2018-01
- Conditions
- Ankle and Hindfoot Arthrodesis
- Keywords
- Ankle Fusions, AUGMENT® Injectable Bone Graft, Autologous Bone Graft, arthritis, ankle pain, foot pain, hindfoot fracture, ankle fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- BioMimetic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 26 Jun 2019 (actual)
- 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 objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft under protocol BMTI-2006-01.
Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2009-01 or BMTI-2010-01.
STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Injectable Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.
REGULATORY PHASE: Post-approval study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autograft | – | Procedure: Standard of CareStandard Rigid Fixation plus autograft |
| AUGMENT® Injectable | – | Device: AUGMENT® Injectable Bone GraftStandard rigid fixation plus AUGMENT® Injectable Bone Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects over the age of 18 years of age, who were randomized and treated as part of the population of the BMTI-2009-01 or BMTI-2010-01 protocol.
Key inclusion criteria (2 listed)
- Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
- Must have been included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED).
Key exclusion criteria (1 listed)
- 1) Subjects that were excluded from the safety analysis in the BMTI-2009-01 or BMTI-2010-01 study. These subjects were consented, but never treated as part of the BMTI-2009-01 or BMTI-2010-01 protocol.
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 |
|---|---|---|
| AUGMENT® Injectable Bone GraftAUGMENT® Injectable Bone Graft | Device | AUGMENT® Injectable |
| Standard of CareAutologous Bone Graft | Procedure or surgery | Autograft |
Primary outcome
Pain on weight bearing via Visual Analog Scale (VAS)
Time frame: Visit 1 (Day 0)
Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
3 secondary outcomes
Confirmation of bridging bone via computerized tomography (CT)
Time frame: Visit 1 (Day 0)
AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score
Time frame: Visit 1 (Day 0)
Foot Function Index, FFI
Time frame: Visit 1 (Day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle and Hindfoot Arthrodesis, run by BioMimetic Therapeutics.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Moss (615-236-4984, justin.moss@wright.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on weight bearing via Visual Analog Scale (VAS) (time frame: Visit 1 (Day 0)). 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 9 Jul 2019.