Ankle and Hindfoot ArthrodesisNCT02879149
Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
An observational study of Ankle and Hindfoot Arthrodesis, run by BioMimetic Therapeutics at 26 sites in 2 countries.
Trial summary
The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated 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® Bone Graft
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 150 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Aug 2016to Dec 2018
- 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-2006-01 protocol.
Who may be able to join
- Subjects who meet the following criteria may be included in the study:
- 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 randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).
Who cannot join
- 1) Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 protocol.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States21 sites, 21 recruiting
- Recruiting
MedStar Health Research Institute/ Union Memorial Hospital
Baltimore, Maryland, 21218
Flossine Brown, BS, CRC, 410-554-4451, flossine.brown@medstar.net
Lew Schon, M.D.
- Recruiting
The Center
Bend, Oregon, 97701
Meredith Dawson, 541-382-2653, mdawson@thecenteroregon.com
Tony Hinz, MD
- Recruiting
OrthoNorcal
Capitola, California, 95010
Clay Christensen, 831-475-4024 ext. 149, cchristensen@orthonorcal.com
Nicholas Abidi, MD
- Recruiting
OrthoCarolina
Charlotte, North Carolina, 28207
Katherine Prassas, 704-323-2266, Katherine.prassas@orthocarolina.com
Robert Anderson, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Maxine Cox, 216-444-5436, coxm@ccf.org
Mark Berkowitz, M.D.
- Recruiting
Duke University Medical
Durham, North Carolina
Christina Van Sant, 919-668-9175, christina.van.sant@duke.edu
Mark Easley, M.D.
- Recruiting
The Orthopaedic Foot & Ankle Center
Falls Church, Virginia, 22042
Nicole Patterson, 703-584-2040, npatterson@footankledc.com
Steven Neufeld, MD
- Recruiting
Campbell Clinic
Germantown, Tennessee, 38138
Marian Shaw, 901-435-5705, mshaw@campbell-foundation.org
Andrew Murphy, MD
- Recruiting
Illinois Bone and Joint Institute, LLC
Glenview, Illinois, 60025
Steven Haddad, MD, 847-998-5680, slhaddadmd@gmail.com
Steven Haddad, MD
- Recruiting
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525
Michelle Padley, 616-459-7101 ext. 1797, Michelle.Padley@oamichigan.com
John Anderson, MD
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Jamie Fish-Fuhrmann, 860-972-5311, Jamie.fish-fuhrmann@hhchealth.org
Raymond Sullivan, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Melyssa Fink, 832-355-3710, Melyssa.Fink@bcm.edu
William Granberry, MD
- Recruiting
Michigan Orthopedic Center
Lansing, Michigan, 48910
Wendy Downey, 517-267-0200, Wdowney07@hotmail.com
Michael Swords, MD
- Recruiting
Desert Orthopaedics
Las Vegas, Nevada, 89121
Madison Hurley, 702-731-1616, hurlem1@unlv.nevada.edu
Troy Watson, MD
- Recruiting
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Melody Aldred, PhD, 973-972-5435, Melody26@njms.rutgers.edu
Sheldon Lin, M.D.
- Recruiting
Rothman Institute
Philadelphia, Pennsylvania, 19107
Ioanna Kosmaoglou, 267-339-3613, Ioanna.Kosmaoglou@rothmaninstitute.com
Steven Raikin, MD
- Recruiting
University of Rochester
Rochester, New York, 14642
Hayley McDermott, 585-341-0556, Hayley_Mcdermott@URMC.Rochester.edu
Judith Baumhauer, MD
- Recruiting
Center for Bone and Joint Surgery
Royal Palm Beach, Florida, 33411
Samantha Levy, 561-633-4241, samantha.levy@boneandjoint.org
Robert Rochman, MD
- Recruiting
California Pacific Medical Center
San Francisco, California, 94118
Wilson Ling, 415-600-3148, LingW@cpmcri.org
Keith Donatto, M.D.
- Recruiting
Tucson Orthopedic Institute
Tucson, Arizona, 85712
Jelena Candito, 520-784-6446, jcandito@tucsonortho.com
Nebojsa Skrepnik, MD
- Recruiting
Orthopedic Foot and Ankle Center / OhioHealth Research Institute
Westerville, Ohio, 43082
Emily Stansbury, 614-895-2424, stansburyet@orthofootankle.com
Gregory Berlet, M.D.
Canada5 sites, 5 recruiting
- Recruiting
Office of Orthopaedic Surgeons, Talisman Centre North Building
Calgary, Alberta, T2G 5B6
Tara Heric, 403-671-8645, jditara@yahoo.ca
Ian Le, MD
- Recruiting
QEll Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Trish Francis, RN, 902 473 5993, francisp@nsheath.ca
Mark Glazebrook, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5C 1R6
Ryan Khan, 416-864-6060 ext. 3890, khanry@smh.ca
Timothy Daniels, M.D.
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Antonietta Fazio, 416-603-5800 ext. 7347, afazio@uhnresearch.ca
Johnny Lau, M.D.
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z-2A5
Biraj Bora, 604-806-8743, bbora@providencehealth.bc.ca
Alastair Younger
About this study
Official title: A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® 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® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated 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-2006-01.
STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® 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® Bone Graft, Standard of Care
- Keywords
- Ankle Fusions, AUGMENT® 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® Bone GraftDevice
AUGMENT® Bone Graft
Standard of CareProcedure or surgery
Autologous Bone Graft
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Standard Rigid Fixation plus autograft Receives: Procedure: Standard of Care | |
| Group 2 | Standard rigid fixation plus AUGMENT® Bone Graft Receives: Device: AUGMENT® Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of bridging bone via CT
Measured: Months 60 or greater
Subject function as determined by pain on weight bearing
Measured: Months 60 or greater
Subject function as determined by AOFAS - AHS score
Measured: Months 60 or greater
Subject function as determined by Foot Function Index
Measured: Months 60 or greater
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (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
- 150 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
- NCT02879149
- Sponsor's protocol ID
- BMTI-2015-01
- Status last verified
- Mar 2018
- First submitted
- 17 Aug 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. 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® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
- ClinicalTrials.gov ID
- NCT02879149
- Acronym / sponsor ID
- BMTI-2015-01
- Conditions
- Ankle and Hindfoot Arthrodesis
- Keywords
- Ankle Fusions, AUGMENT® Bone Graft, Autologous Bone Graft, arthritis, ankle pain, foot pain, hindfoot fracture, ankle fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- BioMimetic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Aug 2016 (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 objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated 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-2006-01.
STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® 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 |
|---|---|---|
| Group 1 | – | Procedure: Standard of CareStandard Rigid Fixation plus autograft |
| Group 2 | – | Device: AUGMENT® Bone GraftStandard rigid fixation plus AUGMENT® 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-2006-01 protocol.
Key inclusion criteria (3 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 randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).
Key exclusion criteria (1 listed)
- 1) Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 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® Bone GraftAUGMENT® Bone Graft | Device | Group 2 |
| Standard of CareAutologous Bone Graft | Procedure or surgery | Group 1 |
Primary outcome
Demonstration of bridging bone via CT
Time frame: Months 60 or greater
Subject function as determined by pain on weight bearing
Time frame: Months 60 or greater
Subject function as determined by AOFAS - AHS score
Time frame: Months 60 or greater
Subject function as determined by Foot Function Index
Time frame: Months 60 or greater
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle and Hindfoot Arthrodesis, run by BioMimetic Therapeutics at 26 sites in 2 countries.
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 3 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 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Roach (615-656-7466, Stephen.Roach@wright.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of bridging bone via CT (time frame: Months 60 or greater). The study lists 4 primary outcomes in all. 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 27 Mar 2018.