Foot FusionNCT00583375
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
A study testing Augment® Bone Graft in people with Foot Fusion, run by BioMimetic Therapeutics at 37 sites in 2 countries.
Trial summary
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Fusion
- What is being tested?
- Augment® Bone Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 37 sitesin 2 countries
- Study dates
- Apr 2007to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 1) Bone defect in the hindfoot or ankle 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
- Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
- Double fusions (talonavicular and calcaneocuboid joints)
Who cannot join
- Previous fusion surgery of the proposed fusion site.
- The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day).
- Pregnant or a female intending to become pregnant during this study period.
- Morbidly obese (BMI > 45 kg/m2)
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States31 sites
The Orthopaedic Foot and Ankle Center
Arlington, Virginia, 22206
Union Memorial Hospital
Baltimore, Maryland, 21218
Orthopaedic & Neurosurgical Care & Research
Bend, Oregon, 97701
Ortho Carolina Research Institute
Charlotte, North Carolina, 28209
Cleveland Clinic
Cleveland, Ohio, 44195
Orthopedic Foot & Ankle Center
Columbus, Ohio, 43231
Duke Health Center
Durham, North Carolina, 27704
Mid Michigan Orthopaedic Institute
East Lansing, Michigan, 48823
Campbell Clinic
Germantown, Tennessee, 38138
Illinois Bone and Joint Institute, Ltd.
Glenview, Illinois, 60025
Orthopaedic Associates of Grand Rapids
Grand Rapids, Michigan, 49525
Hartford Hospital Orthopaedic Center
Hartford, Connecticut, 06106
Bone and Joint Clinic of Houston
Houston, Texas, 77030
Desert Orthopaedic Center
Las Vegas, Nevada, 89121
Marshfield Clinic
Marshfield, Wisconsin, 54449
Loyola University Medical Center
Maywood, Illinois, 60153
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Hospital for Special Surgery
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
UMDNJ
Newark, New Jersey, 07103
The Rothman Institute
Philadelphia, Pennsylvania, 19107
University Orthopaedics, Inc
Providence, Rhode Island, 02905
University of Rochester Medical Center
Rochester, New York, 14627
The Center for Bone & Joint Surgery
Royal Palm Beach, Florida, 33411
California Pacific Orthopaedics & Sports Medicine
San Francisco, California, 94118
Santa Cruz Orthopaedic Institute
Santa Cruz, California, 95065
Southern Orthopaedic Center
Savannah, Georgia, 31405
SIU School of Medicine
Springfield, Illinois, 62794
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Henry Ford Hospital - West Bloomfield
West Bloomfield, Michigan, 48322
Advanced Orthopaedic Associates
Wichita, Kansas, 67226
Canada6 sites
Peter Lougheed Centre
Calgary, Alberta, T1Y 6H6
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
The Ottawa Hospital, General Campus
Ottawa, Ontario, K1H 8L6
St. Michael's Hospital
Toronto, Ontario, M5C 1R6
University Health Network
Toronto, Ontario, M5T 2S8
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions)
STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis
Read more
STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft
REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA) Application as a bone regeneration system, pivotal phase
- Conditions
- Foot Fusion
- Being tested
- Augment® Bone Graft, Standard of Care
- Keywords
- 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 | Active comparator | Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft Receives: Procedure: Standard of Care |
| Group 2 | Experimental | 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.
Subjects Fused at 24 Weeks (as Determined by CT Assessment)
An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused.
Measured: 24 weeks
Secondary outcomes (5)
Pain on Weight Bearing
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).
- Clinically significant improvement: ≥20mm decrease from baseline
- Detectable improvement: 10-20mm decrease from baseline
- Maintained: <10mm decrease from baseline and <10mm increase from baseline
- Deteriorated: >10mm increase from baseline
Measured: 24 and 52 Weeks
Pain at Fusion Site
Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
- Clinically significant improvement: ≥20mm decrease from baseline
- Detectable improvement: 10-20mm decrease from baseline
- Maintained: <10mm decrease from baseline and <10mm increase from baseline
- Deteriorated: >10mm increase from baseline
Measured: 24 and 52 weeks
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. 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. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.
- Clinically significant improvement: ≥10 point decrease from baseline
- Improved: 5-10 point decrease from baseline
- Maintained: <5 point decrease from baseline and <5 point increase from baseline
- Deteriorated: >5 point increase from baseline
Measured: 24 and 52 weeks
AOFAS 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.
- Clinically significant improvement: ≥20 point increase from baseline
- Improved: 10-20 point increase from baseline
- Maintained: <10 point increase from baseline and <10 point decrease from baseline
- Deteriorated: >10 point decrease from baseline
Measured: 24 and 52 weeks
SF-12 Physical Component Score
The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life.
- Maintenance or improvement: ≥0 point increase from baseline
- Slight Decline: 0-10 point decrease from baseline
- Deteriorated: >10 point decrease from baseline
Measured: 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Foot FusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMimetic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher DiGiovanni, M.D., Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583375
- Sponsor's protocol ID
- BMTI-2006-01
- Status last verified
- Mar 2018
- First submitted
- 20 Dec 2007
- Last updated
- 2 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the 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
- NCT00583375
- Acronym / sponsor ID
- BMTI-2006-01
- Conditions
- Foot Fusion
- Keywords
- arthritis, ankle pain, foot pain, hindfoot fracture, ankle fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- BioMimetic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 23 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions)
STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis
STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft
REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA) Application as a bone regeneration system, pivotal phase
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Standard of CareStandard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft |
| Group 2 | Experimental | 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
Key inclusion criteria (7 listed)
- 1) Bone defect in the hindfoot or ankle 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
Key exclusion criteria (4 listed)
- Previous fusion surgery of the proposed fusion site.
- The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day).
- Pregnant or a female intending to become pregnant during this study period.
- Morbidly obese (BMI > 45 kg/m2)
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
Subjects Fused at 24 Weeks (as Determined by CT Assessment)
Time frame: 24 weeks
An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused.
5 secondary outcomes
Pain on Weight Bearing
Time frame: 24 and 52 Weeks
Pain at Fusion Site
Time frame: 24 and 52 weeks
Foot Function Index (FFI)
Time frame: 24 and 52 weeks
AOFAS Hindfoot and Ankle Score
Time frame: 24 and 52 weeks
SF-12 Physical Component Score
Time frame: 24 and 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christopher DiGiovanni, M.D. principal investigator
Rhode Island Hospital
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augment® Bone Graft in people with Foot Fusion, run by BioMimetic Therapeutics at 37 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 7 inclusion and 4 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 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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?
Yes. Results are posted in the registry (first posted 23 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subjects Fused at 24 Weeks (as Determined by CT Assessment) (time frame: 24 weeks). 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 2 Apr 2018.