Degenerative Joint DiseaseNCT01305356
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
A study testing Augment® Injectable Bone Graft and Autologous bone graft in people with Degenerative Joint Disease and Congenital Deformity, run by BioMimetic Therapeutics at 25 sites in 2 countries.
Trial summary
STUDY OBJECTIVES: To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions) STUDY HYPOTHESIS: Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Joint Disease, Congenital Deformity, Arthritis
- What is being tested?
- Augment® Injectable Bone Graft and Autologous bone graft
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Mar 2011to Apr 2014
- 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
- at least 18 years old and considered skeletally mature
- diagnosed with degenerative joint disease (DJD) affecting the hindfoot due to a congenital or acquired deformity, osteoarthritis, rheumatoid arthritis, post- traumatic arthritis or ankylosing spondylitis of the ankle, subtalar, calcaneocuboid, and/or talonavicular joints
- requires one of the following hindfoot fusion proceduress with supplemental bone graft/substitute: ankle fusion (tibiotalar), subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints) OR double fusions (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints)
- fusion site able to be rigidly stabilized with no more than 3 screws across the fusion site
- supplemental pins or staples allowed
- supplemental screws external to the fusion site(s) allowed
- signed informed consent document, independent, ambulatory, and can comply with all post-operative evaluations and visits
Who cannot join
- undergone previous fusion surgery at the proposed location, i.e., revision of a failed fusion
- more than one previous procedure at the involved joints
- retained hardware spanning the joint(s) intended for fusion
- procedure anticipated to require plate fixation (including claw plates), IM nails or more than 3 screws to achieve rigid fixation based on pre-op planning
- procedure expected to require more than 9cc of graft material based on pre-op planning
- procedure expected to require structural bone graft, allograft, bone graft substitute, platelet rich plasma (PRP) or bone marrow aspirate
Show all 21Show fewer
- procedure expected to require a pantalar fusion, i.e., fusion of ankle plus all hindfoot joints (talonavicular, subtalar, and calcaneocuboid) or an ankle fusion in combination with any hindfoot fusion
- radiographic evidence of bone cysts, segmental defects or growth plate fracture near the fusion site that could negatively impact the proposed fusion procedure
- tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed surgical site
- pre-existing sensory impairment, e.g., diabetics with baseline sensory impairment, which limits ability to perform objective functional measurements and may be at risk for complications
- diabetics not sensitive to the 5.07 monofilament (Semmes-Weinstein) are to be excluded
- metabolic disorder known to adversely affect the skeleton other than primary osteoporosis or diabetes, e.g., renal osteodystrophy or hypercalcemia
- use of chronic medications known to affect the skeleton, e.g., glucocorticoid usage > 10mg/day
- pre-fracture neuromuscular or musculoskeletal deficiency which limits the ability to perform objective functional measurements
- physically or mentally compromised, e.g., current treatment for a psychiatric disorder, senile dementia, Alzheimer's disease, etc., to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant
- allergic to yeast-derived products or bovine collagen or other bovine-sourced products
- received an investigational therapy within 30 days of proposed surgery or during the follow-up phase of the study
- is a prisoner, known or suspected transient or a history of drug/alcohol abuse within the 12 months prior to screening
- pregnant or intending to become pregnant within 12 months of the study procedure
- morbidly obese defined as BMI > 45 kg/m2
- currently has an acute infection at the surgical site
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States20 sites
Union Memorial Hospital
Baltimore, Maryland, 21218
OrthoCarolina, PA
Charlotte, North Carolina, 28207
Cleveland Clinic Orthopaedic
Cleveland, Ohio, 44195
Orthopedic Foot & Ankle Center
Columbus, Ohio, 43231
Texas Health Research & Education Institute
Dallas, Texas, 75231
Mid Michigan Orthopaedic Institute
East Lansing, Michigan, 48823
Illinois Bone & Joint Institute, Ltd.
Glenview, Illinois, 60025
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525
St. Luke's Episcopal Hospital
Houston, Texas, 77030
Desert Orthopaedic Center
Las Vegas, Nevada, 89121
Loyola University Medical Center
Maywood, Illinois, 60153
Campbell Clinic / InMotion Orthopaedic Research Center
Memphis, Tennessee, 38138
Hospital for Special Surgery
New York, New York, 10021
University of Medicine & Dentistry of New Jersey
Newark, New Jersey, 07101
Health Research Institute, Inc.
Oklahoma City, Oklahoma, 73109
The Rothman Institute
Philadelphia, Pennsylvania, 19107
University of Rochester Medical Center
Rochester, New York, 14642
California Pacific Medical Center
San Francisco, California, 94118
Tucson Orthopaedic Research Center
Tucson, Arizona, 85712
University of Arizona
Tucson, Arizona, 85724
Canada5 sites
Life Mark Health Centre
Calgary, Alberta
Queen Elizabeth II Health Services
Halifax, Nova Scotia, B3H3A7
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
St. Michael's Hospital
Toronto, Ontario, M5C1R6
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6
About this study
Official title: A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
STUDY OBJECTIVES:
To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)
Read more
STUDY HYPOTHESIS:
Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness
STUDY RATIONALE:
To evaluate a fully synthetic bone graft material 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 Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft
Read the detailed description
STUDY DESIGN:
Prospective, randomized, controlled, non-inferiority, multi-center trial
NUMBER OF STUDY CENTERS:
25
NUMBER OF SUBJECTS:
299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3 separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01)
STUDY POPULATION:
Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure.
TREATMENT GROUPS:
Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment® Injectable Bone Graft
Subjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft).
ROUTE OF ADMINISTRATION:
Investigational device is manually implanted inside and around the fusion space to ensure Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space
STUDY DURATION:
Twenty-four month follow-up post-surgery
- Conditions
- Degenerative Joint Disease, Congenital Deformity, Arthritis, Osteoarthritis, Rheumatoid Arthritis
- Being tested
- Augment® Injectable Bone Graft, Autologous bone graft
- Keywords
- degenerative joint disease, DJD, joint fusion, hindfoot, congenital deformity, osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ankylosing spondylitis, Augment(tm) Injectable Bone Graft, autologous bone graft, autogenous bone graft, beta-TCP, bovine collagen, rhPDGF(bb)
- Medical subject headings
- Joint Diseases, Congenital Abnormalities, Arthritis, Osteoarthritis, Arthritis, Rheumatoid, Ankylosis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augment® Injectable Bone GraftDevice
Implantation of up to 9cc of Augment® Injectable Bone Graft
Autologous bone graftProcedure or surgery
Implantation of up to 9cc of autologous bone graft
| Study group | Role | What they receive |
|---|---|---|
| Augment® Injectable Bone Graft | Experimental | Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) Receives: Device: Augment® Injectable Bone Graft |
| Autologous bone graft | Active comparator | Standard Rigid Fixation + Autologous bone graft Receives: Procedure: Autologous bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 9, 12, 16, 24, 36, and 52 weeks
Secondary outcomes (4)
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: Baseline, 9, 12, 16, 24, 36, 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.
Measured: Baseline, 9, 12, 16, 24, 36, and 52 weeks
Fusion Site Pain
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).
Measured: Baseline, 9, 12, 16, 24, 36, 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.
Measured: Baseline, 9, 12, 16, 24, 36, 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 posted28 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2014
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Degenerative Joint 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMimetic Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Roach, Study director, Stryker Trauma and ExtremitiesChristopher DiGiovanni, MD, Principal investigator, University Orthopaedics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305356
- Sponsor's protocol ID
- BMTI-2010-01
- Status last verified
- Dec 2018
- First submitted
- 25 Feb 2011
- Last updated
- 26 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Daniels TR, Younger AS, Penner MJ, Wing KJ, Le IL, Russell IS, Lalonde KA, Evangelista PT, Quiton JD, Glazebrook M, DiGiovanni CW. Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a beta-TCP-Collagen Matrix. Foot Ankle Int. 2015 Jul;36(7):739-48. doi: 10.1177/1071100715576370. Epub 2015 Apr 6.
PubMed 25848134DiGiovanni CW, Lin SS, Baumhauer JF, Daniels T, Younger A, Glazebrook M, Anderson J, Anderson R, Evangelista P, Lynch SE; North American Orthopedic Foot and Ankle Study Group. Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/beta-TCP): an alternative to autogenous bone graft. J Bone Joint Surg Am. 2013 Jul 3;95(13):1184-92. doi: 10.2106/JBJS.K.01422.
PubMed 23824386
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 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® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
- ClinicalTrials.gov ID
- NCT01305356
- Acronym / sponsor ID
- BMTI-2010-01
- Conditions
- Degenerative Joint Disease, Congenital Deformity, Arthritis, Osteoarthritis, Rheumatoid Arthritis
- Keywords
- degenerative joint disease, DJD, joint fusion, hindfoot, congenital deformity, osteoarthritis, rheumatoid arthritis, post-traumatic arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- BioMimetic TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Posted 5 Dec 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:
To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)
STUDY HYPOTHESIS:
Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness
STUDY RATIONALE:
To evaluate a fully synthetic bone graft material 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 Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft
Detailed description
STUDY DESIGN:
Prospective, randomized, controlled, non-inferiority, multi-center trial
NUMBER OF STUDY CENTERS:
25
NUMBER OF SUBJECTS:
299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3 separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01)
STUDY POPULATION:
Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure.
TREATMENT GROUPS:
Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment® Injectable Bone Graft
Subjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft).
ROUTE OF ADMINISTRATION:
Investigational device is manually implanted inside and around the fusion space to ensure Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space
STUDY DURATION:
Twenty-four month follow-up post-surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augment® Injectable Bone Graft | Experimental | Device: Augment® Injectable Bone GraftStandard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB) |
| Autologous bone graft | Active comparator | Procedure: Autologous bone graftStandard Rigid Fixation + Autologous 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)
- at least 18 years old and considered skeletally mature
- diagnosed with degenerative joint disease (DJD) affecting the hindfoot due to a congenital or acquired deformity, osteoarthritis, rheumatoid arthritis, post- traumatic arthritis or ankylosing spondylitis of the ankle, subtalar, calcaneocuboid, and/or talonavicular joints
- requires one of the following hindfoot fusion proceduress with supplemental bone graft/substitute: ankle fusion (tibiotalar), subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints) OR double fusions (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints)
- fusion site able to be rigidly stabilized with no more than 3 screws across the fusion site
- signed informed consent document, independent, ambulatory, and can comply with all post-operative evaluations and visits
Key exclusion criteria (21 listed)
- undergone previous fusion surgery at the proposed location, i.e., revision of a failed fusion
- more than one previous procedure at the involved joints
- retained hardware spanning the joint(s) intended for fusion
- procedure anticipated to require plate fixation (including claw plates), IM nails or more than 3 screws to achieve rigid fixation based on pre-op planning
- procedure expected to require more than 9cc of graft material based on pre-op planning
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 GraftImplantation of up to 9cc of Augment® Injectable Bone Graft | Device | Augment® Injectable Bone Graft |
| Autologous bone graftImplantation of up to 9cc of autologous bone graft | Procedure or surgery | Autologous bone graft |
Primary outcome
Pain on Weight Bearing
Time frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks
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).
4 secondary outcomes
Foot Function Index (FFI)
Time frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks
AOFAS Hindfoot and Ankle Score
Time frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks
Fusion Site Pain
Time frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks
SF-12 Physical Component Score
Time frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25848134Daniels TR, Younger AS, Penner MJ, Wing KJ, Le IL, Russell IS, Lalonde KA, Evangelista PT, Quiton JD, Glazebrook M, DiGiovanni CW. Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a beta-TCP-Collagen Matrix. Foot Ankle Int. 2015 Jul;36(7):739-48. doi: 10.1177/1071100715576370. Epub 2015 Apr 6.
- Results publication: PubMed 23824386DiGiovanni CW, Lin SS, Baumhauer JF, Daniels T, Younger A, Glazebrook M, Anderson J, Anderson R, Evangelista P, Lynch SE; North American Orthopedic Foot and Ankle Study Group. Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/beta-TCP): an alternative to autogenous bone graft. J Bone Joint Surg Am. 2013 Jul 3;95(13):1184-92. doi: 10.2106/JBJS.K.01422.
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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.
Stephen Roach study director
Stryker Trauma and Extremities
Christopher DiGiovanni, MD principal investigator
University Orthopaedics, Inc.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augment® Injectable Bone Graft and Autologous bone graft in people with Degenerative Joint Disease and Congenital Deformity, run by BioMimetic Therapeutics at 25 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 21 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 5 Dec 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?
Pain on Weight Bearing (time frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01305356, which also lists 2 linked publications.
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 26 Dec 2018.