Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
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
1 other identifier
interventional
299
2 countries
25
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
Typical duration for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2011
CompletedFirst Posted
Study publicly available on registry
February 28, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
December 5, 2018
CompletedDecember 26, 2018
December 1, 2018
2.1 years
February 25, 2011
October 30, 2018
December 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline, 9, 12, 16, 24, 36, and 52 weeks
Secondary Outcomes (4)
Foot Function Index (FFI)
Baseline, 9, 12, 16, 24, 36, and 52 weeks
AOFAS Hindfoot and Ankle Score
Baseline, 9, 12, 16, 24, 36, and 52 weeks
Fusion Site Pain
Baseline, 9, 12, 16, 24, 36, and 52 weeks
SF-12 Physical Component Score
Baseline, 9, 12, 16, 24, 36, and 52 weeks
Study Arms (2)
Augment® Injectable Bone Graft
EXPERIMENTALStandard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
Autologous bone graft
ACTIVE COMPARATORStandard Rigid Fixation + Autologous bone graft
Interventions
Implantation of up to 9cc of Augment® Injectable Bone Graft
Implantation of up to 9cc of autologous bone graft
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Tucson Orthopaedic Research Center
Tucson, Arizona, 85712, United States
University of Arizona
Tucson, Arizona, 85724, United States
California Pacific Medical Center
San Francisco, California, 94118, United States
Illinois Bone & Joint Institute, Ltd.
Glenview, Illinois, 60025, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Union Memorial Hospital
Baltimore, Maryland, 21218, United States
Mid Michigan Orthopaedic Institute
East Lansing, Michigan, 48823, United States
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, 49525, United States
Desert Orthopaedic Center
Las Vegas, Nevada, 89121, United States
University of Medicine & Dentistry of New Jersey
Newark, New Jersey, 07101, United States
Hospital for Special Surgery
New York, New York, 10021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
OrthoCarolina, PA
Charlotte, North Carolina, 28207, United States
Cleveland Clinic Orthopaedic
Cleveland, Ohio, 44195, United States
Orthopedic Foot & Ankle Center
Columbus, Ohio, 43231, United States
Health Research Institute, Inc.
Oklahoma City, Oklahoma, 73109, United States
The Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Campbell Clinic / InMotion Orthopaedic Research Center
Memphis, Tennessee, 38138, United States
Texas Health Research & Education Institute
Dallas, Texas, 75231, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Life Mark Health Centre
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
Queen Elizabeth II Health Services
Halifax, Nova Scotia, B3H3A7, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H8L6, Canada
St. Michael's Hospital
Toronto, Ontario, M5C1R6, Canada
Related Publications (2)
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.
PMID: 25848134RESULTDiGiovanni 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.
PMID: 23824386RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Justin Moss
- Organization
- Wright Medical
Study Officials
- STUDY DIRECTOR
Stephen Roach
Stryker Trauma and Extremities
- PRINCIPAL INVESTIGATOR
Christopher DiGiovanni, MD
University Orthopaedics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2011
First Posted
February 28, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2014
Last Updated
December 26, 2018
Results First Posted
December 5, 2018
Record last verified: 2018-12