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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
299
Implantation of up to 9cc of Augment® Injectable Bone Graft
Implantation of up to 9cc of autologous bone graft
Tucson Orthopaedic Research Center
Tucson, Arizona, United States
University of Arizona
Tucson, Arizona, United States
California Pacific Medical Center
San Francisco, California, United States
Illinois Bone & Joint Institute, Ltd.
Glenview, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Mid Michigan Orthopaedic Institute
East Lansing, Michigan, United States
Orthopaedic Associates of Michigan, PC
Grand Rapids, Michigan, United States
Desert Orthopaedic Center
Las Vegas, Nevada, United States
University of Medicine & Dentistry of New Jersey
Newark, New Jersey, United States
...and 15 more locations
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).
Time frame: Baseline, 9, 12, 16, 24, 36, 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 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks
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