Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
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|ClinicalTrials.gov Identifier: NCT01305356|
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : December 5, 2018
Last Update Posted : December 26, 2018
To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)
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
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
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Joint Disease Congenital Deformity Arthritis Osteoarthritis Rheumatoid Arthritis||Device: Augment® Injectable Bone Graft Procedure: Autologous bone graft||Not Applicable|
Prospective, randomized, controlled, non-inferiority, multi-center trial
NUMBER OF STUDY CENTERS:
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)
Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure.
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
Twenty-four month follow-up post-surgery
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||March 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2014|
Experimental: Augment® Injectable Bone Graft
Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
Device: Augment® Injectable Bone Graft
Implantation of up to 9cc of Augment® Injectable Bone Graft
Active Comparator: Autologous bone graft
Standard Rigid Fixation + Autologous bone graft
Procedure: Autologous bone graft
Implantation of up to 9cc of autologous bone graft
- 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).
- Foot Function Index (FFI) [ Time Frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks ]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.
- AOFAS Hindfoot and Ankle Score [ Time Frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks ]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.
- Fusion Site Pain [ Time Frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks ]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).
- SF-12 Physical Component Score [ Time Frame: Baseline, 9, 12, 16, 24, 36, and 52 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305356
|Study Director:||Stephen Roach||Wright Medical Technology|
|Principal Investigator:||Christopher DiGiovanni, MD||University Orthopaedics, Inc.|