Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
- Conditions
- Ankle and Hindfoot Arthrodesis
- Interventions
- Procedure: Standard of CareDevice: AUGMENT® Injectable Bone Graft
- Registration Number
- NCT03998137
- Lead Sponsor
- BioMimetic Therapeutics
- Brief Summary
The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft under protocol BMTI-2006-01.
Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2009-01 or BMTI-2010-01.
STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Injectable Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.
REGULATORY PHASE: Post-approval study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 94
- Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
- Must have been included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED).
- Subjects that were excluded from the safety analysis in the BMTI-2009-01 or BMTI-2010-01 study. These subjects were consented, but never treated as part of the BMTI-2009-01 or BMTI-2010-01 protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Autograft Standard of Care Standard Rigid Fixation plus autograft AUGMENT® Injectable AUGMENT® Injectable Bone Graft Standard rigid fixation plus AUGMENT® Injectable Bone Graft
- Primary Outcome Measures
Name Time Method Pain on weight bearing via Visual Analog Scale (VAS) Visit 1 (Day 0) 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).
- Secondary Outcome Measures
Name Time Method Confirmation of bridging bone via computerized tomography (CT) Visit 1 (Day 0) Overall Assessment of Osseous Bridging (% Bone Bridging; CT Scans)
* Absent (0-24%)
* Minimal (25-49%)
* Moderate (50-74%)
* Complete (75-100%)AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score Visit 1 (Day 0) 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.
Foot Function Index, FFI Visit 1 (Day 0) 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.