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Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft

NCT03998137 — Unknown, 94 participants, BioMimetic Therapeutics
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A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

RegistryNCT03998137
StatusUnknown
Study typeObservational
Enrollment94 (Estimated)
SponsorBioMimetic Therapeutics (Industry)
ConditionsAnkle and Hindfoot Arthrodesis
InterventionsAUGMENT® Injectable Bone Graft, Standard of Care (Device, procedure)
Datesstart 2019-08-01 (estimated), primary completion 2021-06-01 (estimated), completion 2021-06-01 (estimated), first posted 2019-06-26, last updated 2019-07-09

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-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

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+Arms and interventions

ArmTypeInterventionsDescription
AutograftProcedure: Standard of CareStandard Rigid Fixation plus autograft
AUGMENT® InjectableDevice: AUGMENT® Injectable Bone GraftStandard rigid fixation plus AUGMENT® Injectable Bone Graft
  • AUGMENT® Injectable Bone Graft (Device): AUGMENT® Injectable Bone Graft
  • Standard of Care (Procedure): Autologous Bone Graft

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
2. Must have been included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED).

Exclusion Criteria:

1\) 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.

My Notes