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Clinical Trials/NCT03998137
NCT03998137UnknownNot Applicable

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

BioMimetic Therapeutics0 sites94 target enrollmentStarted: August 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
94
Primary Endpoint
Pain on weight bearing via Visual Analog Scale (VAS)

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pain on weight bearing via Visual Analog Scale (VAS)

Time Frame: 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))
  • AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score(Visit 1 (Day 0))
  • Foot Function Index, FFI(Visit 1 (Day 0))

Investigators

Sponsor
BioMimetic Therapeutics
Sponsor Class
Industry
Responsible Party
Sponsor

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