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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-31

Study Completion Date

2021-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Ankle and Hindfoot Arthrodesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Autograft

Standard Rigid Fixation plus autograft

Standard of Care

Intervention Type PROCEDURE

Autologous Bone Graft

AUGMENT® Injectable

Standard rigid fixation plus AUGMENT® Injectable Bone Graft

AUGMENT® Injectable Bone Graft

Intervention Type DEVICE

AUGMENT® Injectable Bone Graft

Interventions

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AUGMENT® Injectable Bone Graft

Intervention Type DEVICE

Standard of Care

Autologous Bone Graft

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No