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

BioMimetic Therapeutics

Status

Unknown

Conditions

Ankle and Hindfoot Arthrodesis

Treatments

Procedure: Standard of Care

Device: AUGMENT® Injectable Bone Graft

Study type

Observational

Funder types

Industry

Identifiers

NCT03998137

BMTI-2018-01

Details and patient eligibility

About

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

Enrollment

94 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.