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

BioMimetic Therapeutics

Status: Unknown

Conditions: Ankle and Hindfoot Arthrodesis

Treatments: Procedure: Standard of Care; Device: AUGMENT® Bone Graft

Study type: Observational

Funder types: Industry

Identifiers

NCT02879149

BMTI-2015-01

Details and patient eligibility

About

The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated 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-2006-01.

STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® 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: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects who meet the following criteria may be included in the study:

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 randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).

Exclusion criteria

1. Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 protocol.

Trial design

150 participants in 2 patient groups

Group 1

Description:

Standard Rigid Fixation plus autograft

Treatment:

Procedure: Standard of Care

Group 2

Description:

Standard rigid fixation plus AUGMENT® Bone Graft

Treatment:

Device: AUGMENT® Bone Graft