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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02879149

Enrollment

150

Registered

2016-08-25

Start date

2016-08-31

Completion date

2018-12-31

Last updated

2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle and Hindfoot Arthrodesis

Keywords

Ankle Fusions, AUGMENT® Bone Graft, Autologous Bone Graft, arthritis, ankle pain, foot pain, hindfoot fracture, ankle fracture

Brief summary

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

Interventions

DEVICEAUGMENT® Bone Graft

AUGMENT® Bone Graft

PROCEDUREStandard of Care

Autologous Bone Graft

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Demonstration of bridging bone via CT	Months 60 or greater
Subject function as determined by pain on weight bearing	Months 60 or greater
Subject function as determined by AOFAS - AHS score	Months 60 or greater
Subject function as determined by Foot Function Index	Months 60 or greater

Countries

Canada, United States

Contacts

Primary ContactStephen Roach

Stephen.Roach@wright.com615-656-7466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026