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

Ankle and Hindfoot Arthrodesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03998137
• Other study ID #: BMTI-2018-01
• Status: Not yet recruiting
• Start date: August 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2019
• Source: BioMimetic Therapeutics
• Contact: Justin Moss
• Phone: 615-236-4984
• Email: justin.moss[@]wright.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle and Hindfoot Arthrodesis

Intervention

Device:
• AUGMENT® Injectable Bone Graft
AUGMENT® Injectable Bone Graft

Procedure:
• Standard of Care
Autologous Bone Graft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioMimetic Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on weight bearing via Visual Analog Scale (VAS)	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).	Visit 1 (Day 0)
Secondary	Confirmation of bridging bone via computerized tomography (CT)	Overall Assessment of Osseous Bridging (% Bone Bridging; CT Scans); Absent (0-24%); Minimal (25-49%); Moderate (50-74%); Complete (75-100%)	Visit 1 (Day 0)
Secondary	AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score	Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes.	Visit 1 (Day 0)
Secondary	Foot Function Index, FFI	The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.	Visit 1 (Day 0)