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Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

NCT01305356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2018-12-26

Study results available
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Summary

STUDY OBJECTIVES:

To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)

STUDY HYPOTHESIS:

Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness

STUDY RATIONALE:

To evaluate a fully synthetic bone graft material to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft

Conditions

Interventions

DEVICE

Augment® Injectable Bone Graft

Implantation of up to 9cc of Augment® Injectable Bone Graft

PROCEDURE

Autologous bone graft

Implantation of up to 9cc of autologous bone graft

Sponsors & Collaborators

  • BioMimetic Therapeutics

    lead INDUSTRY

Principal Investigators

  • Stephen Roach · Stryker Trauma and Extremities

  • Christopher DiGiovanni, MD · University Orthopaedics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-04-30
Completion
2014-04-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305356 on ClinicalTrials.gov