Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01305356
Brief 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
Detailed Description:
STUDY DESIGN:
Prospective, randomized, controlled, non-inferiority, multi-center trial
NUMBER OF STUDY CENTERS:
25
NUMBER OF SUBJECTS:
299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3 separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01)
STUDY POPULATION:
Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure.
TREATMENT GROUPS:
Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment® Injectable Bone Graft
Subjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft).
ROUTE OF ADMINISTRATION:
Investigational device is manually implanted inside and around the fusion space to ensure Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space
STUDY DURATION:
Twenty-four month follow-up post-surgery
Study:
NCT01305356
Study Brief:
Protocol Section:
NCT01305356