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Augmentâ„¢ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

Study:

A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augmentâ„¢ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

Rationale:

n/a

Purpose:

STUDY OBJECTIVES: To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions) STUDY HYPOTHESIS: Augmentâ„¢ 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

Study Status: Active, not recruiting

Recruiting:
n/a

Condition Intervention Phase
Degenerative Joint Disease
Congenital Deformity
Arthritis
Osteoarthritis
Rheumatoid Arthritis
Device: Augment(tm) Injectable Bone Graft
Procedure: Autologous bone graft
Phase 3

Verified by BioMimetic Therapeutics October, 2012

Sponsored by: BioMimetic Therapeutics
Information provided by: BioMimetic Therapeutics
ClinicalTrials.gov identifier: NCT01305356

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic Orthopaedic
Cleveland, Ohio 44195
United States

Stephen Roach., Study Director
Christopher DiGiovanni, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
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