Arthritis Clinical Trial
Official title:
A Multi-Center, Randomized, Pilot Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery
The current research study evaluates an investigational medical device called Amplex B2A(TM)
Peptide Enhanced Ceramic Granules ("Amplex") for use in foot and ankle fusion. Amplex is a
synthetic bone graft material. The most frequently used graft material is bone collected
from the patient (autograft). Autograft involves a secondary incision with the risks of
infection and lasting pain.
The purpose of this study is to determine if Amplex is a safe and effective alternative to
autograft.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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