STAR ANKLE JOINT REPLACEMENTS LAST LONG TERM AND PROVIDE RELIEF FOR PATIENTS
NEW YORK, NY: May 2, 2011 – A report on the STAR™ Ankle prosthesis published in the journal, Foot & Ankle International (May 2011 edition, Volume 32 #5 © American Orthopaedic Foot & Ankle Society) is the first long term U.S. prospective study of the three-part STAR total ankle joint replacement following the Pre Market Approval (PMA) by the FDA (U.S. Food and Drug Administration) in May 2009. Foot and ankle surgeons, Jeffrey A. Mann MD, Roger A. Mann MD and Eric Horton MD of Oakland, CA reported that 91 percent of prostheses remain implanted at an average follow-up of 9.1 years. Further, 92 percent of the patients were satisfied with their outcome.
The long term study was conducted on 84 STAR total ankle replacements, performed in 80 patients. Postoperatively, patients were evaluated with the AOFAS® (American Orthopaedic Foot & Ankle Society) score for pain and function, and serial radiographs were evaluated for stability and alignment of the prosthesis. Implant failure, secondary procedures, and complications were recorded. The report notes a statistically significant decrease in pain and improvement of functional outcomes.
The report concluded that "the first U.S. prospective long-term survivorship data with the STAR Ankle prosthesis found it to be an excellent long-term option for the treatment of ankle arthritis."
David B. Thordarson MD, Editor-in-Chief of Foot & Ankle International, commented: "These results help confirm longer term observations of total ankle replacement patients in Europe and will lead to greater acceptance and progress of the procedure in the U.S."
A copy of the article is available to non-subscribers of Foot & Ankle International at:
¹The authors are paid consultants to SBi.
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC (VB), the New York-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. SBi was the first company to focus purely on small bones & joints by integrating established companies and professionals in the field. It offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in the small bones & joints.
SBi has facilities in New York, NY, Morrisville, PA, Bourg-en-Bresse, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in 46 countries.
This news release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting SBi's business including increased competition; the ability of SBi to expand its operations and to attract and retain qualified professionals; technological obsolescence; general economic conditions; and other risks.