WARSAW, Ind.--()--Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, announced today that enrollment in the Company’s SternaLock® Blu clinical trial has begun. The SternaLock® Blu clinical trial is a prospective, randomized, controlled, multicenter trial that will compare patients whose sternum is closed with conventional wire cerclage to patients whose sternum is closed with Biomet’s SternaLock® Blu Primary Closure System to evaluate sternal bone healing following a full median sternotomy. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. The study will also compare the economic costs between the two groups.
Dr. Keith Allen, who enrolled the first patient in the SternaLock® Blu study at Saint Luke’s Hospital in Kansas City, Missouri, stated: “Biomet’s commitment to clinical research in the area of sternal closure after heart surgery is important for advancing patient care. We are excited that enrollment in the SternaLock® Blu study has started and we look forward to adding to the pioneering clinical research that Biomet has already conducted in this space.”
The SternaLock® Blu study is a continuation of Biomet's commitment to studying sternal closure. In December 2012, Biomet completed a prospective, randomized, controlled, multicenter clinical trial that compared bone healing between patients whose sternum was closed with wire to patients whose sternum was plated using Biomet’s first generation sternal closure system, the SternaLock® Primary Closure System. The study was published in the December 2012 issue of The Annals of Thoracic Surgery.
Investigators in the SternaLock® Blu clinical trial plan to enroll 236 patients from up to 12 leading cardiac centers across the United States. The results of the trial are expected to provide important information about the use of rigid sternal fixation. Additional details of the trial can be found by visiting www.clinicaltrials.gov and entering the trial identifier code NCT01783483. For more information about Biomet’s SternaLock® Blu Primary Closure System, including indications, contraindications, risks, and warnings, please see “warnings and precautions” at www.sternalock.com.
Biomet, Inc. and its subsidiaries design, manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non-surgical therapy. Biomet’s product portfolio encompasses large joint reconstructive products, including orthopedic joint replacement devices, and bone cements and accessories; sports medicine, extremities and trauma products, including internal and external orthopedic fixation devices; spine and bone healing products, including spine hardware, spinal stimulation devices, and orthobiologics, as well as electrical bone growth stimulators and softgoods and bracing; dental reconstructive products; and other products, including microfixation products and autologous therapies. Headquartered in Warsaw, Indiana, Biomet and its subsidiaries currently distribute products in approximately 90 countries.
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