A Prospective Randomized Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures

Brief description of study

The purpose of this study is to see if a resorbable bone filler with antibiotic, called CERAMENT|G, is safe and works well to promote bone healing and prevent infection in people with open (exposed bone) fractures of the tibia (long bone in the lower leg) compared to standard surgical and medical care. The treatment of open fractures of the tibia may be complicated by delayed healing, which is more likely to occur when there is an infection. When healing is delayed or infection develops, another surgical procedure may be needed. Due to bone loss or gaps in your bones as a result of your leg fracture, some surgeons use bone graft substitutes to fill these spaces. BONESUPPORT (the Sponsor) has developed a resorbable ceramic bone graft substitute that is similar to other bone void fillers except that it contains a drug called gentamicin (an antibiotic). Gentamicin is a well-known antibiotic medication that is currently used to prevent or treat serious bacterial infections. CERAMENT|G is intended to fill gaps in the bone to promote bone healing and,by supplying gentamicin directly to the bone and surrounding tissue for up to a month, help prevent infection. CERAMENT|G is considered an investigational device because it is not approved by the US Food and Drug Administration (FDA) for commercial use in the U.S. CERAMENT|G device has been studied extensively in animals, and has regulatory approval (CE Mark) and is sold commercially in Europe.

Clinical Study Identifier: s17-00165
ClinicalTrials.gov Identifier: NCT02820363

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