Alphatec Spine, Inc. (Alphatec), is planning to complete clinical trial entitled “Evaluation of Safety and Effectiveness of the OsseoFix Spinal Fracture Reduction System in Treating Spinal Compression Fracture” for OsseoFix by March 2011. The objective of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US. The phase III study is being conducted at up to 15 investigational centers in the US.
The non-randomized, open label, historical control, parallel assignment, safety/efficacy study is ongoing, but not recruiting participants. The trial has approximately enrolled 125 participants with one or two vertebral compression fractures between levels T6 and L5 implanted with the investigational device. The principal investigatirs are James Yue, MD Yale University and Daniel Bennett, MD Integrative Treatment Centers.
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+ polymethylmethacrylate (PMMA) bone cement. It restores biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.