1. Problem Statement Project Proposal Design a device that will reduce the time of a medial malleolus fracture repair surgery Design a device that simplifies the procedure for the surgeon Design a device that will eliminate complication due to imprecise placement of screws The device should form a sturdy bond with the tibia and provide a compressive force on the fractured bone The device should also align the guide wires that will be inserted through the fracture to stabilize the bone before screw placement Ankle Fracture Facts 550,000 ankle fractures each year in the United States Caused by auto accidents, falls, sports injuries, miss-stepping. Approximate cost of Ankle Surgery: $1325 Approximate length of Ankle Surgery: 1 hour Impact Shortening the time of surgery and making the procedure simpler will reduce risks and the cost of surgery Device Design Base Plate Secures to the tibia Two guide wire orientations Connects to length adjuster via ball joint Length Adjuster Three components (1)Length adjuster base (2)Thumb screw (3)Length adjuster rod Rotation of screw transmitted into linear motion Allows the device to compress and uncompress by 1” Connects to the end effector via ball joint End Effector Securely holds fractured piece to tibia Two parallel holes ensure precise screw placement Two piece assembly allows surgeon to complete surgery without removing entire device Four spikes to grip bone Purpose Problems with Current Solution Securing fractured bone to tibia with clamps takes multiple steps and cannot withstand much stress Screw and guide wires must be parallel which can be hard to accomplish by hand Project Goals Create a device that will quickly and securely affix to the tibia Create a device that can be easily adjusted and aligned Create a device that will fit within the surgical envelope Create a device which is easily sterilizable Safety and Cost Estimates Safety Concerns Device can withstand stresses of surgery Device can be disassembled for easy sterilization Cost Estimates Prototype cost: $600 Final product cost: greater than $600 Cost Savings per surgery assuming 15 minute reduction in operating room time: $325 per surgery Time to recover initial cost: approximately 3 surgeries Accomplishments Create design that solves current problems Create Prototype of device Device Features Stainless Steel Reusable 3” length fully uncompressed ¾” width Two ball joints Modular end effector Background Current Solution The surgeon uses a bone clamp to hold the fractured bone in place. Because of the steep angle of the tibia surface, the surgeon usually drills a small hole to hook the bone clamp into in order to get a firm grip on the bone. Once the bone is held in place, two guide wires are independently pushed through the fractured bone. This process is done by hand so correct placement and angle of theses wires are visually estimated. Lastly, two cannulated bone screws are then screwed over the guide wires to form a permanent fixation Our Device Ankle Alignment Clamp for Medial Malleolus Fracture Garrett Sauter 1, Trey Kendall 2 Advisors: Dave Martinez 3, Dr. William DeVries 4 1 Biomedical Engineering Department - Vanderbilt University, 2 Mechanical Engineering Department - Vanderbilt University, Zimmer 3, Tennessee Orthopedic Alliance 4 Exploded View Medial Malleolus fracture Bone Clamp Medial Malleolus post surgery Base plate Length Adjuster End Effector References http://www.springerlink.com/content/57lx94q6ck384ruc/fulltext.pdf Assembled View Prototype with Tibia Side View Above View