3 Clinical Trials for Various Conditions
The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint. The investigators hope to learn the following objectives from this study 1. Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 2. Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 3. Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 4. Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation
Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an ankle fracture in which both the tibia and the fibula are broken. This would alleviate the need for another incision, plate, and screws to repair the fibula. The purpose of this study is to help determine if surgically repairing only the tibia fracture will lead to equivalent clinical outcomes when compared with surgical repair of both bones. The hypothesis of this study is that operative stabilization of the medial malleolus fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the ankle, will lead to equivalent clinical outcomes and functional scores as those treated with operative stabilization of both malleoli and/or all malleoli.
This study aims to 1) characterize skeletal muscle pH during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.