5 Clinical Trials for Various Conditions
In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.
There are approximately 250,000 hip fractures in the US every year, and intertrochanteric (IT) fractures (fractures that occur just below the femoral head) account for nearly half of these fractures. The use of intramedullary (IM) nails for fixation of IT femur fractures has become a well-accepted and increasingly more common procedure among orthopaedic traumatologists, and is standard of care at our institution. While advancements in intramedullary nail fixation have made it a relatively efficient procedure, the placement of the lag screw into the femoral head still remains a challenging step in the procedure. Inaccurate placement can lead to screw cut-out, one of the most commonly reported complications with IM nail fixation. Previous work has shown that the lag screw position is an important factor in reducing screw cut-out. This step of the procedure can be time demanding and often requires several intraoperative radiographs for accurate placement. Recently developed computer-assisted navigation systems provide surgeons with the ability to track screw placement in real-time. This could allow for improved screw placement and potentially reduce radiation exposure to the patient and surgeon. To date, the potential advantages of computer-assisted navigation have not been examined. The primary objective of this study is to examine whether the use of Stryker's ADAPT computer-assisted navigation for Gamma nail fixation can result in improved lag screw placement. The secondary objective is to examine whether the use of the ADAPT for Gamma nail fixation can reduce intraoperative radiation exposure.Our hypothesis is that there is a difference in the lag screw placement (i.e. tip to apex distance measurement) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation. Additionally, we hypothesize that there is a difference in radiation exposure (i.e. fluoroscopy time) between procedures using the ADAPT system versus the conventional technique for Gamma nail fixation.
The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.