Supracondylar Femur Fracture Clinical Trial
Official title:
Prospective Comparison Between Less Invasive Stabilization System (LISS) Plating and Intramedullary Nailing for the Treatment of Supracondylar Femur Fractures
The purpose of this study is to compare patient outcomes for the Less Invasive Stabilization System (LISS) (Synthes {USA}, Paoli, PA, USA), a minimally invasive plating system used in the treatment of supracondylar femur fractures, with patient outcomes for the Supracondylar Nail (Smith & Nephew Inc, Memphis, TN, USA), a retrograde intramedullary nail.
All patients who meet the inclusion and exclusion criteria will be randomized into one of
two treatment groups. Group A patients will be treated with retrograde intramedullary
nailing of the fracture with supplemental screw fixation of the articular portion of the
fracture if needed. The Richards supracondylar nail (Smith & Nephew Richards, Memphis, TN,
USA) will be utilized. Group B patients will have their fracture stabilized with the LISS
plates (Synthes [USA], Paoli, PA, USA). Supplemental screw fixation of the articular portion
of the fracture will occur, if needed. Postoperative care will not be any different than the
postoperative care of any other patient undergoing internal fixation of a complex fracture
around the knee and based on the patient's overall condition.
Surgical Protocol: After the anesthesia staff has administered general anesthesia, the
patient will be positioned on the operating room table as described by the intraoperative
technique guide or according to the patient's injury and the surgeon's preference. The
patient will be prepped and draped in the usual and customary manner for orthopaedic
procedures of the lower extremities. The image intensifier will be available for
intraoperative fluoroscopy. The manufacturer's surgical technique guide will be used
intraoperatively for implantation of the LISS device and the supracondylar nail. The
surgical wound will be closed according to the surgeon's preference. A drainage device may
be used if indicated. Routine dressings will be applied. In all instances, immediate
postoperative radiographs will be taken to document adequate reduction and fixation.
Neurovascular evaluation of the extremity will be performed and documented when the patient
emerges from the anesthetic. The patient will be discharged from the recovery room to the
postoperative unit when they have met discharge criteria. Routine postoperative orders will
be followed until discharge from the hospital.
Patients will be followed in the orthopaedic clinic at predetermined intervals following
surgery. The clinic visits will include anterior-posterior and lateral radiographs of the
affected extremity and a clinical examination. The patient will also complete the SF-36
(Appendix 1) and a pain scale (Appendix 2). This data will be used to compare the outcomes
obtained with the two devices. Clinical follow-up will occur at 2, 4, 8, 12, 18, 26, and 52
weeks following surgery. Radiographs will be obtained at 4, 8, 12, 18, 26, and 52 weeks
postoperatively. Patients will complete pain scales at 4, 8, 12, 18, 26, and 52 weeks after
surgery. Clinical outcomes will be evaluated at weeks 12, 26, and 52.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment