An interventional study of IM Nailing and LISS in Supracondylar Femur Fracture, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-10-01.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 80 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
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Exclusion Criteria:
Procedure: IM Nailing
Group B patients will have their fracture stabilized with the LISS plates (Synthes \[USA\], Paoli, PA, USA).
Procedure: LISS
Patients randomized to Arm 1, A will be treated with a retrograde intramedullary nailing of the femur fracture utilizing the Smith \& Nephew supracondylar nail.
Also known as: Smith & Nephew Supracondylar Nail
Group B patients will have their fracture stabilized with the LISS plates (Synthes \[USA\], Paoli, PA, USA).
Also known as: Synthes LISS
The primary outcome measure is complete healing of the femur fracture
Time frame: Clinical outcomes will be evaluated at weeks 12, 26, and 52
Secondary outcome is to compare the time and quality of healing of the femur fracture
Time frame: Will be evaluated at weeks 12, 26 and 52
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham