Comparison Between LISS Plating and Intramedullary (IM) Nailing for Supracondylar Femur Fractures
NCT ID: NCT00578019
Last Updated: 2013-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
1999-12-31
2005-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1, A
IM Nailing
Patients randomized to Arm 1, A will be treated with a retrograde intramedullary nailing of the femur fracture utilizing the Smith \& Nephew supracondylar nail.
2, B
Group B patients will have their fracture stabilized with the LISS plates (Synthes \[USA\], Paoli, PA, USA).
LISS
Group B patients will have their fracture stabilized with the LISS plates (Synthes \[USA\], Paoli, PA, USA).
Interventions
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IM Nailing
Patients randomized to Arm 1, A will be treated with a retrograde intramedullary nailing of the femur fracture utilizing the Smith \& Nephew supracondylar nail.
LISS
Group B patients will have their fracture stabilized with the LISS plates (Synthes \[USA\], Paoli, PA, USA).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult patients (19 years or older)
Exclusion Criteria
* Patients are not able or willing to give informed consent and/or have no responsible family member willing to give consent
* Patients with a disease entity or condition that totally precludes the possibility of bony fusion or patients undergoing drug therapy that prevents bony healing
* Mentally retarded persons
* Mentally disabled individuals
* Prisoners
* Pregnant women
19 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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The University of Alabama at Birmingham
Principal Investigators
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James P Stannard, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Alabama at Birmingham
Locations
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The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States
Countries
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References
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Kayali C, Agus H, Turgut A. Successful results of minimally invasive surgery for comminuted supracondylar femoral fractures with LISS: comparative study of multiply injured and isolated femoral fractures. J Orthop Sci. 2007 Sep;12(5):458-65. doi: 10.1007/s00776-007-1156-8. Epub 2007 Sep 28.
Boldin C, Fankhauser F, Hofer HP, Szyszkowitz R. Three-year results of proximal tibia fractures treated with the LISS. Clin Orthop Relat Res. 2006 Apr;445:222-9. doi: 10.1097/01.blo.0000203467.58431.a0.
Stannard JP, Wilson TC, Volgas DA, Alonso JE. The less invasive stabilization system in the treatment of complex fractures of the tibial plateau: short-term results. J Orthop Trauma. 2004 Sep;18(8):552-8. doi: 10.1097/00005131-200409000-00012.
Other Identifiers
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AO Foundation FORK 99S83
Identifier Type: -
Identifier Source: secondary_id
F990825010
Identifier Type: -
Identifier Source: org_study_id