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Comparison Between LISS Plating and Intramedullary (IM) Nailing for Supracondylar Femur Fractures

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00578019
First received: December 18, 2007
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Supracondylar Femur Fracture
Procedure: IM Nailing
Procedure: LISS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Comparison Between Less Invasive Stabilization System (LISS) Plating and Intramedullary Nailing for the Treatment of Supracondylar Femur Fractures

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • The primary outcome measure is complete healing of the femur fracture [ Time Frame: Clinical outcomes will be evaluated at weeks 12, 26, and 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 1999
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1, A Procedure: 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.
Other Name: Smith & Nephew Supracondylar Nail
Experimental: 2, B
Group B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA).
Procedure: LISS
Group B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA).
Other Name: Synthes LISS

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type A or C supracondylar femur fracture
  • Adult patients (19 years or older)

Exclusion Criteria:

  • Patients unable or unwilling to comply with follow-up gait, radiographic, and clinical evaluations necessary to complete the study
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578019

Locations
United States, Alabama
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: James P Stannard, MD The University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: James P. Stannard, MD, Professor of Surgery, Assoc. Director of Orthopaedic Surgery, The University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00578019     History of Changes
Other Study ID Numbers: F990825010, AO Foundation FORK 99S83
Study First Received: December 18, 2007
Last Updated: September 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Comparative
Supracondylar Femur Fracture
Intramedullary nailing
Less Invasive Stabilization System (LISS) Plating

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014