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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Orthopedics / Fracture Repair
Title   Mangement of fracture of the distal femur (Orthopedics / Fracture Repair)
Description   Individuals sustaining a fracture of the distal femur will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group).
IRB Number   Pro335
Inclusion/Notes   INCLUSION:
  • Skeletally mature.

  • Fracture of the metaphyseal distal femur with or without intra­articular extension and with or without a TKA.

  • Fracture requiring operative treatment amenable to either IM nail or plate.

  • Surgeon agreed to randomize patient.

  • Informed consent obtained.

  • Patient is English speaking.

EXCLUSION:
  • Fracture of the metaphyseal distal femur with intraarticular comminution.

  • Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair.

  • Pathological fracture.

  • Known metabolic bone disease.

  • Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating.

  • Symptomatic knee arthritis.

  • Soft tissue injuries compromising either treatment method with nail or plate.

  • Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures.

  • Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee .

  • Immunocompromised.

  • Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired).

  • Current or impending incarceration.

  • Unlikely to follow­up in surgeon’s estimation.
Status   Active - not Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Cory Alan Collinge MD
Contact Name   Tara Weaver
Phone   (817) 820-4306

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