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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Orthopedics / Fracture Repair
Title   Inter-locking nail or Nails versus Plate attachement (Orthopedics / Fracture Repair)
Description   This study looks at two (2) types of surgical treatments to hold the bones while healing. This study is being done to determine if one procedure is better that the other.
IRB Number   Pro261
Inclusion/Notes   INCLUSION:
  • Skeletally mature.

  • Extra­articular fracture of the proximal tibia extending into the metaphyseal with or
    without intra­articular extension not requiring open reduction with complete AP and
    lateral radiographs.

  • Major fracture line not closer than 4cm from the proximal tibial articular surface.

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

  • Surgeon agreed to randomize patient.

  • Informed consent obtained.

  • Patient is English speaking.

  • Patients may have undergone previous surgical interventions either for placement of a spanning external fixator and/or debridement of open fracture wounds. This may have been done at the eventual treating institution or not. That is, the patient could represent a referral of a proximal tibia fracture, which had undergone previous debridement and / or spanning external fixator placement elsewhere.

EXCLUSION:
  • Tibial shaft fracture not amenable to intramedullary nailing (i.e. fracture is less than 4 cm from joint surface).

  • Fracture of the proximal tibia with intraarticular extension requiring open reduction.

  • Known metabolic bone disease.

  • Separate displaced tibial tubercle fragment.

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

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

  • Compartment syndrome of the leg diagnosed preoperatively 8. Pathological fracture.

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

  • Symptomatic knee arthritis.

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

  • Contralateral proximal tibia 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   Completed
Location   Texas Health Harris Methodist Hospital Fort Worth
Principal Name    Cory Alan Collinge MD
Contact Name   Tara Weaver
Phone   (817) 820-4306

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