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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia fracture? Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.

Official Title

Intramedullary Nail Versus Plate Fixation Re-Evaluation Study in Proximal Tibial Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (IMPRESS)

Details

The study is a multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia 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). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.

Keywords

Tibial Fractures tibia fracture proximal tibia Fractures, Bone

Eligibility

You can join if…

Open to people ages 18 years and up

  • Skeletally mature,
  • Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular 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

You CAN'T join if...

  • Tibial shaft fractures 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,
  • Pathological fractures,
  • 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,
  • Immunocompromised,
  • Unable to comply with postoperative rehabilitation protocols or instructions (i.e.head injured or mentally impaired),
  • Current or impending incarceration,
  • Unlikely to follow-up in surgeon's estimation.

Locations

  • University of California-San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • University of California at Davis accepting new patients
    Davis, California, 95616, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Medical Center
ID
NCT00429585
Lead Scientist
Saam Morshed
Study Type
Interventional
Last Updated
December 15, 2016
I’m interested in this study!