Assessment of Fixation Strategies for Severe Open Tibia Fractures

Completed · Phase 3

Conditions studied: Severe Open Fractures of the Tibia (Shin) Bone

In brief

The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.

Key facts

Study ID

NCT01494519

Run by

Major Extremity Trauma Research Consortium

People needed

442

Starts

2011-07-01

Expected to finish

2018-09-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All open tibia fractures meeting at least one of 1 the following criteria:
• Diaphyseal or metaphyseal Type IIIB (Gustilo IIIB Fractures are open fractures that require either a rotational or free flap for coverage of a soft tissue defect).
• Diaphyseal or metaphyseal Type IIIA where extensive contamination or muscle damage (e.g. all military injuries from IED) precludes nail/plate placement at first debridement.
• Diaphyseal or metaphyseal Type IIIA, where injury would have been classified as a IIIB, but because enough muscle was removed, the skin could be closed.
• Diaphyseal or metaphyseal Type IIIA, where after debridement, bone gap is greater than 1cm.
• Diaphyseal or metaphyseal Type IIIA, where fasciotomies were performed for impending or diagnosed compartment syndrome, and wounds could not be closed primarily (i.e. needs skin grafting).
• Ages 18 - 64 years inclusive
• Study fracture is suitable for limb salvage using either a modern ring external fixator or internal fixation (internal fixation =locked intramedullary nail or plate).
• Inclusion notes:
• Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
• Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
• Patients may have a traumatic brain injury.
• Patients may be treated initially with a temporary external fixator prior to randomization.
• Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive fixation was not performed prior to entrance into the study.
• Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
• Fractures may have a gap after debridement of any size, including no gap.

You may not qualify if…

• Patients presenting with a traumatic amputation of the tibia
• Patients already received definitive fixation with an IM nail, plate or ring fixator prior to study enrollment
• Tibia already infected as diagnosed by a surgeon and currently receiving treatment for it
• Patient speaks neither English nor Spanish
• Patient is a prisoner
• Patient has been diagnosed with a severe psychiatric condition
• Patient is intellectually challenged without adequate family support
• Patient lives outside the catchment area
• Non-ambulatory patient due to an associated complete spinal cord injury
• Non-ambulatory before the injury due to a pre-existing condition.
• Complex pilon and plateau fractures. The study tibia fracture may have extension into the joint surface, but should primarily be a metaphyseal or diaphyseal fracture and not have an ipsilateral tibial plateau or pilon fracture.Contralateral tibial plateau and pilon fractures are allowed

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Naval Medical Center San Diego — San Diego, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• University of Miami Ryder Trauma Center — Miami, Florida, United States
• Orlando Regional Medical Center — Orlando, Florida, United States
• Florida Orthopaedic Institute, Tampa General Hospital — Tampa, Florida, United States
• Eskenazi Health — Indianapolis, Indiana, United States
• OrthoIndy / Methodist Hospital — Indianapolis, Indiana, United States
• St Vincent Hospital — Indianapolis, Indiana, United States
• University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Hennepin County Medical Center / Minneapolis — Minneapolis, Minnesota, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• St. Louis Medical Center — St Louis, Missouri, United States
• Mission Hospital — Asheville, North Carolina, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Geisinger Health System — Danville, Pennsylvania, United States
• Penn State University M.S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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