Ring fixators vs. internal fixation: which is better for severe leg fractures?
NCT ID NCT01494519
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 442 people with severe open fractures of the shin bone (tibia). It compared two surgical approaches: using a modern ring external fixator (a frame outside the leg) versus internal fixation (a metal rod or plate placed inside the bone). The main goal was to see which method leads to fewer hospital readmissions for complications like infection or bone healing problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Surgery with an external ring fixator or internal fixation (nail/plate)
- What this could lead to
- If successful, this could show which surgical method reduces complications and re-hospitalizations for severe open tibia fractures.
- What could go wrong
- This is a completed Phase 3 trial, but results may not apply to all fracture types or settings. Individual outcomes vary by injury severity and patient factors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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442 people
The number who actually took part.
- Start date
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Jul 2011
- Finished
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Sep 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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). 2. Ages 18 - 64 years inclusive 3. 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: 1. Patients may have co-existing non-tibial infection, with or without antibiotic treatment. 2. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections. 3. Patients may have a traumatic brain injury. 4. Patients may be treated initially with a temporary external fixator prior to randomization. 5. 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. 6. 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. 7. Fractures may have a gap after debridement of any size, including no gap. Exclusion Criteria: 1. Patients presenting with a traumatic amputation of the tibia 2. Patients already received definitive fixation with an IM nail, plate or ring fixator prior to study enrollment 3. Tibia already infected as diagnosed by a surgeon and currently receiving treatment for it 4. Patient speaks neither English nor Spanish 5. Patient is a prisoner 6. Patient has been diagnosed with a severe psychiatric condition 7. Patient is intellectually challenged without adequate family support 8. Patient lives outside the catchment area 9. Non-ambulatory patient due to an associated complete spinal cord injury 10. Non-ambulatory before the injury due to a pre-existing condition. 11. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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Carolinas Medical Center
Charlotte, North Carolina, 28232, United States
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Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
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Eskenazi Health
Indianapolis, Indiana, 46202, United States
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Florida Orthopaedic Institute, Tampa General Hospital
Tampa, Florida, 33606, United States
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Geisinger Health System
Danville, Pennsylvania, 17822, United States
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Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, 55415, United States
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MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
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Mission Hospital
Asheville, North Carolina, 28801, United States
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Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
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Naval Medical Center San Diego
San Diego, California, 92134, United States
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Orlando Regional Medical Center
Orlando, Florida, 32806, United States
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OrthoIndy / Methodist Hospital
Indianapolis, Indiana, 46202, United States
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Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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Regions Hospital
Saint Paul, Minnesota, 55101, United States
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San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234-6315, United States
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St Vincent Hospital
Indianapolis, Indiana, 46260, United States
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St. Louis Medical Center
St Louis, Missouri, 63110, United States
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Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
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UCSF Medical Center
San Francisco, California, 94115, United States
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UT Health: The University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201, United States
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University of Miami Ryder Trauma Center
Miami, Florida, 33101, United States
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University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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University of Texas Health Science Center, San Antonio
San Antonio, Texas, 78229, United States
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of Wisconsin
Madison, Wisconsin, 53705, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1070, United States
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Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States