Clinical trial NCT01494519: Assessment of Fixation Strategies for Severe Open Tibia Fractures
Official title: A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures:Modern Ring External Fixators Versus Internal Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Open Fractures of the Tibia (Shin) Bone
Keywords: External ring fixation
internal fixation
traumatic tibia fracture
Lead sponsor: Major Extremity Trauma Research Consortium
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-12-19
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Severe open fractures of the tibia (shin) bone are difficult to treat and are associated with high rates of infection and other complications. There is controversy regarding the best treatment, particularly in fractures with large wounds from trauma. The two current standard treatment options are to place an internal fixation device (a nail or plates with screws) or to use a device with pins that stick out of the skin and attach to rings outside the body (modern ring external fixator). It is unknown which of these standard of care treatment options will result in lower complication rates and better function of the leg.

Our goal is to perform a multi-center randomized controlled trial of the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures. Patients who refuse randomization have the option of participating in a prospective observational study and the treatment is decided by the surgeon and patient.

Primary Aim: To compare the outcomes associated with modern ring external fixators versus standard internal fixation techniques in treating "severe" open tibia shaft or metaphyseal fractures with or without a bone defect of any size.

Primary Hypothesis: Among patients with open tibia shaft or metaphyseal fractures (with or without a bone defect of any size), the rate of re-hospitalization for major limb complications will be lower for patients treated with ring fixators than those treated with standard internal fixation.

Secondary Hypotheses: Among patients with open tibia shaft or metaphyseal fractures (with or without a bone defect of any size), the overall rate of infections will be lower for patients treated with ring fixators than those treated with standard internal fixation. Measures of fracture healing, limb function, and patient reported outcomes (including pain) will be as good or better among patients treated with ring fixators than those treated with standard internal fixation.

Secondary Aim #1: To determine the percentage of Gustilo IIIB open tibia shaft fractures that can be treated successfully (i.e. without amputation) without a soft tissue flap secondary to the use of ring external fixators.

Secondary Aim #2: To determine the two-year treatment costs associated with fixation of "severe" open tibia shaft or metaphyseal fractures (with or without a bone defect of any size) using modern ring external fixators versus standard internal fixation techniques.

Secondary Aim #3: To determine patient reported levels of satisfaction with the fixation method and overall treatment and to compare satisfaction between the two treatment groups.

Eligibility criteria: 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

Primary outcomes:
measure: Re-hospitalization for Complication.
timeFrame: 2 years
Secondary outcomes:
measure: Infection.
timeFrame: 2 years
measure: Fracture Healing.
timeFrame: 2 years
measure: Limb Function.
timeFrame: 2 years
measure: Patient Reported Outcome and Quality of Life.
timeFrame: 2 years
measure: Pain
timeFrame: 2 years
measure: Satisfaction with treatment
timeFrame: 2 years
measure: Health Care Costs
timeFrame: 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Miami
country: United States
facility: University of Miami Ryder Trauma Center
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: Florida Orthopaedic Institute, Tampa General Hospital
state: Florida
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
city: Indianapolis
country: United States
facility: OrthoIndy / Methodist Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St Vincent Hospital
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland, R Adams Cowley Shock Trauma Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center / Minneapolis
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Medical Center
state: Missouri
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State University M.S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Houston
country: United States
facility: UT Health: The University of Texas Health Science Center at Houston Medical School
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center, San Antonio
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Major Extremity Trauma Research Consortium
name: Lisa Reider, MHS, PhD
role: STUDY_DIRECTOR
References: