Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail
NCT ID: NCT02064595
Last Updated: 2014-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2011-01-31
2013-01-31
Brief Summary
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Detailed Description
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As inclusion criterion, the investigators considered those with shaft compound fracture of the tibia (occurring two inches below the knee and two inches above the ankle), that per the classification Gustillo and Anderson were grades I, II, and IIIA, in patients with a mature skeleton.
The presence of extensive skin lesions and soft tissue or arterial injury requiring surgical repair (Grades IIIB and C) in the initial care, other fractures with the exception of the fibula, or the presence of wounds with signs of infection in the period between the accident and definitive surgery, were used as exclusion criteria.
The patients will be treated in two ways, biplanar external fixator (Group I) and locked intramedullary reamed nail in the tibia (Group II), being divided into these groups by simple randomization.
During initial care in the emergency room, antibiotic prophylaxis, cleaning, debridement, and external splinting of the fracture were performed by staff on duty. There was no interference with respect to the type of assembly to be used in the initial care, leaving the doctor on duty free to use the type of external fixators which he is most used to.
Patients remained hospitalized and received first-generation cephalosporin and dressing of the wound daily. In the 4th to the 7th postoperative day after the initial procedure, the patient underwent another surgery to reassemble the biplanar external fixation or to convert to the locked intramedullary reamed nail.
External fixation consists of the biplanar assembly with six Schanz pins of six millimeters. The placement of these follows the sequence: two proximal to the fracture in different planes and two distal similar to the first. The investigators performed reduction and placement of two bars, one medial and one lateral. Assessed by radiography, two more pins were then introduced into the medial rod, ending with the fixation of a tube-to-tube rod at the level of the fracture. For fixation by locked intramedullary reamed nail, the access path of introduction used was through the patellar tendon, with the knee flexed at 100 degrees on a radiotransparent table.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intramedullary nail
Fractures treated with intramedullary reamed nail
Intramedullary nail
Fracture treated with intramedullary nail
External fixator
Tibial fractures treated with biplanar external fixation
External fixator
Treatment with external fixation
Interventions
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External fixator
Treatment with external fixation
Intramedullary nail
Fracture treated with intramedullary nail
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fabio lucas rodrigues
OTHER
Responsible Party
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Fabio lucas rodrigues
Md
Other Identifiers
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Ortofmabc1
Identifier Type: -
Identifier Source: org_study_id
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