Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail
Primary Purpose
Open tíbia Fracture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
External fixator
Intramedullary nail
Sponsored by
About this trial
This is an interventional treatment trial for Open tíbia Fracture focused on measuring Tibial fractures., Fracture fixation., External fixators., Intramedullary., Quality of life.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Intramedullary nail
External fixator
Arm Description
Fractures treated with intramedullary reamed nail
Tibial fractures treated with biplanar external fixation
Outcomes
Primary Outcome Measures
Bone healing
bone formation in 3 cortical through the fracture in x ray
Secondary Outcome Measures
Quality of life
SF 36
Full Information
NCT ID
NCT02064595
First Posted
February 3, 2014
Last Updated
February 18, 2014
Sponsor
Fabio lucas rodrigues
1. Study Identification
Unique Protocol Identification Number
NCT02064595
Brief Title
Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail
Official Title
TREATMENT OF EXPOSED FRACTURES OF TIBIA: A COMPARATIVE STUDY BETWEEN BIPLANE EXTERNAL FIXATOR AND LOCKED INTRAMEDULLARY NAIL
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fabio lucas rodrigues
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this research is to prospectively evaluate a group of patients with shaft compound fracture of the tibia, treated with a biplanar external fixator or locked intramedullary reamed nail. The investigators evaluate the quality of life, bone healing and postoperative complications.
Detailed Description
68 patients will be followed for a minimum of 12 months and a maximum of 24 months.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open tíbia Fracture
Keywords
Tibial fractures., Fracture fixation., External fixators., Intramedullary., Quality of life.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intramedullary nail
Arm Type
Other
Arm Description
Fractures treated with intramedullary reamed nail
Arm Title
External fixator
Arm Type
Active Comparator
Arm Description
Tibial fractures treated with biplanar external fixation
Intervention Type
Procedure
Intervention Name(s)
External fixator
Intervention Description
Treatment with external fixation
Intervention Type
Procedure
Intervention Name(s)
Intramedullary nail
Intervention Description
Fracture treated with intramedullary nail
Primary Outcome Measure Information:
Title
Bone healing
Description
bone formation in 3 cortical through the fracture in x ray
Time Frame
One year
Secondary Outcome Measure Information:
Title
Quality of life
Description
SF 36
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Infection
Description
Productive fistula, phlogistics signals
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail
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