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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02064595
Other study ID # Ortofmabc1
Secondary ID
Status Completed
Phase N/A
First received February 3, 2014
Last updated February 18, 2014
Start date January 2011
Est. completion date January 2013

Study information

Verified date February 2014
Source Faculdade de Medicina do ABC
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
External fixator
Treatment with external fixation
Intramedullary nail
Fracture treated with intramedullary nail

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fabio lucas rodrigues

Outcome

Type Measure Description Time frame Safety issue
Other Infection Productive fistula, phlogistics signals 1 year No
Primary Bone healing bone formation in 3 cortical through the fracture in x ray One year No
Secondary Quality of life SF 36 1 year No
See also
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Recruiting NCT05615844 - Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy Phase 3
Not yet recruiting NCT06288139 - Management of Open Fracture Tibia in Teenagers
Not yet recruiting NCT05766670 - Intramedullary Calcium Sulfate Antibiotic Depot Phase 3
Not yet recruiting NCT04072094 - Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture N/A