Open tíbia FractureNCT02064595
Open Tibia Fractures a Comparative Study Between Biplane External Fixator and Locked Intramedullary Nail
A study testing External fixator and Intramedullary nail in people with Open tíbia Fracture, run by Fabio lucas rodrigues.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open tíbia Fracture
- What is being tested?
- External fixator and Intramedullary nail
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: TREATMENT OF EXPOSED FRACTURES OF TIBIA: A COMPARATIVE STUDY BETWEEN BIPLANE EXTERNAL FIXATOR AND LOCKED INTRAMEDULLARY NAIL
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.
Read the 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.
- Conditions
- Open tíbia Fracture
- Being tested
- External fixator, Intramedullary nail
- Keywords
- Tibial fractures., Fracture fixation., External fixators., Intramedullary., Quality of life.
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External fixatorProcedure or surgery
Treatment with external fixation
Intramedullary nailProcedure or surgery
Fracture treated with intramedullary nail
| Study group | Role | What they receive |
|---|---|---|
| Intramedullary nail | Other | Fractures treated with intramedullary reamed nail Receives: Procedure: Intramedullary nail |
| External fixator | Active comparator | Tibial fractures treated with biplanar external fixation Receives: Procedure: External fixator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing
bone formation in 3 cortical through the fracture in x ray
Measured: One year
Secondary outcomes (1)
Quality of life
SF 36
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open tíbia FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabio lucas rodrigues
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabio lucas rodrigues, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064595
- Sponsor's protocol ID
- Ortofmabc1
- Status last verified
- Feb 2014
- First submitted
- 3 Feb 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREATMENT OF EXPOSED FRACTURES OF TIBIA: A COMPARATIVE STUDY BETWEEN BIPLANE EXTERNAL FIXATOR AND LOCKED INTRAMEDULLARY NAIL
- ClinicalTrials.gov ID
- NCT02064595
- Acronym / sponsor ID
- Ortofmabc1
- Conditions
- Open tíbia Fracture
- Keywords
- Tibial fractures., Fracture fixation., External fixators., Intramedullary., Quality of life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fabio lucas rodriguesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramedullary nail | Other | Procedure: Intramedullary nailFractures treated with intramedullary reamed nail |
| External fixator | Active comparator | Procedure: External fixatorTibial fractures treated with biplanar external fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External fixatorTreatment with external fixation | Procedure or surgery | External fixator |
| Intramedullary nailFracture treated with intramedullary nail | Procedure or surgery | Intramedullary nail |
Primary outcome
Bone healing
Time frame: One year
bone formation in 3 cortical through the fracture in x ray
1 secondary outcome
Quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing External fixator and Intramedullary nail in people with Open tíbia Fracture, run by Fabio lucas rodrigues.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone healing (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.