Minimally Invasive Locking Plate Fixation vs Reamed Intramedullary Nail Fixation on Patients With Open Tibia Fracture
NCT ID: NCT04072094
Last Updated: 2020-05-12
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2020-06-30
2025-06-30
Brief Summary
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Detailed Description
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This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Minimally Invasive Locking Plate Fixation
Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
Minimally Invasive Locking Plate Fixation
Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
Intramedullary Nail Fixation
Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.
Intramedullary Nail Fixation
Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.
Interventions
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Minimally Invasive Locking Plate Fixation
Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
Intramedullary Nail Fixation
Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Open diaphyseal fracture
* Gustilo-Anderson Type I, II, IIIA
Exclusion Criteria
* Gustilo-Anderson Type IIIB,IIIC
* Patients with concomitant fractures in the ipsilateral limb
* The patient is unable to medically tolerate general anesthesia
* The patient is unable to provide informed consent or comply with completing questionnaires
* Tibia already infected as diagnosed by a surgeon
* The patient has been diagnosed with a severe psychiatric condition
18 Years
60 Years
ALL
No
Sponsors
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Taizhou Hospital
OTHER
Ningbo No.2 Hospital
OTHER
The First People's Hospital of Huzhou
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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z2gk
Identifier Type: -
Identifier Source: org_study_id
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