Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
NCT ID: NCT06679049
Last Updated: 2025-05-13
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-04-30
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Micromotion Cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
micromotion intramedullary nail cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
Standard Cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw
standard intramedullary nail cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw
Interventions
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micromotion intramedullary nail cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
standard intramedullary nail cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw
Eligibility Criteria
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Inclusion Criteria
* Stable Tibial fracture recommended for surgical intervention
* Unstable fracture patterns e.g. those needing a secondary intervention - masquelet/cement spacer)
* Previously non-ambulatory patients
* Delayed presentation of fracture (\>4 weeks)
* Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability
* Patients with an achieve infection or wound at the surgical site
* Any previous ligament or fracture surgery on the index site
* Inflammatory rheumatic disease or other rheumatic disease-
* Immune compromised patients (hepatitis, HIV, etc.)
* Unwilling or unable to participate or follow study protocol
18 Years
85 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Joseph Johnson
Associate Professor
Principal Investigators
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Joseph Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham Main Hospital
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UAB
Identifier Type: OTHER
Identifier Source: secondary_id
300013319
Identifier Type: -
Identifier Source: org_study_id
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