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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-12-01

Brief Summary

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The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.

Detailed Description

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Conditions

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Tibial Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Subjects Undergoing Tibial Fracture Repair
Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

micromotion intramedullary nail cohort

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

standard intramedullary nail cohort

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

standard intramedullary nail cohort

use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 - 85 years
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Joseph Johnson

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joseph Johnson, MD

Role: CONTACT

205-934-1041

Facility Contacts

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Mel Leonard, BS

Role: primary

2055328944

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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