Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing

May 11, 2026 updated by: Joseph Johnson, University of Alabama at Birmingham

Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham Main Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 - 85 years
  • Stable Tibial fracture recommended for surgical intervention

Exclusion Criteria:

  • Patients not meeting inclusion criteria
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Micromotion Cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
Procedure: micromotion intramedullary nail cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
Experimental: Standard Cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw
Procedure: standard intramedullary nail cohort
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in radiographic union
Time Frame: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively
bridging callus, minimum three cortices bridged
12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in complication rates
Time Frame: 1 year post-operatively
Patient reported outcomes scores
1 year post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Joseph Johnson, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300013319
  • UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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