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

NCT06679049 | Recruiting

• 2 other identifiers: 300013319UAB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tibial Fractures

Outcome Measures

Primary Outcomes (1)

• The difference in radiographic union

  bridging callus, minimum three cortices bridged

  12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively

Secondary Outcomes (1)

• difference in complication rates

  1 year post-operatively

Study Arms (2)

Micromotion Cohort

EXPERIMENTAL

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

Standard Cohort

EXPERIMENTAL

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

Procedure: standard intramedullary nail cohort

Interventions

micromotion intramedullary nail cohort PROCEDURE

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

Micromotion Cohort

standard intramedullary nail cohort PROCEDURE

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

Standard Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Main Hospital

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Joseph Johnson, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Johnson, MD

CONTACT

205-934-1041; jpjohnso@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects Undergoing Tibial Fracture Repair

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: April 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)