RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-30

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06679049

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.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 18 - 85 years * Stable Tibial fracture recommended for surgical intervention	* 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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Study Contact

Joseph Johnson, MD

CONTACT

205-934-1041

jpjohnso@uab.edu

Principal Investigator

Joseph Johnson, MD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham Main Hospital

Birmingham, Alabama, 35294

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Joseph Johnson, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-04-30

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2025-04-30

Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

Tibial Fractures