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RECRUITING NA

Intramedullary Bone Grafting for Open Tibial Shaft Fractures

NCT03891888 · View on ClinicalTrials.gov ↗

Study Summary

This study will examine if there is a difference between the time to full union between the control group and the study group. Each group will be composed of patients who have an open fracture in the mid tibia. Both groups will undergo primary fixation via reamed intramedulary nailing (IMN), a common treatment for tibia shaft fractures in adults. The study group will have a bone graft applied to the open cortex of the fracture. The bone graft will be composed of the intramedullary reamings, which are a byproduct produced when the intramedullary canal is reamed in preparation for insertion of the IMN.

Interventions

  • PROCEDURE Intramedullary Bone Graft

Study Locations (2)

Kentucky

  • University of Louisville Hospital — Louisville
  • University of Louisville Hospital — Louisville

Trial Details

FieldValue
Enrollment Target 130 participants
Start Date 2020-03-26
Est. Completion 2025-02
Phase NA

Sponsor

University of Louisville

260 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03891888

The ClinicalTrials.gov registry entry for NCT03891888 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 260 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Tibial Fractures appearing as the primary indexed condition, and to 1 intervention — of which Intramedullary Bone Graft is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03891888 reports 2 study locations spanning 1 distinct geographic area — top geographies include Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03891888 about?

NCT03891888 is a clinical study titled "Intramedullary Bone Grafting for Open Tibial Shaft Fractures". This study will examine if there is a difference between the time to full union between the control group and the study group. Each group will be composed of patients who have an open fracture in the mid tibia. Both groups will undergo primary fixation via reamed intramedulary nailing (IMN), a commo...

What is the current status of trial NCT03891888?

This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2020-03-26. Estimated completion is 2025-02.

What conditions does trial NCT03891888 study?

This clinical trial studies the following conditions: Tibial Fractures, Nonunion of Fracture, Delayed Union of Fracture. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03891888?

The interventions under investigation include: Intramedullary Bone Graft (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03891888?

This trial is sponsored by University of Louisville, which has 260 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03891888 being conducted?

This trial has 2 study locations across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial