MedTrace Logo

Assessment of Fixation Strategies for Severe Open Tibia Fractures

NCT01494519 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2019-02-07

No results posted yet for this study

Summary

The purpose of this study is to compare the use of modern ring external fixation versus internal fixation for fracture stabilization of severe open tibia fractures.

Conditions

  • Severe Open Fractures of the Tibia (Shin) Bone

Interventions

PROCEDURE

Surgery with an external ring fixator

Modern ring external fixator is defined as any fixator that has at least 1 ring proximal and 1 ring distal to the fracture site. The rings may be connected to the tibia using any combination of external fixation pins or wires at the surgeon's discretion. There must be at least two pins or wires connected to each ring, and typically there will be at least three pins or wires. Any FDA approved ring fixator meeting this definition from any manufacturer is allowed.

PROCEDURE

Definitive fixation with a locked IM nail or plate

Eligible patients with tibial diaphyseal fractures will typically receive a standard locked IM Nail. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with either a reamed or unreamed technique. Methaphyseal fractures, especially those with fracture lines extending into the joint may be more commonly treated with plate fixation. The plate may be applied in an open or percutaneous fashion. Any combination of locked and/or non-locked screws may be used.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • Lisa Reider, MHS, PhD · Major Extremity Trauma Research Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2017-09-30
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01494519 on ClinicalTrials.gov