Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Subjects Undergoing Tibial Fracture Repair
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Alabama at Birmingham Main Hospital
Birmingham, Alabama 35294
Contact:
Mel Leonard, BS
2055328944
mnleonard@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Joseph Johnson, MD
205-934-1041
jpjohnso@uab.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.