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

University of Alabama at Birmingham100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Tibial Fractures

Interventions

micromotion intramedullary nail cohortPROCEDURE

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

standard intramedullary nail cohortPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alabama at Birmingham Main Hospital

Birmingham, Alabama, United States

RECRUITING

Outcomes

Primary Outcomes

The difference in radiographic union

bridging callus, minimum three cortices bridged

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

Secondary Outcomes

difference in complication rates

Patient reported outcomes scores

Time frame: 1 year post-operatively

Central Contacts

Joseph Johnson, MD

CONTACT

205-934-1041 jpjohnso@uab.edu

Data from ClinicalTrials.gov

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