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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Tibial Fractures

Treatments: Procedure: standard intramedullary nail cohort; Procedure: micromotion intramedullary nail cohort

Study type: Interventional

Funder types: Other

Identifiers

NCT06679049

300013319

UAB (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Micromotion Cohort

Experimental group

Description:

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

Treatment:

Procedure: micromotion intramedullary nail cohort

Standard Cohort

Experimental group

Description:

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

Treatment:

Procedure: standard intramedullary nail cohort