Tibial IMN Vs. Tibial Micromotion IMN

Conditions

• Tibial Fracture

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intramedullary tibial Nail — DEVICE
  Subjects will receive the micromotion MicroMotion Intramedullary tibial Nail
• Intermedullary nail — DEVICE
  The non-micromotion intermedullary nail

Study Details

Our null hypothesis is that micromotion tibial intramedullary fixation (IMFN) does not impact union or complication rates when compared to standard of care treatment with non-micromotion tibial nail fixation. There are no current or past randomized controlled trials comparing these fixation techniques to one another. There is good data supporting both the use of intramedullary fixation for tibial fractures alone, and in high-risk patient populations (open fractures, GSW tibial fractures). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications. With much of the limited existing literature on tibial nails being in very defined populations, without a strong comparison group there is no clear guidance on when the use of a micromotion device is indicated. Our approach to randomize our patients will reduce the bias that exists in the current literature and provide a robust spectrum of injuries to sub analyze and compare. Objectives Primary Objective Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices. Secondary Objective(s) Compare complication rates, patient reported outcomes, range of motion, pain and radiographic/sonographic outcomes in patients treated with tibial nails.

Key Dates

Start date

Jul 1, 2025

Status verified

May 2025

Primary completion

Dec 31, 2029

Completion

Dec 31, 2030

Study Design

Enrollment

372 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: micromotion tibial intramedullary fixation
  Subject will receive micromotion tibial intramedullary fixation
• Active Comparator: non-micromotion tibial nail fixation
  Subject will receive non-micromotion tibial nail fixation

Primary Outcome Measure

Compare post-operative union rates [ Time Frame: six months ]

Central Contacts

• Anthony Christiano, MD
  773-834-3531
  [email protected]
• Douglas Zhang, BS
  [email protected]

Locations (1)

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