Tibial IMN Vs. Tibial Micromotion IMN

NCT06976801 | Recruiting FDA Device

• 1 other identifier: IRB24-0601
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tibial Fracture

Keywords

Unstable tibial fracture; intramedullary nail; micromotion tibial nail fixation

Outcome Measures

Primary Outcomes (1)

• Compare post-operative union rates

  Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices.

  six months

Secondary Outcomes (7)

• Compare complication rates

  one year

• Time to single leg stance

  one year

• Any difference in patient reported outcomes scores physical function

  one year

• Any difference in patient reported outcomes scores pain interference

  one year

• Ultra sound callus

  6 weeks

Other Outcomes (13)

• Smoking Status

  one year

• Visual analog pain scale score

  one year

• Fixation failure rate

  one year

Study Arms (2)

micromotion tibial intramedullary fixation

EXPERIMENTAL

Subject will receive micromotion tibial intramedullary fixation

Device: Intramedullary tibial Nail

non-micromotion tibial nail fixation

ACTIVE COMPARATOR

Subject will receive non-micromotion tibial nail fixation

Device: Intermedullary nail

Interventions

Intramedullary tibial Nail DEVICE

Subjects will receive the micromotion MicroMotion Intramedullary tibial Nail

Also known as: MicroMotion Intramedullary tibial Nail

micromotion tibial intramedullary fixation

Intermedullary nail DEVICE

The non-micromotion intermedullary nail

non-micromotion tibial nail fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Unstable tibial fracture recommended for surgical intervention

You may not qualify if:

• 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 active infection or wound at the surgical site
• Utilizing worker's compensation at the time of screening
• Any previous ligament or fracture surgery on the index site
• Inflammatory rheumatic disease or other rheumatic disease
• Immune compromised patients (hepatitis, HIV, etc.)
• Non-English-speaking patients
• Unwilling or unable to participate or follow study protocol

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (11)

• Whittle AP, Wester W, Russell TA. Fatigue failure in small diameter tibial nails. Clin Orthop Relat Res. 1995 Jun;(315):119-28.

  PMID: 7634660 BACKGROUND

• Hutson JJ, Zych GA, Cole JD, Johnson KD, Ostermann P, Milne EL, Latta L. Mechanical failures of intramedullary tibial nails applied without reaming. Clin Orthop Relat Res. 1995 Jun;(315):129-37.

  PMID: 7634661 BACKGROUND

• Bonafede M, Espindle D, Bower AG. The direct and indirect costs of long bone fractures in a working age US population. J Med Econ. 2013;16(1):169-78. doi: 10.3111/13696998.2012.737391. Epub 2012 Oct 22.

  PMID: 23035626 BACKGROUND

• Weber CD, Hildebrand F, Kobbe P, Lefering R, Sellei RM, Pape HC; TraumaRegister DGU. Epidemiology of open tibia fractures in a population-based database: update on current risk factors and clinical implications. Eur J Trauma Emerg Surg. 2019 Jun;45(3):445-453. doi: 10.1007/s00068-018-0916-9. Epub 2018 Feb 2.

  PMID: 29396757 BACKGROUND

• Park S, Ahn J, Gee AO, Kuntz AF, Esterhai JL. Compartment syndrome in tibial fractures. J Orthop Trauma. 2009 Aug;23(7):514-8. doi: 10.1097/BOT.0b013e3181a2815a.

  PMID: 19633461 BACKGROUND

• Zura R, Xiong Z, Einhorn T, Watson JT, Ostrum RF, Prayson MJ, Della Rocca GJ, Mehta S, McKinley T, Wang Z, Steen RG. Epidemiology of Fracture Nonunion in 18 Human Bones. JAMA Surg. 2016 Nov 16;151(11):e162775. doi: 10.1001/jamasurg.2016.2775. Epub 2016 Nov 16.

  PMID: 27603155 BACKGROUND

• Sprague S, Bhandari M. An economic evaluation of early versus delayed operative treatment in patients with closed tibial shaft fractures. Arch Orthop Trauma Surg. 2002 Jul;122(6):315-23. doi: 10.1007/s00402-001-0358-3. Epub 2001 Dec 12.

  PMID: 12136294 BACKGROUND

• Anandasivam NS, Russo GS, Swallow MS, Basques BA, Samuel AM, Ondeck NT, Chung SH, Fischer JM, Bohl DD, Grauer JN. Tibial shaft fracture: A large-scale study defining the injured population and associated injuries. J Clin Orthop Trauma. 2017 Jul-Sep;8(3):225-231. doi: 10.1016/j.jcot.2017.07.012. Epub 2017 Jul 24.

  PMID: 28951639 BACKGROUND

• Rosa N, Marta M, Vaz M, Tavares SMO, Simoes R, Magalhaes FD, Marques AT. Intramedullary nailing biomechanics: Evolution and challenges. Proc Inst Mech Eng H. 2019 Mar;233(3):295-308. doi: 10.1177/0954411919827044.

  PMID: 30887900 BACKGROUND

• Eveleigh RJ. A review of biomechanical studies of intramedullary nails. Med Eng Phys. 1995 Jul;17(5):323-31. doi: 10.1016/1350-4533(95)97311-c.

  PMID: 7670691 BACKGROUND

• Donegan DJ, Akinleye S, Taylor RM, Baldwin K, Mehta S. Intramedullary Nailing of Tibial Shaft Fractures: Size Matters. J Orthop Trauma. 2016 Jul;30(7):377-80. doi: 10.1097/BOT.0000000000000555.

  PMID: 26825491 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Anthony Christiano, MD

CONTACT

773-834-3531; anthony.christiano@bsd.uchicago.edu

Douglas Zhang, BS

CONTACT

douglas.zhang@uchicagomedicine.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The only intervention involved in this study is randomization between the two surgical devices. Subgroups will be determined using equal block randomization. Block randomization will be used for this study. Blocks will be set to groups of 4 with each block of 4 comprising 2 MMIMNF and 2 IMNF opaque envelopes in random order. The envelope will be opened in the OR prior to beginning the procedure. This ensures subjects are blinded to their initial treatment modality. Standard of care will be followed for all clinical decisions beyond the type of surgical procedure to be used.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: May 16, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)