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NCT Number: NCT06679049

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

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.

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Key information

Conditions

Tibial Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham Main Hospital

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Mel Leonard, BS

CONTACT

[email protected]

2055328944

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

micromotion intramedullary nail cohort

Procedure

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

standard intramedullary nail cohort

Procedure

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

Primary outcomes

  1. The difference in radiographic union

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

    bridging callus, minimum three cortices bridged

Secondary outcomes

  1. difference in complication rates

    Time frame: 1 year post-operatively

    Patient reported outcomes scores

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Johnson, MD

CONTACT

[email protected]

205-934-1041

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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