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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06679049

Enrollment

100

Registered

2024-11-07

Start date

2025-04-30

Completion date

2027-01-31

Last updated

2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Fractures

Brief summary

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.

Interventions

PROCEDUREmicromotion intramedullary nail cohort

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

PROCEDUREstandard intramedullary nail cohort

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Subjects Undergoing Tibial Fracture Repair

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The difference in radiographic union	12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively	bridging callus, minimum three cortices bridged

Secondary

Measure	Time frame	Description
difference in complication rates	1 year post-operatively	Patient reported outcomes scores

Countries

United States

Contacts

CONTACTJoseph Johnson, MD

jpjohnso@uab.edu205-934-1041

PRINCIPAL_INVESTIGATORJoseph Johnson, MD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026