Recruiting

Intramedullary Tibial Nail vs. Micromotion Tibial Nail

Sponsor:

University of Alabama at Birmingham

Code:

NCT06679049

Conditions

Tibial Fractures

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

micromotion intramedullary nail cohort

standard intramedullary nail cohort

Study Details

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.

Conditions

Tibial Fractures

Study ID

NCT06679049

Start date

Apr 30, 2025

Status verified date

Jul, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Micromotion Cohort

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

experimental: Standard Cohort

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

Interventions

micromotion intramedullary nail cohort

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

standard intramedullary nail cohort

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

Primary outcome measure

  • The difference in radiographic union [ Time Frame: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively ]

Central Contacts and Locations

Central contacts

Joseph Johnson, MD

205-934-1041jpjohnso@uab.edu

Locations

University of Alabama at Birmingham Main Hospital

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Mel Leonard, BS

2055328944mnleonard@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-07-14.