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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06679049
Status
Recruiting
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Conditions

  • Tibial Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
May 2026
Primary completion
Jul 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Main HospitalBirminghamAlabama35294
Mel Leonard, BS
[email protected]
2055328944

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Main Hospital· Birmingham, AL

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