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Recruiting NCT06679049

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

No phase Interventional Tibial Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: micromotion intramedullary nail cohort, standard intramedullary nail cohort.
Who it may be relevant to
Registry conditions: Tibial Fractures. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure micromotion intramedullary nail cohort
    use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
  • Procedure 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 measures

  • The difference in radiographic union [Time frame: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively]
Secondary outcome measures (1)
  • difference in complication rates [Time frame: 1 year post-operatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Alabama at Birmingham Main Hospital — Birmingham

Identifiers

NCT: NCT06679049 · IRB-300013319 · UAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗