Tibial IMN Vs. Tibial Micromotion IMN

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

Our null hypothesis is that micromotion tibial intramedullary fixation (IMFN) does not impact union or complication rates when compared to standard of care treatment with non-micromotion tibial nail fixation. There are no current or past randomized controlled trials comparing these fixation techniques to one another. There is good data supporting both the use of intramedullary fixation for tibial fractures alone, and in high-risk patient populations (open fractures, GSW tibial fractures). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.

With much of the limited existing literature on tibial nails being in very defined populations, without a strong comparison group there is no clear guidance on when the use of a micromotion device is indicated. Our approach to randomize our patients will reduce the bias that exists in the current literature and provide a robust spectrum of injuries to sub analyze and compare.

Objectives Primary Objective Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices.

Secondary Objective(s) Compare complication rates, patient reported outcomes, range of motion, pain and radiographic/sonographic outcomes in patients treated with tibial nails.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older

Unstable tibial fracture recommended for surgical intervention

Disqualifiers

Patients not meeting inclusion criteria (Stable fracture patterns)

Previously non-ambulatory patients

Delayed presentation of fracture (>4 weeks)

Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intramedullary tibial Nail

    Device

    Subjects will receive the micromotion MicroMotion Intramedullary tibial Nail

  • Intermedullary nail

    Device

    The non-micromotion intermedullary nail

Treatment groups

372 Participants
are divided into 2 treatment groups
Group A: micromotion tibial intramedullary fixationExperimental treatment 1 intervention
Group B: non-micromotion tibial nail fixationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Compare post-operative union rates

Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices.

Time frame
six months

Secondary outcomes

1

Compare complication rates

Compare complication rates outcomes in patients treated with tibial nails

Time frame
one year
2

Time to single leg stance

Time (in days) it takes for the subject stand on a single leg.

Time frame
one year
3

Any difference in patient reported outcomes scores physical function

Patient Reported outcome scores physical function scores are reported on a T-score scale that ranges from 20-80, with higher scores indicating greater physical function.

Time frame
one year
4

Any difference in patient reported outcomes scores pain interference

Patient Reported outcome scores pain interference scores are reported on a T-score scale that ranges from 6-30, with higher scores indicating greater physical function.

Time frame
one year

Other outcomes

1

Smoking Status

Comparing the smoking status (yes/no and pack years) and return to OR timelines

Time frame
one year
2

Visual analog pain scale score

Visual analog pain scale score? 0 (no pain) - 10 (worst pain)

Time frame
one year
3

Fixation failure rate

Comparing the fixation failure rates between the two groups and return to OR timelines

Time frame
one year
4

Radiographic Mal-union

Comparing Radiographic Mal-union rates between groups

Time frame
one year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.