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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Intramedullary tibial Nail
DeviceSubjects will receive the micromotion MicroMotion Intramedullary tibial Nail
Intermedullary nail
DeviceThe non-micromotion intermedullary nail
Treatment groups
Trial outcomes
Primary outcomes
Compare post-operative union rates
Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices.
Secondary outcomes
Compare complication rates
Compare complication rates outcomes in patients treated with tibial nails
Time to single leg stance
Time (in days) it takes for the subject stand on a single leg.
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.
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.
Other outcomes
Smoking Status
Comparing the smoking status (yes/no and pack years) and return to OR timelines
Visual analog pain scale score
Visual analog pain scale score? 0 (no pain) - 10 (worst pain)
Fixation failure rate
Comparing the fixation failure rates between the two groups and return to OR timelines
Radiographic Mal-union
Comparing Radiographic Mal-union rates between groups
Sponsors and contacts
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