Tibial FractureNCT06976801
Tibial IMN Vs. Tibial Micromotion IMN
A study testing Intramedullary tibial Nail and Intermedullary nail in people with Tibial Fracture, run by University of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- Intramedullary tibial Nail and Intermedullary nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Unstable tibial fracture recommended for surgical intervention
Who cannot join
- 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
- Patients with an active infection or wound at the surgical site
- Utilizing worker's compensation at the time of screening
Show all 11Show fewer
- Any previous ligament or fracture surgery on the index site
- Inflammatory rheumatic disease or other rheumatic disease
- Immune compromised patients (hepatitis, HIV, etc.)
- Non-English-speaking patients
- Unwilling or unable to participate or follow study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashley Mayo contact
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Brianna Fram, MD, 773-834-8953, bfram@uchicago.edu
Michael Koch, Bachelor's, 773-834-8953, mkoch@bsd.uchicago.edu
About this study
Official title: Prospective, Randomized-control Trial Comparing Standard Intramedullary Tibial Fixation With Micromotion Tibial Intramedullary Fixation
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.
Read more
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.
Read the detailed description
The advent of the intramedullary nail (IMN) has revolutionized the treatment of tibial shaft fractures due to its percutaneous route of insertion, frequent facilitation of immediate weightbearing, and high rate of union. Recent research has revealed that selection of an appropriate IMN diameter is vital for maintaining fracture reduction and preventing complications. Using a larger diameter nail increases construct stability, permits load-sharing, and may lead to higher rates of union. On the other hand, aggressive reaming to permit a larger nail diameter can result in iatrogenic fracture upon insertion or removal.
Modern tibial nail designs have remained largely unchanged in the last 20 years with small ergonomic and efficiency changes without large scale improvements in their biomechanical induction of bone healing at the fracture site. Traditionally they include distal locking screws as well as proximal locking screws that are either fixed or dynamic allowing for small but largely irrelevant amounts of motion. Our understanding of bone healing and indirect bone generation includes the concept of micromotion which induces the creation of fibrous followed by bony callus. This concept requires strain levels and adequate micromotion at fracture sites to be biomechanically advantageous. One new tibial nail device recently available in the US and FDA approved for tibial nail fixation hopes to improve the biomechanical and biology environment for tibial healing, the OrthoXel tibial nail system. Unfortunately, there is a paucity of strong clinical data to support it. Additionally, there have been no prospective, randomized studies investigating the used of this nail compared to standard tibial nail designs and no studies have evaluated it in high risk tibial non-union patients..
The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails compared to a micromotion tibial nail device to evaluate the rates of union and post-operative outcomes. In an evaluation of patient factors, fracture patterns and patient reported outcomes, the investigators will bring clarity to the question of indications for the micromotion tibial nail in standard and high risk patients. To characterize our patient population, the investigators will evaluate type of injury (closed, open, gunshot wound), fracture morphology (OTA classification), patient risk factors (age, isolated vs. poly-trauma, Comorbidities, smoking, and Vit D levels) and surgical outcomes (blood loss, surgical time, construct stability). In addition to objective radiographic, ultrasonographic and physical exam outcomes, the investigators will collect patient reported outcomes in the form of PROMIS CAT and VAS scores.
Given the existing limitations in the literature, there is no guidance on indications for use of micromotion tibial nail fixation (MMIMNF) compared to standard intramedullary nail fixation (IMNF). By taking an approach that will be prospective and randomized, while assessing all known risk factors, the investigators expect our results will guide surgical treatment decisions around the use of these devices and in which populations they may be most useful. .
The proposed trial will be a parallel-group, superiority trial with equal randomization enrolling 242 tibial nail patients. Patients will be categorized into 2 cohorts: IMNF fixation(cohort 1), and MicroMotion Intramedullary tibial Nail fixation (cohort 2). The primary outcome will be nonunion. Secondary outcomes will include: overall complications (as a composite result (Infection ((deep and superficial)), revision surgery rate, removal of metalwork, non-union, malunion, amputation and death). Patient-Reported Outcomes Measurement Information System Physical Function Computerized Adaptive Testing (PROMIS PT CAT) scores, range of motion (ROM), pain, radiographic outcomes, time to bridging callus based on mRUST (>11) on Xray, time to single leg stance, and degree of callus seen on ultrasound at 6 \& 12 weeks.
- Conditions
- Tibial Fracture
- Being tested
- Intramedullary tibial Nail, Intermedullary nail
- Keywords
- Unstable tibial fracture, intramedullary nail, micromotion tibial nail fixation
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary tibial NailDevice
Also called MicroMotion Intramedullary tibial Nail
Subjects will receive the micromotion MicroMotion Intramedullary tibial Nail
Intermedullary nailDevice
The non-micromotion intermedullary nail
| Study group | Role | What they receive |
|---|---|---|
| micromotion tibial intramedullary fixation | Experimental | Subject will receive micromotion tibial intramedullary fixation Receives: Device: Intramedullary tibial Nail |
| non-micromotion tibial nail fixation | Active comparator | Subject will receive non-micromotion tibial nail fixation Receives: Device: Intermedullary nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare post-operative union rates
Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices.
Measured: six months
Secondary outcomes (7)
Compare complication rates
Compare complication rates outcomes in patients treated with tibial nails
Measured: one year
Time to single leg stance
Time (in days) it takes for the subject stand on a single leg.
Measured: one year
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.
Measured: one year
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.
Measured: one year
Ultra sound callus
Checking if a callus has appeared
Measured: 6 weeks
Ultra sound callus
Checking if callus has appeared
Measured: 12 weeks
Visual analog pain scale score
Visual analog pain scale scores for the subject. Scored on a scale of 0 - 10. 0 no pain and 10 worst pain.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Jul 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The only intervention involved in this study is randomization between the two surgical devices. Subgroups will be determined using equal block randomization. Block randomization will be used for this study. Blocks will be set to groups of 4 with each block of 4 comprising 2 MMIMNF and 2 IMNF opaque envelopes in random order. The envelope will be opened in the OR prior to beginning the procedure. This ensures subjects are blinded to their initial treatment modality. Standard of care will be followed for all clinical decisions beyond the type of surgical procedure to be used.
- Masking
- None (open label)
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976801
- Sponsor's protocol ID
- IRB24-0601
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share individual participant data
Publications
Whittle AP, Wester W, Russell TA. Fatigue failure in small diameter tibial nails. Clin Orthop Relat Res. 1995 Jun;(315):119-28.
PubMed 7634660Hutson JJ, Zych GA, Cole JD, Johnson KD, Ostermann P, Milne EL, Latta L. Mechanical failures of intramedullary tibial nails applied without reaming. Clin Orthop Relat Res. 1995 Jun;(315):129-37.
PubMed 7634661Bonafede M, Espindle D, Bower AG. The direct and indirect costs of long bone fractures in a working age US population. J Med Econ. 2013;16(1):169-78. doi: 10.3111/13696998.2012.737391. Epub 2012 Oct 22.
PubMed 23035626Weber CD, Hildebrand F, Kobbe P, Lefering R, Sellei RM, Pape HC; TraumaRegister DGU. Epidemiology of open tibia fractures in a population-based database: update on current risk factors and clinical implications. Eur J Trauma Emerg Surg. 2019 Jun;45(3):445-453. doi: 10.1007/s00068-018-0916-9. Epub 2018 Feb 2.
PubMed 29396757Park S, Ahn J, Gee AO, Kuntz AF, Esterhai JL. Compartment syndrome in tibial fractures. J Orthop Trauma. 2009 Aug;23(7):514-8. doi: 10.1097/BOT.0b013e3181a2815a.
PubMed 19633461Zura R, Xiong Z, Einhorn T, Watson JT, Ostrum RF, Prayson MJ, Della Rocca GJ, Mehta S, McKinley T, Wang Z, Steen RG. Epidemiology of Fracture Nonunion in 18 Human Bones. JAMA Surg. 2016 Nov 16;151(11):e162775. doi: 10.1001/jamasurg.2016.2775. Epub 2016 Nov 16.
PubMed 27603155Sprague S, Bhandari M. An economic evaluation of early versus delayed operative treatment in patients with closed tibial shaft fractures. Arch Orthop Trauma Surg. 2002 Jul;122(6):315-23. doi: 10.1007/s00402-001-0358-3. Epub 2001 Dec 12.
PubMed 12136294Anandasivam NS, Russo GS, Swallow MS, Basques BA, Samuel AM, Ondeck NT, Chung SH, Fischer JM, Bohl DD, Grauer JN. Tibial shaft fracture: A large-scale study defining the injured population and associated injuries. J Clin Orthop Trauma. 2017 Jul-Sep;8(3):225-231. doi: 10.1016/j.jcot.2017.07.012. Epub 2017 Jul 24.
PubMed 28951639Rosa N, Marta M, Vaz M, Tavares SMO, Simoes R, Magalhaes FD, Marques AT. Intramedullary nailing biomechanics: Evolution and challenges. Proc Inst Mech Eng H. 2019 Mar;233(3):295-308. doi: 10.1177/0954411919827044.
PubMed 30887900Eveleigh RJ. A review of biomechanical studies of intramedullary nails. Med Eng Phys. 1995 Jul;17(5):323-31. doi: 10.1016/1350-4533(95)97311-c.
PubMed 7670691Donegan DJ, Akinleye S, Taylor RM, Baldwin K, Mehta S. Intramedullary Nailing of Tibial Shaft Fractures: Size Matters. J Orthop Trauma. 2016 Jul;30(7):377-80. doi: 10.1097/BOT.0000000000000555.
PubMed 26825491
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized-control Trial Comparing Standard Intramedullary Tibial Fixation With Micromotion Tibial Intramedullary Fixation
- ClinicalTrials.gov ID
- NCT06976801
- Acronym / sponsor ID
- IRB24-0601
- Conditions
- Tibial Fracture
- Keywords
- Unstable tibial fracture, intramedullary nail, micromotion tibial nail fixation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The advent of the intramedullary nail (IMN) has revolutionized the treatment of tibial shaft fractures due to its percutaneous route of insertion, frequent facilitation of immediate weightbearing, and high rate of union. Recent research has revealed that selection of an appropriate IMN diameter is vital for maintaining fracture reduction and preventing complications. Using a larger diameter nail increases construct stability, permits load-sharing, and may lead to higher rates of union. On the other hand, aggressive reaming to permit a larger nail diameter can result in iatrogenic fracture upon insertion or removal.
Modern tibial nail designs have remained largely unchanged in the last 20 years with small ergonomic and efficiency changes without large scale improvements in their biomechanical induction of bone healing at the fracture site. Traditionally they include distal locking screws as well as proximal locking screws that are either fixed or dynamic allowing for small but largely irrelevant amounts of motion. Our understanding of bone healing and indirect bone generation includes the concept of micromotion which induces the creation of fibrous followed by bony callus. This concept requires strain levels and adequate micromotion at fracture sites to be biomechanically advantageous. One new tibial nail device recently available in the US and FDA approved for tibial nail fixation hopes to improve the biomechanical and biology environment for tibial healing, the OrthoXel tibial nail system. Unfortunately, there is a paucity of strong clinical data to support it. Additionally, there have been no prospective, randomized studies investigating the used of this nail compared to standard tibial nail designs and no studies have evaluated it in high risk tibial non-union patients..
The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails compared to a micromotion tibial nail device to evaluate the rates of union and post-operative outcomes. In an evaluation of patient factors, fracture patterns and patient reported outcomes, the investigators will bring clarity to the question of indications for the micromotion tibial nail in standard and high risk patients. To characterize our patient population, the investigators will evaluate type of injury (closed, open, gunshot wound), fracture morphology (OTA classification), patient risk factors (age, isolated vs. poly-trauma, Comorbidities, smoking, and Vit D levels) and surgical outcomes (blood loss, surgical time, construct stability). In addition to objective radiographic, ultrasonographic and physical exam outcomes, the investigators will collect patient reported outcomes in the form of PROMIS CAT and VAS scores.
Given the existing limitations in the literature, there is no guidance on indications for use of micromotion tibial nail fixation (MMIMNF) compared to standard intramedullary nail fixation (IMNF). By taking an approach that will be prospective and randomized, while assessing all known risk factors, the investigators expect our results will guide surgical treatment decisions around the use of these devices and in which populations they may be most useful. .
The proposed trial will be a parallel-group, superiority trial with equal randomization enrolling 242 tibial nail patients. Patients will be categorized into 2 cohorts: IMNF fixation(cohort 1), and MicroMotion Intramedullary tibial Nail fixation (cohort 2). The primary outcome will be nonunion. Secondary outcomes will include: overall complications (as a composite result (Infection ((deep and superficial)), revision surgery rate, removal of metalwork, non-union, malunion, amputation and death). Patient-Reported Outcomes Measurement Information System Physical Function Computerized Adaptive Testing (PROMIS PT CAT) scores, range of motion (ROM), pain, radiographic outcomes, time to bridging callus based on mRUST (>11) on Xray, time to single leg stance, and degree of callus seen on ultrasound at 6 \& 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The only intervention involved in this study is randomization between the two surgical devices. Subgroups will be determined using equal block randomization. Block randomization will be used for this study. Blocks will be set to groups of 4 with each block of 4 comprising 2 MMIMNF and 2 IMNF opaque envelopes in random order. The envelope will be opened in the OR prior to beginning the procedure. This ensures subjects are blinded to their initial treatment modality. Standard of care will be followed for all clinical decisions beyond the type of surgical procedure to be used.
| Arm | Type | Receives |
|---|---|---|
| micromotion tibial intramedullary fixation | Experimental | Device: Intramedullary tibial NailSubject will receive micromotion tibial intramedullary fixation |
| non-micromotion tibial nail fixation | Active comparator | Device: Intermedullary nailSubject will receive non-micromotion tibial nail fixation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Unstable tibial fracture recommended for surgical intervention
Key exclusion criteria (11 listed)
- 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
- Patients with an active infection or wound at the surgical site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramedullary tibial NailAlso: MicroMotion Intramedullary tibial NailSubjects will receive the micromotion MicroMotion Intramedullary tibial Nail | Device | micromotion tibial intramedullary fixation |
| Intermedullary nailThe non-micromotion intermedullary nail | Device | non-micromotion tibial nail fixation |
Primary outcome
Compare post-operative union rates
Time frame: six months
Compare post-operative union rates in tibial shaft patients treated with 2 types of intramedullary rod fixation devices.
7 secondary outcomes
Compare complication rates
Time frame: one year
Time to single leg stance
Time frame: one year
Any difference in patient reported outcomes scores physical function
Time frame: one year
Any difference in patient reported outcomes scores pain interference
Time frame: one year
Ultra sound callus
Time frame: 6 weeks
Ultra sound callus
Time frame: 12 weeks
Visual analog pain scale score
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 7634660Whittle AP, Wester W, Russell TA. Fatigue failure in small diameter tibial nails. Clin Orthop Relat Res. 1995 Jun;(315):119-28.
- Background: PubMed 7634661Hutson JJ, Zych GA, Cole JD, Johnson KD, Ostermann P, Milne EL, Latta L. Mechanical failures of intramedullary tibial nails applied without reaming. Clin Orthop Relat Res. 1995 Jun;(315):129-37.
- Background: PubMed 23035626Bonafede M, Espindle D, Bower AG. The direct and indirect costs of long bone fractures in a working age US population. J Med Econ. 2013;16(1):169-78. doi: 10.3111/13696998.2012.737391. Epub 2012 Oct 22.
- Background: PubMed 29396757Weber CD, Hildebrand F, Kobbe P, Lefering R, Sellei RM, Pape HC; TraumaRegister DGU. Epidemiology of open tibia fractures in a population-based database: update on current risk factors and clinical implications. Eur J Trauma Emerg Surg. 2019 Jun;45(3):445-453. doi: 10.1007/s00068-018-0916-9. Epub 2018 Feb 2.
- Background: PubMed 19633461Park S, Ahn J, Gee AO, Kuntz AF, Esterhai JL. Compartment syndrome in tibial fractures. J Orthop Trauma. 2009 Aug;23(7):514-8. doi: 10.1097/BOT.0b013e3181a2815a.
- Background: PubMed 27603155Zura R, Xiong Z, Einhorn T, Watson JT, Ostrum RF, Prayson MJ, Della Rocca GJ, Mehta S, McKinley T, Wang Z, Steen RG. Epidemiology of Fracture Nonunion in 18 Human Bones. JAMA Surg. 2016 Nov 16;151(11):e162775. doi: 10.1001/jamasurg.2016.2775. Epub 2016 Nov 16.
- Background: PubMed 12136294Sprague S, Bhandari M. An economic evaluation of early versus delayed operative treatment in patients with closed tibial shaft fractures. Arch Orthop Trauma Surg. 2002 Jul;122(6):315-23. doi: 10.1007/s00402-001-0358-3. Epub 2001 Dec 12.
- Background: PubMed 28951639Anandasivam NS, Russo GS, Swallow MS, Basques BA, Samuel AM, Ondeck NT, Chung SH, Fischer JM, Bohl DD, Grauer JN. Tibial shaft fracture: A large-scale study defining the injured population and associated injuries. J Clin Orthop Trauma. 2017 Jul-Sep;8(3):225-231. doi: 10.1016/j.jcot.2017.07.012. Epub 2017 Jul 24.
- Background: PubMed 30887900Rosa N, Marta M, Vaz M, Tavares SMO, Simoes R, Magalhaes FD, Marques AT. Intramedullary nailing biomechanics: Evolution and challenges. Proc Inst Mech Eng H. 2019 Mar;233(3):295-308. doi: 10.1177/0954411919827044.
- Background: PubMed 7670691Eveleigh RJ. A review of biomechanical studies of intramedullary nails. Med Eng Phys. 1995 Jul;17(5):323-31. doi: 10.1016/1350-4533(95)97311-c.
- Background: PubMed 26825491Donegan DJ, Akinleye S, Taylor RM, Baldwin K, Mehta S. Intramedullary Nailing of Tibial Shaft Fractures: Size Matters. J Orthop Trauma. 2016 Jul;30(7):377-80. doi: 10.1097/BOT.0000000000000555.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Mayo contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary tibial Nail and Intermedullary nail in people with Tibial Fracture, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brianna Fram, MD (773-834-3531, bfram@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare post-operative union rates (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06976801, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.