Tibial FracturesNCT06679049
Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
A study testing micromotion intramedullary nail cohort and standard intramedullary nail cohort in people with Tibial Fractures, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- micromotion intramedullary nail cohort and standard intramedullary nail cohort
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to 31 Jan 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 85 years
- Stable Tibial fracture recommended for surgical intervention
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham Main Hospital
Birmingham, Alabama, 35294
Mel Leonard, BS, 2055328944, mnleonard@uabmc.edu
About this study
Official title: Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
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.
- Conditions
- Tibial Fractures
- Being tested
- micromotion intramedullary nail cohort, standard intramedullary nail cohort
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micromotion intramedullary nail cohortProcedure or surgery
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
standard intramedullary nail cohortProcedure or surgery
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw
| Study group | Role | What they receive |
|---|---|---|
| Micromotion Cohort | Experimental | use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw Receives: Procedure: micromotion intramedullary nail cohort |
| Standard Cohort | Experimental | use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw Receives: Procedure: standard intramedullary nail cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in radiographic union
bridging callus, minimum three cortices bridged
Measured: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively
Secondary outcomes (1)
difference in complication rates
Patient reported outcomes scores
Measured: 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start30 Apr 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Single group
- Model description
- Subjects Undergoing Tibial Fracture Repair
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Johnson, University of Alabama at Birmingham
- Investigators
- Joseph Johnson, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679049
- Sponsor's protocol ID
- IRB-300013319
- Other IDs
- UAB
- Status last verified
- Jul 2026
- First submitted
- 6 Nov 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
- ClinicalTrials.gov ID
- NCT06679049
- Acronym / sponsor ID
- IRB-300013319
- Conditions
- Tibial Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 Nov 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects Undergoing Tibial Fracture Repair
| Arm | Type | Receives |
|---|---|---|
| Micromotion Cohort | Experimental | Procedure: micromotion intramedullary nail cohortuse of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw |
| Standard Cohort | Experimental | Procedure: standard intramedullary nail cohortuse of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 - 85 years
- Stable Tibial fracture recommended for surgical intervention
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| micromotion intramedullary nail cohortuse of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw | Procedure or surgery | Micromotion Cohort |
| standard intramedullary nail cohortuse of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw | Procedure or surgery | Standard Cohort |
Primary outcome
The difference in radiographic union
Time frame: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively
bridging callus, minimum three cortices bridged
1 secondary outcome
difference in complication rates
Time frame: 1 year post-operatively
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Joseph Johnson, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micromotion intramedullary nail cohort and standard intramedullary nail cohort in people with Tibial Fractures, run by University of Alabama at Birmingham 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 10 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 14 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 Joseph Johnson, MD (205-934-1041, jpjohnso@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in radiographic union (time frame: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.