Tibial Shaft FractureNCT05521958
Gene Expression in Lower Extremity Acute Traumatic Compartment Syndrome
A study testing Acute injury without compartment syndrome, Acute injury with compartment syndrome and Exertional compartment syndrome in people with Tibial Shaft Fracture and Tibial Plateau Fracture, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to evaluate both genotypic differences and differences in local gene expression in individuals who develop acute traumatic compartment syndrome relative to control patients with at-risk lower extremity fractures who do not develop compartment syndrome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tibial Shaft Fracture, Tibial Plateau Fracture
- What is being tested?
- Acute injury without compartment syndrome, Acute injury with compartment syndrome and Exertional compartment syndrome
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2022to Jun 2028
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18+ years of age. English speaking.
- Patients with the clinical diagnosis of lower leg acute compartment syndrome secondary to tibial shaft or tibial plateau fracture.
- Patients without clinical compartment syndrome undergoing operative intervention within 48 hours of injury for tibial shaft or tibial plateau fractures.
- Patients with the clinical diagnosis of exertional compartment syndrome with planned surgical intervention.
Who cannot join
- Non-english speaking participants
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
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84112
About this study
Official title: Genetics and Local Gene Expression in Lower Extremity Acute Traumatic Compartment Syndrome
The purpose of this study is to evaluate both genotypic differences and differences in local gene expression in individuals who develop acute traumatic compartment syndrome relative to control patients with at-risk lower extremity fractures who do not develop compartment syndrome.
Read the detailed description
Acute compartment syndrome is associated with infection, contractures, fracture non-union, and chronic pain syndromes. The most common cause of acute compartment syndrome is fracture. Individuals with compartment syndrome associated with a lower extremity fracture have demonstrated worse patient reported outcome scores compared to individuals who suffer lower extremity fractures alone.
The pathophysiology of compartment syndrome has been traditionally described as loss of tissue perfusion and subsequent cellular anoxia related to supra-physiologic pressure within a closed myofascial space. Both animal and clinical studies have suggested that compartment syndrome develops when the intra-compartmental pressure approaches systemic diastolic blood pressure. However, other studies have demonstrated that high absolute compartment pressures and/or narrowed delta pressures have poor sensitivity for predicting compartment syndrome, suggesting that the pathophysiology of compartment syndrome is likely more complex than the currently accepted understanding of the disease process.
Animal models suggest that fracture promotes inflammation and exacerbates microvascular dysfunction, which may act synergistically with elevated intra-compartmental pressures to create clinical compartment syndrome. It is known that fracture causes microvascular damage and inflammation in surrounding muscle tissue. Several models have demonstrated that the microvascular environment in compartment syndrome is characterized by tenuous, intermittent blood supply to the musculature, which displays asymmetric microvascular dysfunction in response to elevated compartment pressures. Similarly, recent animal research has demonstrated that elevated intra-compartmental pressure is associated with a pro-inflammatory state, which directly contributes to skeletal muscle injury and may exacerbate microvascular injury.
It is unknown whether individual genomic and/or transcriptomic variability is clinically relevant with respect to response to fracture or the development of compartment syndrome. However, there is evidence from the vascular surgery literature in both animal and human models that individual variability in gene expression meaningfully affects skeletal muscle response to acute ischemia. The investigators hypothesize that there may be an individual pre-disposition to developing clinical compartment syndrome in the setting of at-risk fractures which manifests itself in the cellular response to inflammation and low grade ischemia. The overarching goal of this study is to characterize cellular level dysfunction in human compartment syndrome and to determine whether there are unique gene expression profiles associated with the development of clinical compartment syndrome. Specific aim 1 of this study is to compare genetic and transcriptomic differences individuals with high-risk tibia fractures who do not develop compartment syndrome and individuals with high-risk tibia fractures who do develop clinical compartment syndrome. Specific aim 2 of this study is to to compare genetic differences between acute compartment syndrome patients and chronic exertional compartment syndrome patients.
- Conditions
- Tibial Shaft Fracture, Tibial Plateau Fracture
- Being tested
- Acute injury without compartment syndrome, Acute injury with compartment syndrome, Exertional compartment syndrome
- Keywords
- tibial shaft or tibial plateau fracture, acute compartment syndrome, without acute compartment syndrome, exertional compartment syndrome, gene expression, myostatin
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute injury without compartment syndromeProcedure or surgery
Acute tibial shaft or tibial plateau fractures who do not have clinical compartment syndrome.
Muscle punch biopsy of the anterior compartment will be taken.
Acute injury with compartment syndromeProcedure or surgery
Acute tibial shaft or tibial plateau fractures who have clinical compartment syndrome.
Muscle punch biopsy of the anterior compartment will be taken.
Exertional compartment syndromeProcedure or surgery
For patients with exertional compartment syndrome, a muscle biopsy will be obtained from affected extremity.
| Study group | Role | What they receive |
|---|---|---|
| Acute tibial shaft or tibial plateau fractures without compartment syndrome | Other | Patients with acute lower leg fractures who do not have clinical compartment syndrome. Receives: Procedure: Acute injury without compartment syndrome |
| Acute tibial shaft or tibial plateau fractures with compartment syndrome. | Other | Patients with acute lower leg fractures with acute compartment syndrome. Receives: Procedure: Acute injury with compartment syndrome |
| Exertional compartment syndrome | Other | Patients with a diagnosis of exertional compartment syndrome who are planning to undergo surgical procedure to release the compartment fascia will be recruited to participate prior to surgical intervention. Receives: Procedure: Exertional compartment syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myostatin (% increase)
The investigators primary marker of interest is myostatin. The investigators will determine the (%) increase in myostatin levels in muscle tissues between compartment syndrome patients versus fracture controls. (%) increase in myostatin levels in muscle tissues between compartment syndrome patients versus patients with exertional compartment syndrome will also be determined. The measurement tool is polymerase chain reaction (PCR).
Measured: Immediately after the muscle tissue harvest procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start10 Jun 2022
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Shaft FractureStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Haller, University of Utah
- Investigators
- Justin Haller, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521958
- Sponsor's protocol ID
- 152310
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics and Local Gene Expression in Lower Extremity Acute Traumatic Compartment Syndrome
- ClinicalTrials.gov ID
- NCT05521958
- Acronym / sponsor ID
- 152310
- Conditions
- Tibial Shaft Fracture, Tibial Plateau Fracture
- Keywords
- tibial shaft or tibial plateau fracture, acute compartment syndrome, without acute compartment syndrome, exertional compartment syndrome, gene expression, myostatin
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Aug 2022 (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 purpose of this study is to evaluate both genotypic differences and differences in local gene expression in individuals who develop acute traumatic compartment syndrome relative to control patients with at-risk lower extremity fractures who do not develop compartment syndrome.
Detailed description
Acute compartment syndrome is associated with infection, contractures, fracture non-union, and chronic pain syndromes. The most common cause of acute compartment syndrome is fracture. Individuals with compartment syndrome associated with a lower extremity fracture have demonstrated worse patient reported outcome scores compared to individuals who suffer lower extremity fractures alone.
The pathophysiology of compartment syndrome has been traditionally described as loss of tissue perfusion and subsequent cellular anoxia related to supra-physiologic pressure within a closed myofascial space. Both animal and clinical studies have suggested that compartment syndrome develops when the intra-compartmental pressure approaches systemic diastolic blood pressure. However, other studies have demonstrated that high absolute compartment pressures and/or narrowed delta pressures have poor sensitivity for predicting compartment syndrome, suggesting that the pathophysiology of compartment syndrome is likely more complex than the currently accepted understanding of the disease process.
Animal models suggest that fracture promotes inflammation and exacerbates microvascular dysfunction, which may act synergistically with elevated intra-compartmental pressures to create clinical compartment syndrome. It is known that fracture causes microvascular damage and inflammation in surrounding muscle tissue. Several models have demonstrated that the microvascular environment in compartment syndrome is characterized by tenuous, intermittent blood supply to the musculature, which displays asymmetric microvascular dysfunction in response to elevated compartment pressures. Similarly, recent animal research has demonstrated that elevated intra-compartmental pressure is associated with a pro-inflammatory state, which directly contributes to skeletal muscle injury and may exacerbate microvascular injury.
It is unknown whether individual genomic and/or transcriptomic variability is clinically relevant with respect to response to fracture or the development of compartment syndrome. However, there is evidence from the vascular surgery literature in both animal and human models that individual variability in gene expression meaningfully affects skeletal muscle response to acute ischemia. The investigators hypothesize that there may be an individual pre-disposition to developing clinical compartment syndrome in the setting of at-risk fractures which manifests itself in the cellular response to inflammation and low grade ischemia. The overarching goal of this study is to characterize cellular level dysfunction in human compartment syndrome and to determine whether there are unique gene expression profiles associated with the development of clinical compartment syndrome. Specific aim 1 of this study is to compare genetic and transcriptomic differences individuals with high-risk tibia fractures who do not develop compartment syndrome and individuals with high-risk tibia fractures who do develop clinical compartment syndrome. Specific aim 2 of this study is to to compare genetic differences between acute compartment syndrome patients and chronic exertional compartment syndrome patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute tibial shaft or tibial plateau fractures without compartment syndrome | Other | Procedure: Acute injury without compartment syndromePatients with acute lower leg fractures who do not have clinical compartment syndrome. |
| Acute tibial shaft or tibial plateau fractures with compartment syndrome. | Other | Procedure: Acute injury with compartment syndromePatients with acute lower leg fractures with acute compartment syndrome. |
| Exertional compartment syndrome | Other | Procedure: Exertional compartment syndromePatients with a diagnosis of exertional compartment syndrome who are planning to undergo surgical procedure to release the compartment fascia will be recruited to participate prior to surgical intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient 18+ years of age. English speaking.
- Patients with the clinical diagnosis of lower leg acute compartment syndrome secondary to tibial shaft or tibial plateau fracture.
- Patients without clinical compartment syndrome undergoing operative intervention within 48 hours of injury for tibial shaft or tibial plateau fractures.
- Patients with the clinical diagnosis of exertional compartment syndrome with planned surgical intervention.
Key exclusion criteria (1 listed)
- Non-english speaking participants
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 |
|---|---|---|
| Acute injury without compartment syndromeAcute tibial shaft or tibial plateau fractures who do not have clinical compartment syndrome. Muscle punch biopsy of the anterior compartment will be taken. | Procedure or surgery | Acute tibial shaft or tibial plateau fractures without compartment syndrome |
| Acute injury with compartment syndromeAcute tibial shaft or tibial plateau fractures who have clinical compartment syndrome. Muscle punch biopsy of the anterior compartment will be taken. | Procedure or surgery | Acute tibial shaft or tibial plateau fractures with compartment syndrome. |
| Exertional compartment syndromeFor patients with exertional compartment syndrome, a muscle biopsy will be obtained from affected extremity. | Procedure or surgery | Exertional compartment syndrome |
Primary outcome
Myostatin (% increase)
Time frame: Immediately after the muscle tissue harvest procedure.
The investigators primary marker of interest is myostatin. The investigators will determine the (%) increase in myostatin levels in muscle tissues between compartment syndrome patients versus fracture controls. (%) increase in myostatin levels in muscle tissues between compartment syndrome patients versus patients with exertional compartment syndrome will also be determined. The measurement tool is polymerase chain reaction (PCR).
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 29 Apr 2026.
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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.
Justin Haller, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute injury without compartment syndrome, Acute injury with compartment syndrome and Exertional compartment syndrome in people with Tibial Shaft Fracture and Tibial Plateau Fracture, run by University of Utah 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 4 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 29 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myostatin (% increase) (time frame: Immediately after the muscle tissue harvest procedure.). 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 29 Apr 2026.