Gene Expression for Compartment Syndrome

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Non-english speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some people develop compartment syndrome after a serious leg injury while others do not. Researchers will examine genetic and gene expression differences between those with and without compartment syndrome, as well as those with exertional compartment syndrome planning surgery. This trial may suit individuals who have recently experienced a severe leg fracture or are dealing with exertional compartment syndrome and are ready for surgery.

As an unphased trial, participants can contribute to groundbreaking research that may lead to improved prevention and treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that acute compartment syndrome requires quick treatment, usually with surgery. Without surgery, it can seriously damage muscles and nerves. The surgery, called a fasciotomy, might reduce muscle strength in the affected leg. While this addresses the immediate danger, some long-term issues might still occur.

For exertional compartment syndrome, which arises with exercise, surgery is also an option. Studies indicate that about 7% of patients might need another surgery, and 5% could experience complications. Some people continue to feel pain during exercise even after treatment. Satisfaction with surgery varies widely, from 42% to 94%, and the ability to return to sports ranges from 26% to 100%.

Evidence suggests that both conditions carry known risks and possible long-term effects. However, these treatments are generally necessary to prevent more serious problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the role of gene expression in different types of compartment syndrome. Unlike standard treatments, which typically involve surgical intervention to relieve pressure, this study explores the underlying genetic factors that might influence the development of compartment syndrome. Understanding these genetic markers could lead to earlier diagnosis, more targeted therapies, and prevent the need for invasive procedures. By identifying specific gene expressions associated with acute and exertional compartment syndromes, this trial has the potential to revolutionize how these conditions are treated in the future.

What evidence suggests that this trial's treatments could be effective for compartment syndrome?

This trial will study different types of compartment syndrome. Research has shown that for sudden injuries with compartment syndrome, improving tissue energy use can help reduce muscle damage from poor blood flow. Studies have found that certain injuries, like crush injuries, increase the risk of this condition. Participants in this trial with acute tibial fractures and compartment syndrome will be observed for these effects.

In cases of exertional compartment syndrome, a surgery called fasciotomy, which relieves pressure, greatly reduces pain and increases satisfaction for most patients. Over 84% of those treated return to sports. Participants with exertional compartment syndrome in this trial will undergo this surgical procedure. Each condition has its own treatment methods, but evidence supports their effectiveness in managing symptoms and improving outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Justin Haller, M.D.

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with lower leg injuries at risk of compartment syndrome. It includes those planning surgery for exertional compartment syndrome and patients with acute compartment syndrome from tibial fractures, as well as a control group without the syndrome.

Inclusion Criteria

I am diagnosed with exertional compartment syndrome and scheduled for surgery.

I am having surgery within 2 days for a broken shinbone without severe swelling.

I have acute compartment syndrome in my lower leg due to a tibia fracture.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tissue Harvesting

Muscle tissue is harvested for analysis of myostatin levels and gene expression profiles

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after tissue harvesting

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acute injury with compartment syndrome
• Acute injury without compartment syndrome
• Exertional compartment syndrome

Trial Overview The study aims to identify genetic differences by comparing gene expression in patients who develop acute traumatic compartment syndrome after a lower extremity injury to those who don't but have similar at-risk fractures.

How Is the Trial Designed?

Group I: Exertional compartment syndrome Experimental Treatment 1 Intervention

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.

Group II: Acute tibial shaft or tibial plateau fractures without compartment syndrome Experimental Treatment 1 Intervention

Patients with acute lower leg fractures who do not have clinical compartment syndrome.

Group III: Acute tibial shaft or tibial plateau fractures with compartment syndrome. Experimental Treatment 1 Intervention

Patients with acute lower leg fractures with acute compartment syndrome.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. withpower.com withpower.com/trial/phase-tibial-plateau-fracture-5-2022-6bef3

Gene Expression for 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35249740/

Big data insights into predictors of acute compartment ... Crush and penetrating injuries showed an important increase in the likelihood of ACS (O.R of 1.83 and 1.37 respectively). Additionally, sex, BMI, cirrhosis, ...

3. nature.com nature.com/articles/s41598-024-83796-4

Serum inflammation-related proteins in a acute ... We aim to explore variations of serum inflammation-related proteins in an acute compartment syndrome (ACS) rat model.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11796005/

Immune-mediated mechanisms in acute osteofascial ... Studies have shown that improving tissue metabolism can effectively alleviate skeletal muscle ischemia–reperfusion injury, increase muscle ...

5. researchgate.net researchgate.net/publication/381878903_Proteomics_analysis_of_deep_fascia_in_acute_compartment_syndrome

Proteomics analysis of deep fascia in acute compartment ... Therefore, the aim of the present study was to examine the differences in gene profile in deep fascia tissue in fracture patients of the calf ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK448124/

Acute Compartment Syndrome - StatPearls - NCBI Bookshelf Acute compartment syndrome is considered a surgical emergency since, without proper treatment, it can lead to ischemia and eventually necrosis. Generally, acute ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138306007108

Long term results of compartment syndrome of the lower ... In our study, compartment syndrome treated by fasciotomy led to impaired isokinetic muscle strength of the injured leg. There was no difference in muscle ...

8. uptodate.com uptodate.com/contents/acute-compartment-syndrome-of-the-extremities

Acute compartment syndrome of the extremities - UpToDate The most important determinant of a poor outcome from ACS is a delayed or missed diagnosis. ACS can result in muscle contracture, sensory ...

9. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-024-04719-7

Risk factors for poor outcomes in patients with acute lower leg ... The primary aim of this study was to investigate the risk factors associated with poor outcomes following acute compartment syndrome (ACS) of lower leg.

10. emedicine.medscape.com emedicine.medscape.com/article/307668-overview

Acute Compartment Syndrome Acute compartment syndrome occurs when the tissue pressure within a closed muscle compartment exceeds the perfusion pressure and results in muscle and nerve ...