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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of this treatment for compartment syndrome?

The research highlights that understanding gene expression in muscle injuries can help develop new strategies for recovery, which may be relevant for treating compartment syndrome. Specifically, identifying genes involved in muscle repair and inflammation could inform treatments that accelerate healing in similar conditions. ^{1 2 3 4 5}

Is the treatment for compartment syndrome generally safe in humans?

The research does not provide specific safety data for treatments related to compartment syndrome, but it highlights the importance of timely diagnosis and treatment to avoid serious complications. Surgical intervention, such as fasciotomy (a procedure to relieve pressure), is mentioned as a necessary treatment for true compartment syndromes. ^{6 7 8 9 10}

How does the gene expression treatment for compartment syndrome differ from other treatments?

This treatment is unique because it focuses on understanding and manipulating gene expression patterns specific to different types of muscle injuries, which could lead to more targeted and effective recovery strategies compared to traditional treatments that do not consider the specific molecular pathways involved. ^{2 3 4 5 11}

Research Team

Justin Haller, M.D.

Principal Investigator

University of Utah Orthopaedics

Eligibility Criteria

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 am over 18 years old and speak English.

Exclusion Criteria

I do not speak English.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Time course of skeletal muscle repair and gene expression following acute hind limb ischemia in mice. [2009]

2. England pubmed.ncbi.nlm.nih.gov

Mechanisms of skeletal muscle injury and repair revealed by gene expression studies in mouse models. [2022]

3. England pubmed.ncbi.nlm.nih.gov

In vivo Monitoring of Transcriptional Dynamics After Lower-Limb Muscle Injury Enables Quantitative Classification of Healing. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Targeting Hub Genes Involved in Muscle Injury Induced by Jumping Load Based on Transcriptomics. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Systematic Identification of the Optimal Housekeeping Genes for Accurate Transcriptomic and Proteomic Profiling of Tissues following Complex Traumatic Injury. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A comparison of anterior compartment pressures in competitive runners and cyclists. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Acute exertional anterior compartment syndrome in an adolescent female. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Sex and gender differences in lower limb chronic exertional compartment syndrome: a systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Surgical Management of Chronic Exertional Compartment Syndrome of the Lower Extremity: Outcome Analysis and Return to Sport. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Acute Exertional Compartment Syndrome in Young Athletes: A Descriptive Case Series and Review of the Literature. [2018]

11. Ireland pubmed.ncbi.nlm.nih.gov

HIF-VEGF-VEGFR-2, TNF-alpha and IGF pathways are upregulated in critical human skeletal muscle ischemia as studied with DNA array. [2009]