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Gene Expression for Compartment Syndrome
N/A
Waitlist Available
Led By Justin Haller, M.D.
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with the clinical diagnosis of exertional compartment syndrome with planned surgical intervention.
Patients without clinical compartment syndrome undergoing operative intervention within 48 hours of injury for tibial shaft or tibial plateau fractures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the muscle tissue harvest procedure.
Awards & highlights
Study Summary
This trial looks at whether there are genetic differences between people who develop a condition called acute traumatic compartment syndrome (ATCS) and those who don't, as well as whether there are differences in how the genes are expressed.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial focuses on observing genetic expressions rather than testing medications or interventions, there are no direct side effects associated with the study itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am diagnosed with exertional compartment syndrome and scheduled for surgery.
Select...
I am having surgery within 2 days for a broken shinbone without severe swelling.
Select...
I have acute compartment syndrome in my lower leg due to a tibia fracture.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after the muscle tissue harvest procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the muscle tissue harvest procedure.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Myostatin (% increase)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Exertional compartment syndromeExperimental Treatment1 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 syndromeExperimental Treatment1 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 Treatment1 Intervention
Patients with acute lower leg fractures with acute compartment syndrome.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,104 Previous Clinical Trials
1,782,453 Total Patients Enrolled
Justin Haller, M.D.Principal InvestigatorUniversity of Utah Orthopaedics
4 Previous Clinical Trials
265 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 do not speak English.I am over 18 years old and speak English.I have acute compartment syndrome in my lower leg due to a tibia fracture.
Research Study Groups:
This trial has the following groups:- Group 1: Acute tibial shaft or tibial plateau fractures with compartment syndrome.
- Group 2: Exertional compartment syndrome
- Group 3: Acute tibial shaft or tibial plateau fractures without compartment syndrome
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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