Gene Expression in Lower Extremity Acute Traumatic Compartment Syndrome

NCT05521958 | Enrolling By Invitation DMC

• 1 other identifier: 152310
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately after the muscle tissue harvest procedure.

Study Arms (3)

Acute tibial shaft or tibial plateau fractures without compartment syndrome

OTHER

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

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.

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.

Procedure: Exertional compartment syndrome

Interventions

Acute injury without compartment syndrome PROCEDURE

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 tibial shaft or tibial plateau fractures without compartment syndrome

Exertional compartment syndrome PROCEDURE

For patients with exertional compartment syndrome, a muscle biopsy will be obtained from affected extremity.

Exertional compartment syndrome

Acute injury with compartment syndrome PROCEDURE

Acute tibial shaft or tibial plateau fractures who have clinical compartment syndrome. Muscle punch biopsy of the anterior compartment will be taken.

Acute tibial shaft or tibial plateau fractures with compartment syndrome.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-english speaking participants

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries; Tibial Fractures; Knee Injuries; Leg Injuries

Study Officials

• Justin Haller, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 30, 2022
• Study Start: June 10, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)