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Diagnosing Compartment Syndrome With SHAPE vs Elastography

NCT05247541 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-12-12

No results posted yet for this study

Summary

Chronic exertional compartment syndrome (CECS) is an innocuous condition seen primarily in 10-60% of young active people with exercise induced leg pain. With an average delay in diagnosis of 2 years, early identification is crucial as delays have led to poor surgical outcomes after fasciotomy. Diagnosis is currently made by compartment pressure (CP) testing, which is invasive, painful and demonstrates variable accuracy. There is no literature on the role of shear wave elastography (SWE) and/or subharmonic assisted pressure estimation (SHAPE) with microbubbles in diagnosing CECS. Ultrasound contrast agents are FDA-approved and are extremely safe. In this single-blinded prospective pilot study, the accuracy of SHAPE and SWE will be evaluated and compared to the current gold standard of compartment testing in patients with suspected CECS. Muscle stiffness and record a quantitative assessment of enhancement and hydrostatic pressures will be documented and correlated with compartment testing results based on a reference standard modified Pedowitz criteria for CECS

Conditions

  • Chronic Exertional Compartment Syndrome

Interventions

DRUG

Definity

Definity (Lantheus Medical Imaging, N Billerica, MA) in 50 mL of saline infused over 5-10 minutes

Sponsors & Collaborators

  • Lantheus Medical Imaging

    collaborator INDUSTRY

  • Rothman Institute Orthopaedics

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Flemming Forsberg, PhD · Thomas Jefferson University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2023-03-01
Completion
2023-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05247541 on ClinicalTrials.gov