Diagnosing Compartment Syndrome With SHAPE vs Elastography
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
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[1], . 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
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Thomas Jefferson University
Collaborators:
Lantheus Medical Imaging Rothman Institute Orthopaedics