Diagnosing Compartment Syndrome With SHAPE vs Elastography

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborators: Lantheus Medical Imaging; Rothman Institute Orthopaedics

Criteria

Inclusion Criteria:

• CECS as the primary diagnosis with no other more likely diagnoses.

• Age over 18.

Exclusion Criteria:

• Medial tibial stress syndrome or tibial stress fractures diagnosed on MRI.

• Recent trauma/surgery to the lower extremity

• Pregnant

• Stress fractures of the lower extremity

• Diabetic neuropathy

• Peripheral vascular disease

• Pressure ulcers or treatment for pressure ulcers

• Coronary artery disease

• Active pulmonary disease

• Allergy to any components of Definity.