Important advancement in pediatric diagnostics

Clinical study with Compremium's non-invasive method on 25 pediatric patients suggests an easy and secure approach that has the potential to eliminate the need for invasive measurement of suspected Acute Compartment Syndrome (ACS).

This new method objectifies and specifies the clinical findings and thus has the potential to eliminate the need for any invasive measurement of suspected ACS.
by compremium team

Background

Soft tissue swelling following limb fractures in pediatric patients is widely recognized as a risk factor for the development of acute compartment syndrome (ACS). Clinical assessment alone may be uncertain in specific cases. A recent proposal suggests a non-invasive ultrasound-based method for objectifying muscle compartment compressibility (the term relative elasticity is used in the study) for monitoring purposes. The hypothesis posits a robust correlation between soft-tissue swelling post-stabilization of upper limb fractures and compartment elasticity, as quantified through a novel ultrasound-based approach in pediatric trauma.

Patients and methods

In this prospective clinical study, children suffering from forearm fractures but not developing an ACS were included. The muscle compartment compressiblity of the m. flexor carpi ulnaris (muscle in the forearm) was assessed after surgical intervention by a non-invasive, ultrasound-based method resulting in a relative compressibility (%) in both the control (healthy limb) and study group (fractured limb). Soft-tissue swelling was categorized in four different levels (0–3) and correlated with the resulting compressiblity (%).

Results

The compressiblity in the study group (15.67%, SD ± 3.06) showed a significantly decreased level (p < 0.001) compared with the control (22.77%, SD ± 5.4). The categorized grade of soft tissue swelling resulted in a moderate correlation with the compressiblity (rs = 0.474).

Conclusions

The presented study appears to represent a novel non-invasive approach to assess the posttraumatic pressure changes in a muscle compartment after fracture stabilization. In this first clinical study in pediatric cases, this measurement method represents an easy, and secure approach that has the potential to substitute invasive measurement of suspected ACS in muscle compartment conditions.

Further investigations in larger cohorts are essential to validate its practicality in daily clinical settings and to affirm its anticipated reliability. Nonetheless, these encouraging findings mark a pivotal advancement in diagnostics and bear significant relevance in the market:

• First pediatric study comparing the compressibility of an injured forearm with a healthy forearm

• Excellent sensitivity of Compremium’s device to gauge the swelling of soft tissues in children’s forearms after forearm fractures (> palpation)

• Sizable database (25 patients, 3 repetitions, healthy/injured side = 150 single measurements)

• No side effects reported

Sellei, R.M., Beckers, A., Kobbe, P. et al. Non-invasive assessment of muscle compartment elasticity by pressure-related ultrasound in pediatric trauma: a prospective clinical study in 25 cases of forearm shaft fractures. Eur J Med Res 28, 296 (2023). https://doi.org/10.1186/s40001-023-01232-1