Orthofix PhysioStim PEMF Ankle Fusion Retrospective

A Retrospective Study to Assess the Efficacy of PEMF Treatment in Ankle Fusion

This study examines the effect of using the PhysioStim bone growth stimulator on subjects undergoing treatment for ankle and hindfoot fusion surgery.

The objective of this investigation is to study the effect of using adjunctive PEMF treatment (via PhysioStim) in subjects undergoing ankle fusion, and also as nonoperative treatment for failed ankle fusion. The sponsor hypothesizes that use of PhysioStim will result in higher rates of fusion compared to that of control. In addition to analyzing the primary endpoint, the study will collect safety information to confirm the favorable safety profile established in prior device usage.

Inclusion Criteria:

• Condition requiring ankle fusion surgery or nonoperative treatment for failed ankle fusion
• Age 23 years or older
• Subjects must have a minimum of 6 months follow-up data or evidence of fusion, whichever occurs first

Exclusion Criteria:

• Subject is a prisoner