NCT07282067

Orthofix PhysioStim PEMF Ankle Fusion Retrospective

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Orthofix Inc. · Industry
• Sex: All
• Age: 23 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Ankle Fusion
• Hindfoot Arthrodesis
• Ankle Arthrodesis
• Tibiotalar Arthrodesis

Interventions

Type	Name	Description
DEVICE	Pulsed electromagnetic field (PEMF) stimulation	Subjects treated with PEMF with be directed to use the device for 3 hours per day, up to 6 months or until no longer needed.
OTHER	Control	Control (no PEMF)

Timeline

• Start date: 2025-01-23
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-12-15
• Last updated: 2025-12-29

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study