Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07282067

Orthofix PhysioStim PEMF Ankle Fusion Retrospective

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Ankle Fusion Ankle Arthrodesis Hindfoot Arthrodesis Tibiotalar Arthrodesis

Age range

23 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Foot Health, Phoenix, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed electromagnetic field (PEMF) stimulation

Device

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.

Control

Other

Control (no PEMF)

Primary outcomes

  1. Radiographic fusion rate at 6 months post treatment

    Time frame: 6 months from the start of treatment

    Fusion rate (# subjects fused / # total evaluable subjects) based on radiographic assessment.

Other outcomes

  1. Secondary surgeries

    Time frame: For the period 12 months following the start of treatment

    Rate of secondary surgeries (# subjects requiring additional surgeries / # eligible subjects)

  2. Safety endpoints

    Time frame: For the period 12 months following the start of treatment

    Incidence of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs) through 12 months post-treatment.

  3. Pain (NPRS) (0-100)

    Time frame: Multiple, up to 12 months

    Pain reduction using Numerical Pain Rating Scale (NPRS) will be reported at multiple time points, as available. 0-100 pain scale is used where 100 is maximum pain.

Sponsors and collaborators

Lead sponsor

Orthofix Inc.

Industry

Registry information

Official study title

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

Acronym: PSAF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.