Orthofix PhysioStim PEMF Ankle Fusion Retrospective (PSAF)

December 22, 2025 updated by: Orthofix Inc.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Arizona Foot Health
      • Scottsdale, Arizona, United States, 85251
        • Phoenix Foot and Ankle Institute
      • Scottsdale, Arizona, United States, 85258
        • OrthoArizona
    • California
      • Pismo Beach, California, United States, 93449
        • Byron COllier DPM, Inc
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • East Village Foot and Ankle
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Precision Orthopedics and Sports Medicine
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute, Inc
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Lone Star Orthopaedic and Spine Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population will be males and females who underwent an ankle fusion procedure and were at least 23 years of age at the time of surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PEMF use adjunct to ankle/hindfoot fusion
This group will include subjects where PhysioStim (PEMF) is used adjunctively to an ankle/hindfoot fusion procedure.
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.
PEMF use for failed ankle/hindfoot fusion
This group will include subjects where PhysioStim (PEMF) is used to treat a failed ankle/hindfoot fusion procedure.
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.
Ankle/hindfoot fusion, no device (Control)
This group will include subjects where PhysioStim (PEMF) is NOT used adjunctively to an ankle/hindfoot fusion procedure. Subjects will be identified as those indicated to receive PEMF, but did not due to reasons such as insurance denial, patient declined to use the device, etc.
Other: Control
Control (no PEMF)
Failed ankle/hindfoot fusion, no device (Control)
This group will include subjects where PhysioStim (PEMF) is NOT used to treat a failed ankle/hindfoot fusion procedure. Subjects will be identified as those indicated to receive PEMF, but did not due to reasons such as insurance denial, patient declined to use the device, etc.
Other: Control
Control (no PEMF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months from the start of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary surgeries
Time Frame: For the period 12 months following the start of treatment
Rate of secondary surgeries (# subjects requiring additional surgeries / # eligible subjects)
For the period 12 months following the start of treatment
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.
For the period 12 months following the start of treatment
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.
Multiple, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthofix Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIP-PSAF-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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