Orthofix PhysioStim PEMF Ankle Fusion Retrospective

NCT07282067 | Active Not Recruiting FDA Device

• 1 other identifier: CIP-PSAF-24
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Hindfoot Arthrodesis; Ankle Arthrodesis; Tibiotalar Arthrodesis; Ankle Fusion

Keywords

ankle; tibiotalar; PEMF; hindfoot; pulsed electromagnetic fields; Orthofix

Outcome Measures

Primary Outcomes (1)

• Radiographic fusion rate at 6 months post treatment

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

  6 months from the start of treatment

Other Outcomes (3)

• Secondary surgeries

  For the period 12 months following the start of treatment

• Safety endpoints

  For the period 12 months following the start of treatment

• Pain (NPRS) (0-100)

  Multiple, up to 12 months

Study Arms (4)

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

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

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

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

Interventions

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.

PEMF use adjunct to ankle/hindfoot fusion; PEMF use for failed ankle/hindfoot fusion

Control OTHER

Control (no PEMF)

Ankle/hindfoot fusion, no device (Control); Failed ankle/hindfoot fusion, no device (Control)

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subject is a prisoner

Sponsors & Collaborators

• Orthofix Inc.: lead

Study Sites (8)

Arizona Foot Health

Phoenix, Arizona, 85028, United States

Location

Phoenix Foot and Ankle Institute

Scottsdale, Arizona, 85251, United States

Location

OrthoArizona

Scottsdale, Arizona, 85258, United States

Location

Byron COllier DPM, Inc

Pismo Beach, California, 93449, United States

Location

East Village Foot and Ankle

Des Moines, Iowa, 50309, United States

Location

Precision Orthopedics and Sports Medicine

Laurel, Maryland, 20707, United States

Location

OrthoCarolina Research Institute, Inc

Charlotte, North Carolina, 28207, United States

Location

Lone Star Orthopaedic and Spine Specialists

Fort Worth, Texas, 76104, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: January 23, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (8)