Ankle FusionPSAFNCT07282067
Orthofix PhysioStim PEMF Ankle Fusion Retrospective
An observational study of Ankle Fusion and Hindfoot Arthrodesis, run by Orthofix Inc. at 8 sites in United States.
Trial summary
This study examines the effect of using the PhysioStim bone growth stimulator on subjects undergoing treatment for ankle and hindfoot fusion surgery. Read more about this study
- Who is it for?
- Ages 23 years and older
- Conditions the study is for
- Ankle Fusion, Hindfoot Arthrodesis, Ankle Arthrodesis
- What is being tested?
- Pulsed electromagnetic field (PEMF) stimulation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Jan 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Subject is a prisoner
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
OrthoCarolina Research Institute, Inc
Charlotte, North Carolina, 28207
East Village Foot and Ankle
Des Moines, Iowa, 50309
Lone Star Orthopaedic and Spine Specialists
Fort Worth, Texas, 76104
Precision Orthopedics and Sports Medicine
Laurel, Maryland, 20707
Arizona Foot Health
Phoenix, Arizona, 85028
Byron COllier DPM, Inc
Pismo Beach, California, 93449
Phoenix Foot and Ankle Institute
Scottsdale, Arizona, 85251
OrthoArizona
Scottsdale, Arizona, 85258
About this study
Official title: 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.
Read the 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.
- Being tested
- Pulsed electromagnetic field (PEMF) stimulation, Control
- Keywords
- ankle, tibiotalar, PEMF, hindfoot, pulsed electromagnetic fields, Orthofix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic field (PEMF) stimulationDevice
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.
ControlOther
Control (no PEMF)
| Study group | Role | What they receive |
|---|---|---|
| PEMF use adjunct to ankle/hindfoot fusion | This group will include subjects where PhysioStim (PEMF) is used adjunctively to an ankle/hindfoot fusion procedure. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic fusion rate at 6 months post treatment
Fusion rate (# subjects fused / # total evaluable subjects) based on radiographic assessment.
Measured: 6 months from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start23 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282067
- Sponsor's protocol ID
- CIP-PSAF-24
- Acronym
- PSAF
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Assess the Efficacy of PEMF Treatment in Ankle Fusion
- ClinicalTrials.gov ID
- NCT07282067
- Acronym / sponsor ID
- PSAF / CIP-PSAF-24
- Keywords
- ankle, tibiotalar, PEMF, hindfoot, pulsed electromagnetic fields, Orthofix
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEMF use adjunct to ankle/hindfoot fusion | – | Device: Pulsed electromagnetic field (PEMF) stimulationThis group will include subjects where PhysioStim (PEMF) is used adjunctively to an ankle/hindfoot fusion procedure. |
| PEMF use for failed ankle/hindfoot fusion | – | Device: Pulsed electromagnetic field (PEMF) stimulationThis group will include subjects where PhysioStim (PEMF) is used to treat a failed ankle/hindfoot fusion procedure. |
| Ankle/hindfoot fusion, no device (Control) | – | Other: ControlThis 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. |
| Failed ankle/hindfoot fusion, no device (Control) | – | Other: ControlThis 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. |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subject is a prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed electromagnetic field (PEMF) stimulationSubjects treated with PEMF with be directed to use the device for 3 hours per day, up to 6 months or until no longer needed. | Device | PEMF use adjunct to ankle/hindfoot fusion, PEMF use for failed ankle/hindfoot fusion |
| ControlControl (no PEMF) | Other | Ankle/hindfoot fusion, no device (Control), Failed ankle/hindfoot fusion, no device (Control) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Ankle Fusion
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Recruiting
A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions.
Ankle Arthrodesis or Arthroplasty, Hindfoot Fusion
Active, not recruitingEarly Phase 1
Temporal Profile of Serum Vitamin D Levels in Foot and Ankle Fusion Surgery
Ankle Arthrodesis, MTP Arthrodesis
RecruitingPhase 4
Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Tourniquet Hypertension, Intraoperative Hypertension
RecruitingObservational study
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fusion and Hindfoot Arthrodesis, run by Orthofix Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic fusion rate at 6 months post treatment (time frame: 6 months from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.