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This study examines the effect of using the PhysioStim bone growth stimulator on subjects undergoing treatment for ankle and hindfoot fusion surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEMF use adjunct to ankle/hindfoot fusion | This group will include subjects where PhysioStim (PEMF) is used adjunctively to an ankle/hindfoot fusion procedure. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Secondary surgeries | Rate of secondary surgeries (# subjects requiring additional surgeries / # eligible subjects) | For the period 12 months following the start of treatment |
| Safety endpoints | Incidence of device and procedure-related Adverse Events (AEs) and Serious Adverse Events (SAEs) through 12 months post-treatment. |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Foot Health | Phoenix | Arizona | 85028 | United States | ||
| Phoenix Foot and Ankle Institute |
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| Control | Other | Control (no PEMF) |
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| For the period 12 months following the start of treatment |
| Pain (NPRS) (0-100) | 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 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| OrthoArizona | Scottsdale | Arizona | 85258 | United States |
| Byron COllier DPM, Inc | Pismo Beach | California | 93449 | United States |
| East Village Foot and Ankle | Des Moines | Iowa | 50309 | United States |
| Precision Orthopedics and Sports Medicine | Laurel | Maryland | 20707 | United States |
| OrthoCarolina Research Institute, Inc | Charlotte | North Carolina | 28207 | United States |
| Lone Star Orthopaedic and Spine Specialists | Fort Worth | Texas | 76104 | United States |