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.
Study Type
OBSERVATIONAL
Enrollment
200
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 (no PEMF)
Arizona Foot Health
Phoenix, Arizona, United States
Phoenix Foot and Ankle Institute
Scottsdale, Arizona, United States
OrthoArizona
Scottsdale, Arizona, United States
Byron COllier DPM, Inc
Pismo Beach, California, United States
Radiographic fusion rate at 6 months post treatment
Fusion rate (# subjects fused / # total evaluable subjects) based on radiographic assessment.
Time frame: 6 months from the start of treatment
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East Village Foot and Ankle
Des Moines, Iowa, United States
Precision Orthopedics and Sports Medicine
Laurel, Maryland, United States
OrthoCarolina Research Institute, Inc
Charlotte, North Carolina, United States
Lone Star Orthopaedic and Spine Specialists
Fort Worth, Texas, United States