Ankle Arthrodesis, Ankle Fusion, Hindfoot Arthrodesis, Tibiotalar Arthrodesis
Conditions
Keywords
ankle, tibiotalar, PEMF, hindfoot, pulsed electromagnetic fields, Orthofix
Brief summary
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.
Interventions
DEVICEPulsed 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.
OTHERControl
Control (no PEMF)
Sponsors
Orthofix Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
23 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic fusion rate at 6 months post treatment | 6 months from the start of treatment | Fusion rate (# subjects fused / # total evaluable subjects) based on radiographic assessment. |
Countries
United States
Outcome results
None listed