Orthofix PhysioStim PEMF Ankle Fusion Retrospective (PSAF)

Orthofix

Status: Active, not recruiting

Conditions: Ankle Fusion; Tibiotalar Arthrodesis; Hindfoot Arthrodesis; Ankle Arthrodesis

Treatments: Other: Control; Device: Pulsed electromagnetic field (PEMF) stimulation

Study type: Observational

Funder types: Industry

Identifiers

NCT07282067

CIP-PSAF-24

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 23+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

PEMF use adjunct to ankle/hindfoot fusion

Description:

This group will include subjects where PhysioStim (PEMF) is used adjunctively to an ankle/hindfoot fusion procedure.

Treatment:

Device: Pulsed electromagnetic field (PEMF) stimulation

PEMF use for failed ankle/hindfoot fusion

Description:

This group will include subjects where PhysioStim (PEMF) is used to treat a failed ankle/hindfoot fusion procedure.

Treatment:

Device: Pulsed electromagnetic field (PEMF) stimulation

Ankle/hindfoot fusion, no device (Control)

Description:

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.

Treatment:

Other: Control

Failed ankle/hindfoot fusion, no device (Control)

Description:

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.

Treatment:

Other: Control