HP Arize 3D Orthotics for Planar Fasciitis

Prisma Health-Midlands

Status: Active, not recruiting

Conditions: Plantar Fascitis

Treatments: Device: HP Arize 3D-Printed Orthotics; Device: Traditional Orthotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05707013

1876792

Details and patient eligibility

About

Currently 77% of Americans experience foot pain, of which a large portion can be attributed to plantar fasciitis.

The Arize Orthotic solution, developed in collaboration with podiatrists and leading industry experts, is a new digital solution that helps podiatrists create custom foot orthoses tailored to the patient, quickly, easily, accurately, and reliably. This pilot study will evaluate the effectiveness and clinical benefit of 3D printed foot orthotics compared to traditionally fabricated custom-made orthotics and assess compliance and patient satisfaction in patients with plantar fasciitis.

Full description

Currently 77% of Americans experience foot pain, of which a large portion can be attributed to plantar fasciitis. Approximately half of the people with foot pain do not consult a doctor due to cost, convenience, or insurance reasons. To this end, HP will implement an end-to-end system to provide 3D-printed custom orthotic inserts to patients in a fast and efficient manner via their podiatrist.

The Arize Orthotic solution developed in collaboration with podiatrists and leading industry experts, is a new digital solution that helps podiatrists create custom foot orthoses tailored to the patient, quickly, easily, accurately, and reliably. The Arize Orthotic Solution leverages HP 3D Printing technology and aims to further HP's mission to create technology that makes life better for everyone, everywhere.

This pilot study will evaluate the effectiveness and clinical benefit of 3D printed foot orthotics compared to traditionally fabricated custom-made orthotics and assess compliance and patient satisfaction in patients with plantar fasciitis.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Diagnosis of plantar fasciitis
• Access to methods of electronic communication (i.e., email)

Exclusion criteria

• Previously prescribed and/or used orthotic inserts
• Requires additional bracing of the lower leg
• Diagnosis of neuropathy, acute fracture, or stress fracture
• Pregnant women
• Non-English speakers
• Medicare patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

HP Arize 3D-Printed Orthotics

Experimental group

Description:

Patients will receive the HP Arize 3D-printed orthotics for treatment of plantar fasciitis.

Treatment:

Device: HP Arize 3D-Printed Orthotics

Traditional Orthotics

Active Comparator group

Description:

Patients will receive traditionally fabricated orthotics for treatment of plantar fasciitis.

Treatment:

Device: Traditional Orthotics