HP Arize 3D Orthotics for Planar Fasciitis

Not Applicable

• Conditions: Plantar Fascitis
• Interventions: Device: Traditional Orthotics; Device: HP Arize 3D-Printed Orthotics

• Registration Number: NCT05707013
• Lead Sponsor: Prisma Health-Midlands

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-01-19
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11
• Primary Completion: 2025-01-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Orthotics	Traditional Orthotics	Patients will receive traditionally fabricated orthotics for treatment of plantar fasciitis.
HP Arize 3D-Printed Orthotics	HP Arize 3D-Printed Orthotics	Patients will receive the HP Arize 3D-printed orthotics for treatment of plantar fasciitis.

Primary Outcome Measures

Name	Time	Method
Patient-reported compliance and satisfaction with orthotics.	8 weeks	Patient-reported compliance with traditionally fabricated or 3D-printed orthotics will be assessed at 4 weeks and 8 weeks post-initiation of orthotic wearing via a study-specific survey. This survey includes questions related to how often the patient wore their orthotics, the ease of the process, and fit and feel of the orthotics, and any experienced side effects. This survey was developed by the research team and includes subjective responses to questions; there is no score associated with this assessment.

Secondary Outcome Measures

Name	Time	Method
Patient-reported secondary site pain following implementation of orthotics.	8 weeks	Patient-reported secondary site pain for patients wearing either traditionally fabricated or 3D-printed orthotics will be assessed at the time of consent, 4 weeks, and 8 weeks post-initiation of orthotic wearing via a study-specific survey. This survey asks patients to provide a pain score and function score for 11 locations on the body. Scores range from 0 to 100, with 0 being no pain or no limitation to physical function, and 100 being the worst pain possible or complete limitation to physical function.

Trial Locations

Locations (1)

Prisma Health - Midlands; 🇺🇸 Lexington, South Carolina, United States