HP Arize 3D Orthotics for Planar Fasciitis

Plantar Fascitis Clinical Trial

Official title:

Comparing Efficacy Between Traditionally Fabricated Foot Orthotics and the HP Arize 3D Printed Foot Orthotics

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05707013
• Other study ID #: 1876792
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 19, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: July 2023
• Source: Prisma Health-Midlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Device:
• HP Arize 3D-Printed Orthotics
Custom 3D-printed orthotics manufactured by HP.
• Traditional Orthotics
Traditionally fabricated custom orthotics manufactured by a local supplier.

Locations

Country	Name	City	State
United States	Prisma Health - Midlands	Lexington	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Midlands	Hewlett-Packard (HP)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported compliance and satisfaction with orthotics.	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.	8 weeks
Secondary	Patient-reported secondary site pain following implementation of orthotics.	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.	8 weeks