Comparing Efficacy Between Traditionally Fabricated Foot Orthotics and the HP Arize 3D Printed Foot Orthotics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Prisma Health-Midlands
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Patient-reported compliance and satisfaction with orthotics.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HP Arize 3D-Printed Orthotics
Patients will receive the HP Arize 3D-printed orthotics for treatment of plantar fasciitis.
Intervention: HP Arize 3D-Printed Orthotics (Device)
Traditional Orthotics
Patients will receive traditionally fabricated orthotics for treatment of plantar fasciitis.
Intervention: Traditional Orthotics (Device)
Outcomes
Primary Outcomes
Patient-reported compliance and satisfaction with orthotics.
Time Frame: 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 Outcomes
- Patient-reported secondary site pain following implementation of orthotics.(8 weeks)