Testing a 3D printed prosthetic foot for amputees
Pilot Study to Assess Safety and Performances of a Energy Storing and Return (ESAR) Prosthetic Foot Made in Additive Manufacturing
This study tests a new 3D printed prosthetic foot to see if it helps people with below-knee amputations move better and feel more comfortable compared to their current prosthetic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro Academic / other |
| Locations | 1 site (Vigorso di Budrio, Bologna) |
| Trial ID | NCT06938087 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and performance of a dynamic energy storage and return foot prosthesis designed for individuals with below-knee amputations. The prosthesis utilizes additive manufacturing technology to create a highly customized device that mimics natural limb movement, allowing for improved mobility during daily activities. Participants will be compared using the new 3D printed prosthesis against their current prosthetic foot to assess functionality and comfort. The study aims to enhance the quality of life for amputees by providing a more efficient and effective prosthetic solution.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-65 with a unilateral below-knee amputation and a mobility level classified as K3 or K4.
Not a fit: Patients who are pregnant, unable to understand instructions, or have issues with their stump may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for lower limb amputees.
How similar studies have performed: While the use of 3D printing in prosthetics is gaining traction, this specific approach to dynamic energy storage and return has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Monolateral below knee amputation * Mobility level: K3 or K4 * Age: 18-65 years old * Maximum weigth: 100 Kg * Collaborative subject * Clinically stable stump Exclusion Criteria: * Pregnant * Not able to understand written and oral instructions * Problems to the stump
Where this trial is running
Vigorso di Budrio, Bologna
- Centro Protesi Inail — Vigorso di Budrio, Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.