Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study

NCT ID: NCT06938087

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-28
• Study Completion Date: 2025-04-17

Brief Summary

A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated. This type of prosthesis is designed to allow patients to perform daily activities, even very dynamic ones, with greater ease and efficiency. The distinguishing feature of a dynamic energy storage and return prosthesis is the presence of a system that accumulates mechanical energy during the support phase on the ground and returns it during the push phase, increasing the amount of push itself. In foot prostheses, it is common to use carbon fiber blades or springs that deform during the support of the foot and then restore themselves, returning elastic energy during the subsequent push. This helps reduce the effort required to walk and allows for more fluid and natural movements. Additive Manufacturing (AM) technology is ideal for highly customized and high-value production. Orthoses/prostheses are particularly suited to exploit the potential of this technology. However, the lack of functional materials that meet different design needs, such as structure and comfort of the devices, has limited the use of AM mainly in orthoses. AM is promising for orthoses due to its customization capability and reduced production costs compared to traditional solutions. In particular, it has been shown how continuous filament carbon printing can lead to the creation of prostheses that have dynamic and energy return characteristics similar to or even superior to commercial ones. The present pilot clinical investigation aims to provide indications regarding the safety and performance of the 3D printed prosthesis - named PROFIL - in a real-world scenario. The state of the art has not yet defined the performance and safety of 3D printed prostheses with thermoplastic materials and continuous carbon fiber. Since greater comfort and the possibility of performing physical activity more easily with the use of these devices is expected, it is considered of interest for clinical practice to evaluate these prostheses. The primary objective of the study is therefore to evaluate the safety and performance of the device during walking on flat surfaces and more demanding tasks. The secondary objectives aims at evaluate usability and deformation of the 3D printed prosthesis under different loading conditions (slow and fast walking, ascending and descending ramps or steps) by mean of fiber-glass sensors integrated in the prosthesis foot.

Conditions

Amputation of Lower Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PROFIL prosthesis foot

Recruited subjects with below kenen amputation wearing the experimental prosthesis foot (PROFIL)

Group Type: EXPERIMENTAL

3D printed prosthesis foot

Intervention Type: DEVICE

Energy storage and restoration 3D printed prosthesis foot

Current prosthesis foot (PROFLEX XC)

Recruited subjects with below knee amputation wearing the currently used prosthesis foot (PROFIL)

Group Type: ACTIVE_COMPARATOR

Current prosthesis foot

Intervention Type: DEVICE

Energy storage and restitution prosthesis foot made in carbon fibers blades

Interventions

3D printed prosthesis foot

Energy storage and restoration 3D printed prosthesis foot

Intervention Type: DEVICE

Current prosthesis foot

Energy storage and restitution prosthesis foot made in carbon fibers blades

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto per i Polimeri Compositi e Biomateriali (CNR-IPCB)

UNKNOWN

Sponsor Role: collaborator

Istituto di Chimica della Materia Condensata e di Tecnologie per l'Energia (CNR-ICMATE)

UNKNOWN

Sponsor Role: collaborator

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

OTHER

Sponsor Role: lead

Responsible Party

Emanuele Gruppioni

Engineer, Orthopaedic Techinician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro Protesi Inail

Vigorso Di Budrio, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Emanuele Gruppioni, Ph.D

Role: primary

e.gruppioni@inail.it

+39 051 6936609

Giovanni Hamoui, Orthopaedic Technician

Role: backup

g.hamoui@inail.it

References

Manero A, Smith P, Sparkman J, Dombrowski M, Courbin D, Kester A, Womack I, Chi A. Implementation of 3D Printing Technology in the Field of Prosthetics: Past, Present, and Future. Int J Environ Res Public Health. 2019 May 10;16(9):1641. doi: 10.3390/ijerph16091641.

Reference Type: BACKGROUND

PMID: 31083479 (View on PubMed)

South BJ, Fey NP, Bosker G, Neptune RR. Manufacture of energy storage and return prosthetic feet using selective laser sintering. J Biomech Eng. 2010 Jan;132(1):015001. doi: 10.1115/1.4000166.

Reference Type: BACKGROUND

PMID: 20524754 (View on PubMed)

Klute GK, Berge JS, Orendurff MS, Williams RM, Czerniecki JM. Prosthetic intervention effects on activity of lower-extremity amputees. Arch Phys Med Rehabil. 2006 May;87(5):717-22. doi: 10.1016/j.apmr.2006.02.007.

Reference Type: BACKGROUND

PMID: 16635636 (View on PubMed)

Versluys R, Beyl P, Van Damme M, Desomer A, Van Ham R, Lefeber D. Prosthetic feet: state-of-the-art review and the importance of mimicking human ankle-foot biomechanics. Disabil Rehabil Assist Technol. 2009 Mar;4(2):65-75. doi: 10.1080/17483100802715092.

Reference Type: BACKGROUND

PMID: 19253096 (View on PubMed)

Hafner BJ, Sanders JE, Czerniecki J, Fergason J. Energy storage and return prostheses: does patient perception correlate with biomechanical analysis? Clin Biomech (Bristol). 2002 Jun;17(5):325-44. doi: 10.1016/s0268-0033(02)00020-7.

Reference Type: BACKGROUND

PMID: 12084537 (View on PubMed)

Other Identifiers

CP-PAI-01-23

Identifier Type: -

Identifier Source: org_study_id