Clinical trial NCT06938087: Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study
Official title: Pilot Study to Assess Safety and Performances of a Energy Storing and Return (ESAR) Prosthetic Foot Made in Additive Manufacturing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation of Lower Limb
Keywords: Safety
Lower limb amputation
Additive manufacturing
Prosthesis foot
Performances
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
Collaborators: name: Istituto per i Polimeri Compositi e Biomateriali (CNR-IPCB)
name: Istituto di Chimica della Materia Condensata e di Tecnologie per l'Energia (CNR-ICMATE)
First posted: 2025-04-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of adverse events occurred during use of the Intervention prosthesis foot
timeFrame: Day 1 and Day 2
measure: Change from Comparator of joints kinematics measured with Inertial Measurements Units (IMUs) placed on subject lower leg, upper arms and trunk
timeFrame: Day 1 and Day 2
measure: Change from Comparator of joints kinematics and dymamics measured with an optoelectronic system
timeFrame: Day 1 and Day 2
measure: Change from Comparator of gait quality wihile ascending ramps with Hill Assessment Index (HAI)
timeFrame: Day 1 and Day 2
measure: Change from Comparator of gait quality while ascending stairs with Stair Ascending Index (SAI)
timeFrame: Day 1 and Day 2
measure: Change from Comparator of equilibrium in orthostatism by mean of force plates
timeFrame: Day 1 and Day 2
measure: Change from Comparator of load simmetry while standing up/sitting down from/on a chiar by mean of force plates
timeFrame: Day 1 and Day 2
measure: Change from Comparator of subject mobility with prosthesis by mean of the Amputee Mobility Predictor (AMP)
timeFrame: Day 1 and Day 2
measure: Change form Comparator of functional mobility measured with the L-test
timeFrame: Day 1 and Day 2
Secondary outcomes:
measure: Change from Comparator of usability of the prosthesis foot
timeFrame: Day 1 and Day 2
Other outcomes:
Locations:
city: Vigorso di Budrio
country: Italy
facility: Centro Protesi Inail
state: Bologna
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.