3D Printed Prostheses for Upper Extremity Deformities

Overseen By Jorge M Zuniga, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Recent injury, Skin abrasions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how 3D printed prostheses affect the brain activity and movement skills of children with upper limb differences, such as missing fingers or arms. Researchers use a special tool called fNIRS (functional near-infrared spectroscopy) to understand how these prostheses influence motor skills and brain function in children. Insights gained could lead to improved rehabilitation programs, preventing children from abandoning their prostheses. Children aged 3-18 with upper limb differences and no recent injuries might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for children with limb differences.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that 3D printed prostheses are safe for children with upper extremity deformities?

Research has shown that 3D-printed upper-limb prostheses are popular due to their affordability and customization options. However, detailed safety information remains limited. Early studies suggest these prostheses could offer a promising, low-cost, and personalized solution for children with limb differences. Despite their positive reception, large-scale studies have not yet fully assessed their safety. This lack of extensive research does not imply they are unsafe, but further investigation is necessary to confirm their safety and effectiveness. Prospective trial participants should discuss any concerns with the research team and weigh the benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D printed prostheses for upper extremity deformities because they offer a customizable and cost-effective alternative to traditional prosthetic limbs. Unlike conventional prosthetics, which can be expensive and require extensive customization, 3D printing allows for rapid production tailored to individual needs, potentially reducing costs and wait times. Additionally, these prostheses can be easily adjusted and upgraded as children grow, providing a dynamic solution that evolves with the user.

What evidence suggests that 3D printed prostheses are effective for upper extremity deformities?

This trial will evaluate the effectiveness of 3D-printed upper limb prostheses for children with unilateral congenital upper-limb reductions. Studies have shown that these prostheses can help users move their arms and hands more easily. Research indicates that users often feel more satisfied because the prostheses fit well and are affordable. Some studies also highlight improvements in users' daily activities and overall quality of life. Although concerns exist about the durability of the materials, the overall effectiveness of these prostheses appears promising. They offer a unique opportunity to create prosthetic arms that are both attractive and functional, tailored to individual needs. ^{1 4 6 7 8}

Who Is on the Research Team?

Jorge M Zuniga, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for children and teens aged 3-18 with missing digits or parts of their arm due to conditions like Amniotic Band Syndrome. They should be able to wear a prosthetic but can't join if they have recent injuries, skin issues, or other medical problems that make using a prosthetic difficult.

Inclusion Criteria

I have problems with the movement or function of my arms or hands.

I am missing a digit, hand, arm, or shoulder.

Exclusion Criteria

I am not within the specified age range for the trial.

I don't have skin or muscle issues that prevent wearing a prosthetic.

I have had an injury to my arm or hand in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Measurement

Participants attend an initial session for 3D scanning and anthropometric measurements

1 session

1 visit (in-person)

Treatment and Testing

Participants are fitted with the prosthesis and undergo various tests including the Box and Block Test and bimanual coordination test

8 weeks

2 visits (in-person), 3 home visits per week

Follow-up

Participants are monitored for changes in brain hemodynamic responses, hand movement synchrony, hemispheric dominance, and movement duration

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D Printed Upper-limb Prosthesis
• Home Intervention

Trial Overview The study tests how cool-looking, custom-made 3D printed upper-limb prostheses affect brain activity related to movement in kids. Researchers will use special imaging (fNIRS) to see changes in the motor cortex when these prostheses are used.

How Is the Trial Designed?

Group I: 3D Prostheses Users Experimental Treatment 2 Interventions

Children with unilateral congenital upper-limb reductions

Group II: Typically Developing Children Active Control 1 Intervention

Age- and sex-matched control group of typically developing children.

3D Printed Upper-limb Prosthesis is already approved in United States for the following indications:

Approved in United States as 3D Printed Prosthetic Limb for:

• Congenital upper limb reductions
• Traumatic upper limb differences

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

A remote fitting procedure for 3D printed upper limb prostheses was assessed for patient satisfaction, showing high satisfaction scores for weight, safety, and ease of use among participants, including six children and two adults.

The study indicates that remote fitting could enhance access to functional prostheses in developing countries, leveraging the growing availability of digital devices in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote fitting procedures for upper limb 3d printed prostheses. Zuniga, JM., Young, KJ., Peck, JL., et al.[2019]

A study involving 11 children (ages 3-15) showed that using a 3D-printed transitional prosthesis for about 24 weeks significantly improved their manual gross dexterity, indicating enhanced functional ability.

While the prosthesis improved dexterity, it did not show a significant impact on wrist strength, suggesting that while these devices can aid in function, they may not necessarily enhance strength in the same timeframe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional changes through the usage of 3D-printed transitional prostheses in children. Zuniga, JM., Peck, JL., Srivastava, R., et al.[2020]

3D printed orthoses for upper extremity musculoskeletal conditions have been found to be comfortable, provide adequate immobilization, and are aesthetically pleasing, based on a review of 10 studies including various study designs.

Despite their effectiveness, the high cost of 3D printing equipment, the need for specialized software and scanning tools, and the lack of skilled clinicians pose significant challenges to their widespread implementation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of 3D printed orthoses for musculoskeletal conditions of the upper extremity: A systematic review. Schwartz, DA., Schofield, KA.[2023]

Recent advancements in upper extremity prosthetic technology have greatly improved the functionality of prosthetic devices, making them more similar to natural limbs.

Despite these improvements, there are still significant challenges that need to be addressed for further development of upper limb prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of upper limb prostheses: current progress and areas for growth. González-Fernández, M.[2022]

The review analyzed 58 different 3D-printed upper limb prostheses, highlighting their specifications and the types of 3D-printing technology used, with costs reaching up to $500.

While 3D-printing offers customization options for prostheses, such as personalized design and fit, it is not always the most cost-effective method compared to traditional manufacturing like injection molding, and there is limited evidence on user acceptance and durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D-printed upper limb prostheses: a review. Ten Kate, J., Smit, G., Breedveld, P.[2018]

3D printing technology can significantly reduce the cost and improve the accessibility of prosthetic devices for children with limb differences, making it easier for them to obtain customized solutions.

Children with upper limb differences benefit particularly from 3D-printed prostheses due to their rapid growth and tendency to damage devices, allowing for more affordable repairs and upgrades.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in 3D-Printed Pediatric Prostheses for Upper Extremity Differences. Tanaka, KS., Lightdale-Miric, N.[2022]

The newly developed three-dimensional printed prosthesis for patients with transradial limb amputation is cost-effective at approximately $300 and allows for independent movement of all five fingers and the thumb, enhancing functionality for users.

Testing on a patient showed that the prosthesis is lightweight and easily adjustable in size, making it a practical option for children, although it has limitations in grip strength and durability compared to traditional passive prosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of novel 3D-printed robotic prosthetic for transradial amputees. Gretsch, KF., Lather, HD., Peddada, KV., et al.[2022]

A low-cost, three-dimensional printed shoulder prosthesis was developed to assist individuals with forequarter amputations, showing promise in improving balance and performance in bi-manual activities after just two weeks of use.

The prototype demonstrated some benefits, such as partial correction of spinal deviation, but had limitations in grip strength and durability, indicating it is best used as a transitional device before more advanced prosthetic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of a low-cost three-dimensional printed shoulder, arm, and hand prostheses for children. Zuniga, JM., Carson, AM., Peck, JM., et al.[2022]

A systematic review of 51 studies involving 355 patients highlights the growing use of 3D printing in upper extremity surgery, particularly for trauma cases, with applications including intraoperative templates, body implants, and preoperative planning.

The findings suggest that 3D printing can enhance personalized surgical approaches, potentially improving patient outcomes and quality of life in upper extremity surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Applications of Three-Dimensional Printing in Upper Extremity Surgery: A Systematic Review. Hecker, A., Tax, L., Giese, B., et al.[2023]

A 3D-printed prosthetic hand was successfully created for an 8-year-old boy with a traumatic wrist amputation, costing less than $20 and taking under 8 hours to print, demonstrating a cost-effective solution for prosthetics in developing countries.

The prosthesis showed significantly improved function during follow-up assessments, indicating that 3D printing can provide effective and personalized rehabilitation options for children with amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional-printed upper limb prosthesis for a child with traumatic amputation of right wrist: A case report. Xu, G., Gao, L., Tao, K., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28152642/

3D-printed upper limb prostheses: a review This paper aims to provide an overview with quantitative information of existing 3D-printed upper limb prostheses.

2. mdpi.com mdpi.com/2079-4983/16/10/370

The Current State of 3D-Printed Prostheses Clinical ... The main clinical outcomes analyzed were functional performance, design and material integrity, and overall effectiveness of 3D-printed prostheses. Studies on ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/17483107.2016.1253117

Full article: 3D-printed upper limb prostheses: a review This paper aims to provide an overview with quantitative information of existing 3D-printed upper limb prostheses.

4. researchgate.net researchgate.net/publication/396104674_The_Current_State_of_3D-Printed_Prostheses_Clinical_Outcomes_A_Systematic_Review

The Current State of 3D-Printed Prostheses Clinical ... Studies on upper limb prostheses reported improved dexterity, range of motion (ROM), and user satisfaction, despite some durability limitations.

5. withpower.com withpower.com/trial/phase-upper-extremity-deformities-congenital-2020-a7d90

3D Printed Prostheses for Upper Extremity Deformities The 3D Printed Upper-limb Prosthesis is unique because it uses three-dimensional printing technology to create customized, low-cost prosthetic limbs, making ...

6. mdpi.com mdpi.com/2673-1592/7/2/39

Shaping the Future of Upper Extremity Prostheses Through ... This review examines the current landscape of 3D-printed upper limb prostheses, focusing on their design, functionality, and cost-effectiveness.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352550925001253

Analysis of the environmental impacts generated by an ... This work aims to analyze the environmental impacts of 3D upper limb prostheses through life cycle assessment methodology, analyzing designs for children, ...

8. researchgate.net researchgate.net/publication/317909017_Three-dimensional_printed_upper-limb_prostheses_lack_randomised_controlled_trials_A_systematic_review

(PDF) Three-dimensional printed upper-limb prostheses ... Initial studies suggest that three-dimensional printing shows promise for customising low-cost upper-limb prosthetics. However, the efficacy and effectiveness ...