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

Trial Summary

What is the purpose of this trial?

The neural basis underlying motor performance in children using a prosthesis has been severely understudied resulting in minimal empirical evidence. The use of functional near-infrared spectroscopy (fNIRS) in conjunction with customized and visually appealing 3D printed prostheses would provide the unique opportunity to quantitatively assess the influence of upper-limb prostheses in the neural activation patterns of the primary motor cortex and motor performance of children. This information would increase the investigators limited knowledge of how prosthesis usage influences the primary motor cortex of growing children and use this information to develop rehabilitation programs aimed at reducing prosthesis rejection and abandonment.

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 data supports the effectiveness of the treatment 3D Printed Upper-limb Prosthesis for upper extremity deformities?

Research shows that 3D-printed prostheses can be affordable, lightweight, and customized, making them a good fit for children, especially in developing countries. Studies also indicate that these prostheses can improve function and strength in children with upper-limb differences. ^{1 2 3 4 5}

Is 3D printing safe for making prostheses for upper limb deformities?

The research does not provide specific safety data for 3D-printed prostheses, but it highlights their affordability, customization, and potential benefits for children with upper limb differences. ^{1 3 5 6 7}

How is the 3D Printed Upper-limb Prosthesis treatment different from other treatments 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 them more affordable and accessible compared to traditional prostheses, which are often expensive and less personalized. ^{3 6 8 9 10}

Research Team

Jorge M Zuniga, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Functional changes through the usage of 3D-printed transitional prostheses in children. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Remote fitting procedures for upper limb 3d printed prostheses. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Applications of Three-Dimensional Printing in Upper Extremity Surgery: A Systematic Review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

3D-printed upper limb prostheses: a review. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional-printed upper limb prosthesis for a child with traumatic amputation of right wrist: A case report. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Advances in 3D-Printed Pediatric Prostheses for Upper Extremity Differences. [2022]

8. France pubmed.ncbi.nlm.nih.gov

The development of a low-cost three-dimensional printed shoulder, arm, and hand prostheses for children. [2022]

9. France pubmed.ncbi.nlm.nih.gov

Development of novel 3D-printed robotic prosthetic for transradial amputees. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Development of upper limb prostheses: current progress and areas for growth. [2022]