3D Printed Prostheses for Upper Extremity Deformities
Palo Alto (17 mi)Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Nebraska
No Placebo Group
Approved in 1 jurisdiction
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.
Is the 3D Printed Upper-limb Prosthesis a promising treatment for upper extremity deformities?Yes, the 3D Printed Upper-limb Prosthesis is promising because it offers a low-cost solution for creating prosthetic limbs. This technology uses advanced design and printing techniques to make prostheses more affordable and accessible, especially for those who need them for daily activities.123910
What safety data exists for 3D printed prostheses for upper extremity deformities?The available research indicates that 3D printed prostheses are gaining popularity due to their affordability, customization, and accessibility, especially for children. Studies have focused on functional and strength changes in children using these prostheses, and systematic reviews have explored their clinical applications in upper extremity surgery. However, specific safety data is limited, and more research is needed to fully understand the safety and efficacy of these devices.467910
What data supports the idea that 3D Printed Prostheses for Upper Extremity Deformities is an effective treatment?The available research shows that 3D printed prostheses are effective because they are affordable, lightweight, and can be customized to fit well, especially for children who are still growing. One study highlights that these prostheses can lead to improvements in function and strength for children with upper-limb differences. Additionally, they provide a cost-effective solution for families in developing countries, making them a practical alternative to expensive custom-made prostheses.567810
Do I need to stop my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications.
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 am between 3 and 18 years old.
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.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: 3D Prostheses UsersExperimental Treatment2 Interventions
Children with unilateral congenital upper-limb reductions
Group II: Typically Developing ChildrenActive Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Nebraska at OmahaOmaha, NE
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Who is running the clinical trial?
University of NebraskaLead Sponsor
References
Development of upper limb prostheses: current progress and areas for growth. [2022]Upper extremity prosthetic technology has significantly changed in recent years. The devices available and those under development are more and more able to approximate the function of the lost limb; however, other challenges remain. This article provides a brief perspective on the most advanced upper limb prostheses available and the challenges present for continued development of the technology.
Development of novel 3D-printed robotic prosthetic for transradial amputees. [2022]Upper extremity myoelectric prostheses are expensive. The Robohand demonstrated that three-dimensional printing reduces the cost of a prosthetic extremity. The goal of this project was to develop a novel, inexpensive three-dimensional printed prosthesis to address limitations of the Robohand.
The development of a low-cost three-dimensional printed shoulder, arm, and hand prostheses for children. [2022]The prosthetic options for higher level amputees are limited and costly. Advancements in computer-aided design programs and three-dimensional printing offer the possibility of designing and manufacturing transitional prostheses at very low cost. The aim of this project was to describe an inexpensive three-dimensional printed mechanical shoulder prosthesis to assist a pre-selected subject in performing bi-manual activities.
Advances in 3D-Printed Pediatric Prostheses for Upper Extremity Differences. [2022]➤The prohibitive cost of cutting-edge prostheses prevents many children with a limb difference from obtaining them; however, new developments in 3-dimensional (3D) printing have the potential to increase the accessibility, customization, and procurement of such devices.➤Children with upper limb differences are ideal candidates for currently available 3D-printed devices because they quickly damage and outgrow prostheses, and the low cost of 3D printing makes repairs and upgrades substantially more affordable.➤Physicians and medical practitioners should become familiar with the possibilities of 3D-printed devices in order to determine the benefits and utility for their patients.
3D-printed upper limb prostheses: a review. [2018]This paper aims to provide an overview with quantitative information of existing 3D-printed upper limb prostheses. We will identify the benefits and drawbacks of 3D-printed devices to enable improvement of current devices based on the demands of prostheses users.
Functional changes through the usage of 3D-printed transitional prostheses in children. [2020]There is limited knowledge on the use of 3 D-printed transitional prostheses, as they relate to changes in function and strength. Therefore, the purpose of this study was to identify functional and strength changes after usage of 3 D-printed transitional prostheses for multiple weeks for children with upper-limb differences.
Three-dimensional-printed upper limb prosthesis for a child with traumatic amputation of right wrist: A case report. [2022]For traumatic upper limb amputees, the prohibitive cost of a custom-made prosthesis brings an insufferable financial burden for their families in developing countries. Three-dimensional (3D) printing allows for creating affordable, lightweight, customized, and well-fitting prosthesis, especially for the growing children.
Remote fitting procedures for upper limb 3d printed prostheses. [2019]The objective of the current investigation was twofold: i) describe a remote fitting procedure for upper limb 3D printed prostheses and ii) assess patient satisfaction and comfort with 3D printed prostheses fitted remotely.
Utilization of 3D printed orthoses for musculoskeletal conditions of the upper extremity: A systematic review. [2023]Systematic Review INTRODUCTION: 3D printed orthoses are emerging as a possible option in the field of hand therapy to fabricate conventional casts and orthoses. It is unknown how this technology is currently being used to treat upper extremity musculoskeletal conditions, and if 3D orthoses are comparable to custom- made low temperature thermoplastic orthoses fabricated by hand therapists.
Clinical Applications of Three-Dimensional Printing in Upper Extremity Surgery: A Systematic Review. [2023]Three-dimensional printing for medical applications in surgery of the upper extremity has gained in popularity as reflected by the increasing number of publications. This systematic review aims to provide an overview of the clinical use of 3D printing in upper extremity surgery.