Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648798
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
LIMBER UniLeg Rapid On-demand and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Sponsor:
None
Organization:
None
Study Overview
Official Title:
LIMBER UniLeg Rapid On-demand and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The LIMBER UniLeg a 3D printed single-piece transtibial prosthetic limb is sufficiently equivalent to traditional passive prosthetic limbs no motors or sensors while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis This is a single-site Phase I Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device 1 month and the study device 1 month
Detailed Description:
Globally 35-40 million people need prosthetics or other assistive devices and this number is expected to double by 2050 due to factors including an aging population and the rise in diabetes However only 5-15 of people in need have access to prosthetics or other assistive devices in both underserved and developed countries The result is that millions of people are denied basic quality of life because they cant walk take care of themselves or participate in society The lack of availability stems from several factors including poor access to clinics and high cost Prosthetic devices are hand-sculpted and assembled by prosthetists via complex and time-consuming processes High-cost 3rd party components are used to connect and align the hand-crafted components leading to an expensive end-product
Currently several companies are successfully delivering 3D printed prosthetic sockets but no one can deliver a fully 3D printed single piece unibody prosthesis 3D printed sockets have been shown to provide increased comfort and fit and streamline the manufacturing process but using traditional pylon anklefoot and connector components lead to many of the same issues as traditional devices Only 3D printing the socket may improve the outcome for people who could have gotten a traditional device but leaves behind the people in need who dont have access in the first place
The custom-fit requirements make it difficult to mass-produce affordable devices and a lack of access to proper health care and medical professionals prevents adjustments needed to maintain safe comfortable and reliable prosthetic devices This is critically important during the early recovery period when residual limbs change in shape due to atrophy and scar tissue formation as well as having nerve endings that may be extra- sensitive For children who grow quickly and need new devices every few months or years swift access is both physically and psychologically important Small imperfections at the prosthesis-limb interface can cause severe discomfort and may be the difference between an amputee wearing their prosthesis or choosing to forgo mobility To obtain a well-fitted socket prosthetists take measurements of the residual limb with a fitted liner and then mark anatomical areas on the limb After assessing the limb the prosthetist will use plaster bandages to create a cast around the limb The anatomical marks will transfer to the interior of the mold such that the prosthetist can attempt to design the socket to consider regions of bone or soft tissue The prosthetist can manipulate the plaster bandages while they are hardening to adjust its shape This shaping requires years of experience and will only result in a comfortable functional socket if the prosthetist is highly skilled Due to the expensive and time-consuming nature of this traditional process new solutions are urgently needed
Clinical Trial Justification
During this study the study team expects to gather both quantitative and qualitative data that will be used to produce a performance report on the functionality of the LIMBER UniLeg The goal of this trial is to provide evidence of non-inferiority of the intervention compared to the functional performance of similarly featured passive prosthetic devices eg the patients existing device
This clinical trial will quantify the functionality clinical efficacy and quality of care of the LIMBER UniLeg and compare it to traditional passive prosthetic devices referred to as existing prosthetic devices EPD This will provide evidence that LIMBERs novel 3D printing scanning and digital design workflow produces devices that are not inferior to traditionally manufactured prosthetic limbs
Currently several companies are successfully delivering 3D printed prosthetic sockets but no one can deliver a fully 3D printed single piece unibody prosthesis 3D printed sockets have been shown to provide increased comfort and fit and streamline the manufacturing process but using traditional pylon anklefoot and connector components lead to many of the same issues as traditional devices Only 3D printing the socket may improve the outcome for people who could have gotten a traditional device but leaves behind the people in need who dont have access in the first place
The custom-fit requirements make it difficult to mass-produce affordable devices and a lack of access to proper health care and medical professionals prevents adjustments needed to maintain safe comfortable and reliable prosthetic devices This is critically important during the early recovery period when residual limbs change in shape due to atrophy and scar tissue formation as well as having nerve endings that may be extra- sensitive For children who grow quickly and need new devices every few months or years swift access is both physically and psychologically important Small imperfections at the prosthesis-limb interface can cause severe discomfort and may be the difference between an amputee wearing their prosthesis or choosing to forgo mobility To obtain a well-fitted socket prosthetists take measurements of the residual limb with a fitted liner and then mark anatomical areas on the limb After assessing the limb the prosthetist will use plaster bandages to create a cast around the limb The anatomical marks will transfer to the interior of the mold such that the prosthetist can attempt to design the socket to consider regions of bone or soft tissue The prosthetist can manipulate the plaster bandages while they are hardening to adjust its shape This shaping requires years of experience and will only result in a comfortable functional socket if the prosthetist is highly skilled Due to the expensive and time-consuming nature of this traditional process new solutions are urgently needed
Clinical Trial Justification
During this study the study team expects to gather both quantitative and qualitative data that will be used to produce a performance report on the functionality of the LIMBER UniLeg The goal of this trial is to provide evidence of non-inferiority of the intervention compared to the functional performance of similarly featured passive prosthetic devices eg the patients existing device
This clinical trial will quantify the functionality clinical efficacy and quality of care of the LIMBER UniLeg and compare it to traditional passive prosthetic devices referred to as existing prosthetic devices EPD This will provide evidence that LIMBERs novel 3D printing scanning and digital design workflow produces devices that are not inferior to traditionally manufactured prosthetic limbs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None