LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
NCT ID: NCT06648798
Last Updated: 2024-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-12-20
2026-10-31
Brief Summary
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Detailed Description
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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, ankle/foot, 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 don't 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, e.g. the patient's 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 LIMBER's novel 3D printing, scanning, and digital design workflow produces devices that are not inferior to traditionally manufactured prosthetic limbs.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Intervention
Participants will be 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).
Limber Limb
Participants will be 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).
Interventions
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Limber Limb
Participants will be 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).
Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Persons, aged 18 to 75
4. In good general health as determined by clinical site monitor
5. Weight \< 125kg
6. Are not diabetic (self reported)
7. Be a unilateral transtibial amputee of more than 1 year since amputation
8. Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
9. Live in the Southern California region (within 50 miles of UCSD)
10. Has sufficient sensation in residual limb as tested by the clinical site monitor
11. Agreement to adhere to Lifestyle Considerations throughout study duration 11a. Use the testing device (EPD or UniLeg) only during the testing periods. 11b. Walk at least 14,000 steps per week (average of 1 mile per day). 11c. Maintain a similar diet and activity level throughout study duration (no abrupt changes of weight, activity, etc.)
Exclusion Criteria
2. Prosthetic device with active motors, sensors, etc.
3. Pregnancy (due to fall risk)
4. Diabetic (due to poor limb sensation), self reported
5. No under 18 (due to inability to consent)
6. No over 75 (due to fall risk)
7. Poor proprioception or sensation at the residual limb
18 Years
75 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
LIMBER Prosthetics & Orthotics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Herb Barrack, CPO
Role: PRINCIPAL_INVESTIGATOR
LIMBER Prosthetics & Orthotics Inc
Locations
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University of California San Diego
La Jolla, California, United States
Limber Prosthetics & Orthotics Inc
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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Limber Prosthetics Website
Other Identifiers
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803632
Identifier Type: -
Identifier Source: org_study_id
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