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| Name | Class |
|---|---|
| Prosfit Technologies JSC | UNKNOWN |
| Centre for Allied Health and Pharmacy Excellence (CAPE) | UNKNOWN |
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The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model.
The main question[s] it aims to answer are:
Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis.
Participants will attend 6 visits across a total duration of 11 weeks during the course of the study.
The visit schedule for the study is as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laminate socket | Active Comparator | control intervention as standard treatment for transtibial amputees requiring a lower limb prosthesis |
|
| 3d printed socket | Experimental | trial intervention for transtibial amputees requiring a lower limb prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3d printed prosthetic socket | Device | 3d printed prosthetic socket produced through multi-jet fusion (MJF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prosthesis Evaluation Questionnaire | Subscales of Utility, Appearance, Sounds and Residual Limb Health, and an individual satisfaction question | after 4 weeks of socket use |
| Socket Comfort Score | Self-reported socket comfort is rated from 0 - 10, where 0 is the most uncomfortable socket imaginable and 10 the most comfortable. | at initial socket fitting and 4 weeks post-fitting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tabitha Quake | Tan Tock Seng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
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