Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05903391
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-06-05
Brief Title:
Splint Users Satisfaction and Functional Status With Custom Finger Splints
Sponsor:
NorthShore University HealthSystem
Organization:
NorthShore University HealthSystem
Study Overview
Official Title:
Splint Users Satisfaction and Functional Status With Custom Finger Splints A Feasibility and Comparison Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users experiences with customizable 3D-printed finger splints compared to conventionally made splints Fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group customizable 3D-printed finger splint or a control group conventional thermoplastic finger splint Participants will wear assigned splint for 1 month Functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete The findings will contribute to evidence that customizable 3D-printed finger splints can serve as a feasible cost-effective option to improve patient satisfaction and functional status It will further justify the need for the application of 3D-printing in a clinical setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None