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Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Primary Purpose

Hypermobility of Interphalangeal Joints, Swan-Neck Deformity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D-Printed Finger Splints
Conventional Finger Splints
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypermobility of Interphalangeal Joints focused on measuring 3d-printing, technology, finger splints, hypermobile joints

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Fluent in English 18 years or older Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without swan-neck deformity) Pregnant or not pregnant women Able to tolerate a finger orthosis over the course of 1 month Not decisionally impaired Have or have not previously worn a finger orthosis for symptoms Exclusion Criteria: Non-fluent in English Decisionally impaired Younger than 18 years old No proximal interphalangeal joint (PIP) joint finger hyperextension Unable to tolerate a finger orthosis over the course of 1 month

Sites / Locations

  • NorthShore University HealthSystems

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D-Printed Finger Splints

Conventional Finger Splints

Arm Description

Participants who wear the experimental customizable 3D-printed finger splints

Participants who wear the control, conventionally made finger splints

Outcomes

Primary Outcome Measures

Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device
A modified version of a Self-report questionnaire which measures participants satisfaction with assigned splint device
Modified Version of Orthotics and Prosthetics User Survey - Functional Status
A modified version of a Self-report questionnaire which measures participants' functional status during the duration of time wearing assigned finger splint device

Secondary Outcome Measures

Full Information

First Posted
June 5, 2023
Last Updated
September 25, 2023
Sponsor
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT05903391
Brief Title
Splint Users' Satisfaction and Functional Status With Custom Finger Splints
Official Title
Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypermobility of Interphalangeal Joints, Swan-Neck Deformity
Keywords
3d-printing, technology, finger splints, hypermobile joints

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D-Printed Finger Splints
Arm Type
Experimental
Arm Description
Participants who wear the experimental customizable 3D-printed finger splints
Arm Title
Conventional Finger Splints
Arm Type
Active Comparator
Arm Description
Participants who wear the control, conventionally made finger splints
Intervention Type
Device
Intervention Name(s)
3D-Printed Finger Splints
Intervention Description
The intervention is wearing a novel finger splint produced by a 3D-printer
Intervention Type
Device
Intervention Name(s)
Conventional Finger Splints
Intervention Description
This intervention is wearing a finger splint produced by a conventional method using thermoplastic material typically used in a clinical setting
Primary Outcome Measure Information:
Title
Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device
Description
A modified version of a Self-report questionnaire which measures participants satisfaction with assigned splint device
Time Frame
1 month
Title
Modified Version of Orthotics and Prosthetics User Survey - Functional Status
Description
A modified version of a Self-report questionnaire which measures participants' functional status during the duration of time wearing assigned finger splint device
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fluent in English 18 years or older Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without swan-neck deformity) Pregnant or not pregnant women Able to tolerate a finger orthosis over the course of 1 month Not decisionally impaired Have or have not previously worn a finger orthosis for symptoms Exclusion Criteria: Non-fluent in English Decisionally impaired Younger than 18 years old No proximal interphalangeal joint (PIP) joint finger hyperextension Unable to tolerate a finger orthosis over the course of 1 month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Irani, OTD, BA
Phone
773-878-8200
Ext
3108
Email
nirani@schosp.org
Facility Information:
Facility Name
NorthShore University HealthSystems
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasha Irani, OTD, BA
Phone
773-878-8200
Ext
3108
Email
nirani@schosp.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Splint Users' Satisfaction and Functional Status With Custom Finger Splints

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