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Custom 3D-Printed Splints for Hyperextended Fingers
N/A
Recruiting
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if custom 3D-printed finger splints improve patient satisfaction and function better than traditional splints. 50 people with hyperextended fingers will wear either one for 1 month and be surveyed at the end.
Who is the study for?
This trial is for English-speaking adults over 18 with hyperextended finger joints, which may include swan-neck deformity. It's suitable for those who can wear a finger splint for a month, whether or not they're pregnant and regardless of previous orthosis use.
What is being tested?
The study compares user satisfaction and functional status between conventional thermoplastic finger splints and customizable 3D-printed ones. Fifty participants will be assigned to one of the two groups by researchers and will use their designated splints for one month.
What are the potential side effects?
While specific side effects are not detailed, potential issues could include discomfort from wearing the splint, skin irritation under the device, or reduced mobility in the affected finger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Modified Version of Orthotics and Prosthetics User Survey - Functional Status
Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 3D-Printed Finger SplintsExperimental Treatment1 Intervention
Participants who wear the experimental customizable 3D-printed finger splints
Group II: Conventional Finger SplintsActive Control1 Intervention
Participants who wear the control, conventionally made finger splints
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Who is running the clinical trial?
NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,592 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not fluent in English.I am unable to make my own medical decisions.My finger joints extend more than normal.I have (or have not) used a finger brace for my symptoms.I may or may not be pregnant.I am under 18 years old.I am capable of making my own health decisions.I can wear a finger brace for a month.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: 3D-Printed Finger Splints
- Group 2: Conventional Finger Splints
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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