Splint Users' Satisfaction and Functional Status With Custom Finger Splints

Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hypermobility of Interphalangeal Joints; Swan-Neck Deformity
• Intervention / Treatment: Device: 3D-Printed Finger Splints; Device: Conventional Finger Splints

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natasha Irani, OTD, BA; Phone Number: 3108 773-878-8200; Email: nirani@schosp.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60625
      • Recruiting
      • Swedish Hospital Part of NorthShore University HealthSystems
      • Contact: Natasha Irani, OTD, BA; Phone Number: 3108 773-878-8200; Email: nirani@schosp.org
    • Evanston, Illinois, United States, 60201
      • Recruiting
      • NorthShore University HealthSystem
      • Contact: Judy Blau; Email: JBlau@northshore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D-Printed Finger Splints; Participants who wear the experimental customizable 3D-printed finger splints	Device: 3D-Printed Finger Splints; The intervention is wearing a novel finger splint produced by a 3D-printer
Active Comparator: Conventional Finger Splints; Participants who wear the control, conventionally made finger splints	Device: Conventional Finger Splints; This intervention is wearing a finger splint produced by a conventional method using thermoplastic material typically used in a clinical setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month
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	1 month

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: technology; 3d-printing; finger splints; hypermobile joints
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: EH23-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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