A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation

The Researchers are trying to assess which splint limits forearm rotation the best. These splints are commonly used in hand therapy to limit forearm rotation. This data will help hand surgery and hand therapy provide better outcomes.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Hely & Weber MTC Fracture Brace; Device: Thermoplastic orthosis; Device: Delta cast orthosis

Detailed Description

Common upper extremity injuries often need to heal with no wrist and forearm range of motion. Forearm range of motion includes supination and pronation. Injuries that necessitate limiting forearm range of motion include fracture patterns involving the distal radioulnar joint (DRUJ), proximal radioulnar joint (PRUJ), triangular fibrocartilage complex (TFCC), both bone forearm fractures, ulnar shortening procedures, radial and ulnar osteotomies, DRUJ instability. Long arm orthoses, sugar tong orthoses and muenster style orthoses can all limit forearm rotation.

Past research has indicated common methods of immobilization to include the following: sugar tongs cast/orthosis, muenster cast/orthosis, long arm cast/orthosis/or short arm cast/orthosis, and an antirotation orthosis.

Currently, there are no research studies that compare the amount of forearm rotation in a traditional thermoplastic orthoses to newer materials such as a Delta Cast orthosis, or prefabricated muenster orthoses such as the Hely and Weber MTC Fracture Brace. The purpose of this study is to assess which orthosis-a traditional thermoplastic ulnar based muenster, a delta cast style muenster and the Hely and Weber MTC Fracture Brace-allows for the least amount of supination and pronation in a healthy population in the dominant extremity.

The researchers will assess the 3 different orthoses using a standard measuring device for pronation and supination. The participants will also be asked questions regarding comfort, fit, and style of each orthosis. 30 Participants data will be collected during the study.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No prior wrist or elbow injuries on the dominant side of his/her body
• Ability to complete study in one sitting of 90-120 minutes
• Between the ages of 18 years and 100 years
• Ability to follow directions and speak and read English

Exclusion Criteria:

• Prior wrist or elbow injuries on the dominant side of his/her body
• Subjects with known rheumatoid arthritis deformities of the wrist or any prior wrist surgeries are excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Individuals; Subject will be measured for forearm rotation while wearing the custom orthoses Hely & Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis.	Device: Hely & Weber MTC Fracture Brace; Prefabricated muenster orthosis; Device: Thermoplastic orthosis; Muenster orthosis fabricated out of thermoplastics and secured with Velcro; Device: Delta cast orthosis; Muenster orthosis fabricated out of Delta Cast and secured with Velcro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC	Degree of forarm rotation (supination/pronation) measured by an electronic goniometer device reported unit of measurement in degrees while wearing each of the orthoses.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Orthotics and Prosthetics User's Survey (OPUS )	The OPUS is a well validated, self-report questionnaire which consists of five modules; specifically, five questions from the OPUS: Satisfaction with Device and Services Module were used. These five questions were scored on a 5-point Likert scale from strongly agree to strongly disagree. A sixth option of "don't know" or "not applicable" was also available. Strongly agree = 5, Agree = 4, Neutral =3, Disagree =2, Strongly Disagree =1. If the participant chose don't know or not applicable that question was excluded for that participant. The five questions included-; . My orthosis fits well.; . The weight of my orthosis is manageable.; . It is easy to put on my orthosis.; . My orthosis is pain free to wear.; . My orthosis looks good. The remaining 16 questions from the module were excluded, as they did not pertain to healthy volunteers wearing the orthosis only during his/her research participation.	1 day

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Stepanie Kannas, CHT, OT, OTD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: October 13, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18-008562

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