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

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Mayo Clinic

Status

Completed

Conditions

Healthy

Treatments

Device: Hely & Weber MTC Fracture Brace
Device: Thermoplastic orthosis
Device: Delta cast orthosis

Study type

Interventional

Funder types

Other

Identifiers

NCT04130425
18-008562

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Healthy Individuals
Experimental group
Description:
Subject will be measured for forearm rotation while wearing the custom orthoses Hely \& Weber MTC Fracture Brace, thermoplastic orthosis, and delta cast orthosis.
Treatment:
Device: Delta cast orthosis
Device: Thermoplastic orthosis
Device: Hely & Weber MTC Fracture Brace

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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