NCT04130425

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

Completed NA Results posted Last updated 1 December 2020

What this trial tests

NA trial testing Hely & Weber MTC Fracture Brace in Healthy in 30 participants. Completed in 31 January 2020.

Timeline

6 December 2019

Primary endpoint
31 January 2020

31 January 2020

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	30
Start date	6 December 2019
Primary completion	31 January 2020
Estimated completion	31 January 2020
Sites	1 location across United States

Drugs / interventions tested

• Hely & Weber MTC Fracture Brace
• Thermoplastic orthosis
• Delta cast orthosis

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Mayo Clinic

Who can join

Adults 18 to 100, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Degree of Forarm Rotation With Thermoplastic Ulnar Based Muenster Orthosis, Delta-Cast Orthosis and Hely and Weber Fracture Brace MTC Primary · 1 day

Degree of forarm rotation (supination/pronation) measured by an electronic goniometer device reported unit of measurement in degrees while wearing each of the orthoses.

Group	Value	95% CI
Thermoplastic Results	88.4	± 35.8
Delta-Cast Results	49.1	± 24.2
Hely and Weber Fracture Brace MTC	67.2	± 34.5

Orthotics and Prosthetics User's Survey (OPUS ) Secondary · 1 day

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- 1. . My orthosis fits well.

My orthosis fits well

Group	Value	95% CI
Hely & Weber MTC Fracture Brace	4.2	± 0.9
Thermoplastic Orthosis	4.0	± 0.7
Delta-Cast Orthosis	4.7	± 0.5

The weight is manageable

Group	Value	95% CI
Hely & Weber MTC Fracture Brace	4.1	± 0.9
Thermoplastic Orthosis	4.3	± 0.7
Delta-Cast Orthosis	4.4	± 0.8

Easy to put on orthosis

Group	Value	95% CI
Hely & Weber MTC Fracture Brace	3.5	± 1.2
Thermoplastic Orthosis	4.2	± 0.8
Delta-Cast Orthosis	3.8	± 1.2

My orthosis is pain free to wear

Group	Value	95% CI
Hely & Weber MTC Fracture Brace	4.2	± 0.9
Thermoplastic Orthosis	4.0	± 0.9
Delta-Cast Orthosis	4.5	± 0.9

My orthosis looks good

Group	Value	95% CI
Hely & Weber MTC Fracture Brace	3.5	± 1.2
Thermoplastic Orthosis	4.2	± 0.8
Delta-Cast Orthosis	3.4	± 1.2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.