Quantitative Assessment of Distal Radioulnar Joint Stability With Pressure-Monitor Ultrasonography

NCT ID: NCT03658096

Last Updated: 2022-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2025-03-30

Brief Summary

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To quantitatively assess distal radio ulnar joint (DRUJ) stability, a pressure-monitor ultrasound system was developed. The objective of this study was to evaluate the force-displacement relationship of DRUJ in patients and normal subjects. Each subject will be imaged sitting with elbow flexed and forearm pronated. The dorsal surface of distal radius and the center of ulnar head will be displayed at DRUJ level. The pressure toward palmar direction will be applied to distal ulna with different levels of transducer displacements, i.e. 1 mm, 2 mm, and 3 mm. The distance between the dorsal surface of the ulnar head and the dorsal surface of the distal radius will be measured. At the same time, the pressure to the transducer will be measured.

Detailed Description

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Conditions

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Distal Radioulnar Joint Sprain Triangular Fibrocartilage Complex Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

patients and healthy controls
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy volunteer

Group Type ACTIVE_COMPARATOR

pressure monitor ultrasound system

Intervention Type DEVICE

Patients and healthy volunteers will be tested sitting with the elbow flexed and the forearm pronated. The forearm of the examinee will be secured to the table. The hand will be positioned on an adjustable block such that the forearm will be in a horizontal position. At the distal radioulnar joint level, the transducer will be maintained perpendicular to the longitudinal axis of the ulna. The dorsal surface of the distal radius and the center of the ulnar head will be displayed on a monitor.To determine the same measurement level in each volunteer, the highest aspect of the ulnar head will be taken. The DRUJ motion during cyclic loading toward the palmar direction at the distal ulna will be recorded. The compression-release cycles will be applied with the pressure-monitor ultrasound system. The cycle will be set to 1.5Hz. The pressure in the palmar direction will be applied with different levels of transducer displacements, i.e. 1 mm, 2 mm, and 3 mm.

DRUJ instability patients

Group Type ACTIVE_COMPARATOR

pressure monitor ultrasound system

Intervention Type DEVICE

Patients and healthy volunteers will be tested sitting with the elbow flexed and the forearm pronated. The forearm of the examinee will be secured to the table. The hand will be positioned on an adjustable block such that the forearm will be in a horizontal position. At the distal radioulnar joint level, the transducer will be maintained perpendicular to the longitudinal axis of the ulna. The dorsal surface of the distal radius and the center of the ulnar head will be displayed on a monitor.To determine the same measurement level in each volunteer, the highest aspect of the ulnar head will be taken. The DRUJ motion during cyclic loading toward the palmar direction at the distal ulna will be recorded. The compression-release cycles will be applied with the pressure-monitor ultrasound system. The cycle will be set to 1.5Hz. The pressure in the palmar direction will be applied with different levels of transducer displacements, i.e. 1 mm, 2 mm, and 3 mm.

Interventions

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pressure monitor ultrasound system

Patients and healthy volunteers will be tested sitting with the elbow flexed and the forearm pronated. The forearm of the examinee will be secured to the table. The hand will be positioned on an adjustable block such that the forearm will be in a horizontal position. At the distal radioulnar joint level, the transducer will be maintained perpendicular to the longitudinal axis of the ulna. The dorsal surface of the distal radius and the center of the ulnar head will be displayed on a monitor.To determine the same measurement level in each volunteer, the highest aspect of the ulnar head will be taken. The DRUJ motion during cyclic loading toward the palmar direction at the distal ulna will be recorded. The compression-release cycles will be applied with the pressure-monitor ultrasound system. The cycle will be set to 1.5Hz. The pressure in the palmar direction will be applied with different levels of transducer displacements, i.e. 1 mm, 2 mm, and 3 mm.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy volunteers
* DRUJ instability patients

Exclusion Criteria

* the participants who had a history of previous wrist trauma and wrist pain will be excluded
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tokyo Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yuichi Yoshii

Associate Professor, Department of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tomoo Ishii

Role: STUDY_DIRECTOR

Tokyo Medical University Ibaraki Medical Center

Locations

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Tokyo Medical University Ibaraki Medical Center

Ami, Ibaraki, Japan

Site Status

Countries

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Japan

Other Identifiers

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17-26

Identifier Type: -

Identifier Source: org_study_id

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