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

Not Applicable

• Conditions: Distal Radioulnar Joint Sprain; Triangular Fibrocartilage Complex Injury
• Interventions: Device: pressure monitor ultrasound system

• Registration Number: NCT03658096
• Lead Sponsor: Tokyo Medical University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-05
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27
• Primary Completion: 2024-08-27
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	pressure monitor ultrasound system	-
DRUJ instability patients	pressure monitor ultrasound system	-

Primary Outcome Measures

Name	Time	Method
Instability of distal radioulnar joint (pressure)	1 year	According to the measurements of the pressure to distal radioulnar joint, determine if the exam can distinguish patients from healthy subjects.
Instability of distal radioulnar joint (dsiplacement)	1 year	According to the measurements of the displacement of distal radioulnar joint, determine if the exam can distinguish patients from healthy subjects.

Trial Locations

Locations (1)

Tokyo Medical University Ibaraki Medical Center; 🇯🇵 Ami, Ibaraki, Japan