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

Triangular Fibrocartilage Complex Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03658096
• Other study ID #: 17-26
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2022
• Source: Tokyo Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: March 30, 2025
• Est. primary completion date: August 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radioulnar Joint Sprain
• Triangular Fibrocartilage Complex Injury

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Japan	Tokyo Medical University Ibaraki Medical Center	Ami	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Instability of distal radioulnar joint (pressure)	According to the measurements of the pressure to distal radioulnar joint, determine if the exam can distinguish patients from healthy subjects.	1 year
Primary	Instability of distal radioulnar joint (dsiplacement)	According to the measurements of the displacement of distal radioulnar joint, determine if the exam can distinguish patients from healthy subjects.	1 year