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

NCT03658096 | Unknown

• 1 other identifier: 17-26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radioulnar Joint Sprain; Triangular Fibrocartilage Complex Injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Healthy volunteer

ACTIVE COMPARATOR

Device: pressure monitor ultrasound system

DRUJ instability patients

ACTIVE COMPARATOR

Device: pressure monitor ultrasound system

Interventions

pressure monitor ultrasound system 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; Healthy volunteer

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers
• DRUJ instability patients

You may not qualify if:

• the participants who had a history of previous wrist trauma and wrist pain will be excluded

Sponsors & Collaborators

• Tokyo Medical University: lead

Study Sites (1)

Tokyo Medical University Ibaraki Medical Center

Ami, Ibaraki, 300-0395, Japan

Location

Study Officials

• Tomoo Ishii

  Tokyo Medical University Ibaraki Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Orthopaedic Surgery

Model Details: patients and healthy controls

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 5, 2018
• Study Start: September 1, 2017
• Primary Completion: August 27, 2024
• Study Completion: March 30, 2025
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)