Distal Radioulnar Joint SprainNCT03658096
Quantitative Assessment of Distal Radioulnar Joint Stability With Pressure-Monitor Ultrasonography
A study testing pressure monitor ultrasound system in people with Distal Radioulnar Joint Sprain and Triangular Fibrocartilage Complex Injury, run by Tokyo Medical University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radioulnar Joint Sprain, Triangular Fibrocartilage Complex Injury
- What is being tested?
- pressure monitor ultrasound system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 1 Sep 2017to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
- DRUJ instability patients
Who cannot join
- the participants who had a history of previous wrist trauma and wrist pain will be excluded
Trial locations and contacts
1 site in 1 country.
Japan1 site
Tokyo Medical University Ibaraki Medical Center
Ami, Ibaraki, 300-0395
About this study
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.
- Being tested
- pressure monitor ultrasound system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure monitor ultrasound systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Active comparator | Not described Receives: Device: pressure monitor ultrasound system |
| DRUJ instability patients | Active comparator | Not described Receives: Device: pressure monitor ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Sep 2017
- Primary completion27 Aug 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radioulnar Joint SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- patients and healthy controls
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuichi Yoshii, Tokyo Medical University
- Investigators
- Tomoo Ishii, Study director, Tokyo Medical University Ibaraki Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658096
- Sponsor's protocol ID
- 17-26
- Status last verified
- Apr 2022
- First submitted
- 27 Aug 2018
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Distal Radioulnar Joint Stability With Pressure-Monitor Ultrasonography
- ClinicalTrials.gov ID
- NCT03658096
- Acronym / sponsor ID
- 17-26
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tokyo Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 27 Aug 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- patients and healthy controls
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Active comparator | Device: pressure monitor ultrasound system |
| DRUJ instability patients | Active comparator | Device: pressure monitor ultrasound system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy volunteers
- DRUJ instability patients
Key exclusion criteria (1 listed)
- the participants who had a history of previous wrist trauma and wrist pain will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pressure monitor ultrasound systemPatients 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. | Device | DRUJ instability patients, Healthy volunteer |
Primary outcome
Instability of distal radioulnar joint (pressure)
Time frame: 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)
Time frame: 1 year
According to the measurements of the displacement of distal radioulnar joint, determine if the exam can distinguish patients from healthy subjects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomoo Ishii study director
Tokyo Medical University Ibaraki Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pressure monitor ultrasound system in people with Distal Radioulnar Joint Sprain and Triangular Fibrocartilage Complex Injury, run by Tokyo Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instability of distal radioulnar joint (pressure) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.