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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033434
Receipt No. R000038123
Scientific Title Discussion about the pulley function of the hook of hamate and positional relation between the hook of hamate and flexor tendon using ultrasound images. (intervention study)
Date of disclosure of the study information 2018/07/18
Last modified on 2018/07/18

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Basic information
Public title Discussion about the pulley function of the hook of hamate and positional relation between the hook of hamate and flexor tendon using ultrasound images. (intervention study)
Acronym Discussion about the pulley function of the hook of hamate and positional relation between the hook of hamate and flexor tendon using ultrasound images.
Scientific Title Discussion about the pulley function of the hook of hamate and positional relation between the hook of hamate and flexor tendon using ultrasound images. (intervention study)
Scientific Title:Acronym Discussion about the pulley function of the hook of hamate and positional relation between the hook of hamate and flexor tendon using ultrasound images.
Region
Japan

Condition
Condition The patients who visit our hospital and suspected of the injury of the hook of hamate, and the healthy volunteers aged 20 years or older (public postings on the homepage).
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The fracture of the hook of the hamate is relatively rare among carpal fractures and is likely to be overlooked. The treatment methods include conservative treatment, excision, and osteosynthesis, with no consistent standard.But excision is frequently selected for injuries caused by sports, such as baseball and golf, aiming at early return to competition.A high rate of nonunion after conservative treatment of fracture of the hook of the hamate has been reported, and the incidence is high in fractures of the base due to insufficient blood flow to the hook of the hamate. When a nonunion is formed in the hook of the hamate, complications develop such as rupture of the ulnar-side finger flexor tendon, ulnar neuropathy, and subluxation of the pisiform-triquetral joint. As rupture of the ulnar-side finger flexor tendon may be induced, the hook of the hamate is suggested to function as a pulley of the ulnar-side finger flexor tendon, but this has not been anatomically demonstrated.
The aim of this study was to measure and compare the curvature radii of the little and middle finger flexor tendons on ultrasound images to examine whether the hook of the hamate functions as a pulley of the ulnar-side finger flexor tendon, to assess the height of nonunion formation injuring the ulnar-side finger flexor tendon, the positional relationship between the hook of the hamate and little finger flexor tendon was evaluated on ultrasound images.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the pulley function of the hook of the hamate, the curvature radii of the little and middle finger flexor tendons at the hook of the hamate were calculated based on the visualized flexor tendons on ultrasound images. In addition, changes in these radii with extension and flexion of the fingers were examined.
Key secondary outcomes The position of the little finger flexor tendon was determined regarding the height of the hook of the hamate as 100%.Furthermore, changes in the positions of the flexor digitorum profundus and superficialis tendons with extension and flexion of the fingers were examined.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Their hands were imaged in extension of the fingers on ultrasound images (Venue 40(GE Healthcare Japan Ltd), Noblus(Hitachi,Ltd.)).
Interventions/Control_2 Their hands were imaged flexion of the fingers onultrasound images (Venue 40(GE Healthcare Japan Ltd), Noblus(Hitachi,Ltd.).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who visit our hospital and are suspected to have a ultrasound imaged (including patients who took ultrasound in the past), and healthy volunteers aged 20 years or older (public postings on the homepage).
After receiving sufficient explanation for participation intros research, subjects who gained document consent by the free will with sufficient understanding.
Key exclusion criteria Subject who did not obtain consent and the patients who judged inappropriate as subjects.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyohito NAITO
Organization Juntendo University School of Medicine
Division name Department of Orthopaedics
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 Japan.
TEL 03-3813-3111
Email knaito@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyohito NAITO
Organization Juntendo University School of Medicine
Division name Department of Orthopaedics
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 Japan.
TEL 03-3813-3111
Homepage URL
Email knaito@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Juntendo University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 18 Day
Last modified on
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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