UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032215 |
|---|---|
| Receipt number | R000036591 |
| Scientific Title | Discussion about the pulley function of the hook of hamate and positional relation between the hook of hamate and flexor tendon using CT scans. (intervention study) |
| Date of disclosure of the study information | 2018/04/14 |
| Last modified on | 2018/04/12 17:43:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 CT scans. (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 CT scans.
Scientific Title
Discussion about the pulley function of the hook of hamate and positional relation between the hook of hamate and flexor tendon using CT scans. (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 CT scans.
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 CT acquired using tendon conditions 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 CT scans.
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 CT. 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 CT using tendon conditions (A SOMATOM Force CT scanner (SIEMENS Healthcare K.K., Japan)
Interventions/Control_2
Their hands were imaged flexion of the fingers on CT using tendon conditions (A SOMATOM Force CT scanner (SIEMENS Healthcare K.K., Japan)
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 CT scanned (including patients who took CT scan 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
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
knaito@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
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
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 | 04 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 14 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2018 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036591
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
