UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018105 |
|---|---|
| Receipt number | R000020953 |
| Scientific Title | Percutaneous fixation with bone grafting through the distal screw insertion hole for the treatment of scaphoid nonunion |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2020/03/27 10:30:52 |
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Basic information
Public title
Percutaneous fixation with bone grafting through the distal screw insertion hole for the treatment of scaphoid nonunion
Acronym
Percutaneous surgery for the treatment of scaphoid nonuinon
Scientific Title
Percutaneous fixation with bone grafting through the distal screw insertion hole for the treatment of scaphoid nonunion
Scientific Title:Acronym
Percutaneous surgery for the treatment of scaphoid nonuinon
Region
| Japan |
Condition
Condition
Scaphoid nonunion
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effects of percutaneous fixation with bone grafting through the distal screw insertion hole
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The period of bone union assesed by CT examination
Key secondary outcomes
1) Functional outcomes assessed with quick Disability of the Arm, Shoulder, and Hand(DASH) and Mayo wrist score
2) The period of bone union assessed by
radiographic examination
3) Functional outcomes assessed with the Visual Analog Scale (VAS) for pain
4) Functional outcomes assessed with the grip strength improvement at pre-operation,3 months, 1 and 2 year after surgey
5) Functional outcomes assessed with the Range of motion of the wrist improvement at pre-operation, 3 months, 1 and 2 year after surgery
6) The assessment of radiographical changes at pre-operation and final follow-up(scapho-lunate angle and radio-lunate angle)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The percutaneous fixation with bone grafting through the screw insertion hole
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Scaphoid nonunion
2)Substantial bone loss within the nonunion site
Key exclusion criteria
1) Large sclerosis area of the scaphoid nonunion
2) Poor vascularity of the proximal fragmentof the scaphoid
3) No osteoarthritis changes in surrounding wrist joint
4) The patient who is unable to comply with this study protocol
5) The patient who is unable to comply with the consent form of this study
6) The patient who was recognized unsuitable for this study by primary physician
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Souichi |
| Middle name | |
| Last name | Ohta |
Organization
Kyoto University
Division name
Department of Orthopaedic Surgery
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL
075-751-3367
sota@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Souichi |
| Middle name | |
| Last name | Ohta |
Organization
Kyoto University
Division name
Department of Orthopaedic Surgery
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
TEL
075-751-3367
Homepage URL
seikei@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committe, Kyoto University Hospital
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto City
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部付属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020953
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/06/27 | 太田壮一 実施計画書150423.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
