UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042344 |
|---|---|
| Receipt number | R000048340 |
| Scientific Title | Prospective observational study of implant arthroplasty for Bouchard's node |
| Date of disclosure of the study information | 2020/11/04 |
| Last modified on | 2021/05/06 09:18:45 |
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Basic information
Public title
Prospective observational study of implant arthroplasty for Bouchard's node
Acronym
Implant arthroplasty for Bouchard's node
Scientific Title
Prospective observational study of implant arthroplasty for Bouchard's node
Scientific Title:Acronym
Implant arthroplasty for Bouchard's node
Region
| Japan |
Condition
Condition
Bouchard's node
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate outcomes after implant arthroplasty for PIP osteoarthritis omong various type of implant and approached.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
patient-rated outcomes measure Hand10 at 2 years postoperatively
Key secondary outcomes
EQ-5D, PIP joint range of motion, satisfactory, direct cost, complication
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
PIP osteoarthritis
Key exclusion criteria
Have had the same finger PIP joint implant surgery in the past
May become pregnant during or during pregnancy
Participating in other clinical trials and clinical trials
Difficult to agree on documents in Japanese
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Michiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Nagoya University
Division name
Department of Hand Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
0527442957
michi-ya@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Nagoya University
Division name
Department of Hand Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
0527442957
Homepage URL
michi-ya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
81:JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
0527412111
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After IRB approval this study will start.
Management information
Registered date
| 2020 | Year | 11 | Month | 04 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048340
