UMIN-CTR Clinical Trial

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
Email	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
Email	michi-ya@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048340