UMIN-CTR Clinical Trial

Basic information
Public title	The effect of hyaluronic acid injection in patient with wrist synovitis Uncontrolled exploratory clinical study
Acronym	The effect of hyaluronic acid injection in patient with wrist synovitis Uncontrolled exploratory clinical study
Scientific Title	The effect of hyaluronic acid injection in patient with wrist synovitis Uncontrolled exploratory clinical study
Scientific Title:Acronym	The effect of hyaluronic acid injection in patient with wrist synovitis Uncontrolled exploratory clinical study
Region	Japan

Condition
Condition	wrist synovitis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is designed to assess the efficacy and safety of ultrasound-guided intra-articular injection of hyaluronic acid in patients with wrist synovitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of ultrasonography findings before and after injection of hyaluronic acid (once a week during the first five weeks, and after that, every 2 or more weeks depending on their symptoms )
Key secondary outcomes	Joint findings(swelling,pain)

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	Medicine
Interventions/Control_1	ultrasound-guided intra-articular injection of hyaluronic acid in rheumatoid arthritis patients with wrist synovitis
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	1)At least 20 years old when consent is given 2)The patients who have monoarthritis/ oligoarthritis with their wrist 3)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Key exclusion criteria	1)No echo abnormal findings 2)The patients who want the other treatment such as biological therapy 3) Otherwise found ineligible as a subject by the researcher
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Hiroaki Middle name Last name Hamada
Organization	University of Miyazaki Hospital
Division name	Department of Orthopaedic Surgery
Zip code	8891692
Address	5200, Kihara Kiyotake town, Miyazaki-shi, 889-1692
TEL	0985-85-0986
Email	seikei@med.miyazaki-u.ac.jp

Public contact
1st name of contact person	1st name Hiroaki Middle name Last name Hamada
Organization	University of Miyazaki Hospital
Division name	Department of Orthopaedic Surgery
Zip code	8891692
Address	5200, Kihara Kiyotake town, Miyazaki-shi, 889-1692
TEL	0985850986
Homepage URL
Email	seikei@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki Hospital Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	University of Miyazaki Research Support Center
Address	5200, Kihara Kiyotake town, Miyazaki-shi, 889-1692
Tel	0985850986
Email	seikei@med.miyazaki-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	医療法人社団善仁会　市民の森病院（宮崎県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	8
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	2016 Year 02 Month 16 Day
Date of IRB	2016 Year 02 Month 16 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 02 Month 18 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024316