UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021082 |
|---|---|
| Receipt number | R000024316 |
| Scientific Title | The effect of hyaluronic acid injection in patient with wrist synovitis Uncontrolled exploratory clinical study |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2019/03/29 14:08:15 |
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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
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
seikei@med.miyazaki-u.ac.jp
Public contact
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
seikei@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Hospital
Department of Orthopaedic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024316
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
