UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043163 |
|---|---|
| Receipt number | R000049268 |
| Scientific Title | Comparative study on braces for thumb carpometacarpal osteoarthritis |
| Date of disclosure of the study information | 2021/02/09 |
| Last modified on | 2024/02/01 09:09:25 |
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Basic information
Public title
Comparative study on braces for thumb carpometacarpal osteoarthritis
Acronym
Study on braces for thumb CMC arthritis
Scientific Title
Comparative study on braces for thumb carpometacarpal osteoarthritis
Scientific Title:Acronym
Study on braces for thumb CMC arthritis
Region
| Japan |
Condition
Condition
thumb carpometacarpal osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness of two different braces for the thumb designed to facilitate long-time wear.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain evaluated by Visual Analogue Scale from pre-treatment to 24 weeks
Key secondary outcomes
Grip strength, pinch strength, range of motion, Patient-oriented functional evaluation using QuickDASH, X-ray findings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Patients treated by standard brace will be evaluated in 8, 12, and 24 weeks.
Interventions/Control_2
Patients treated by brace with support pillar will be evaluated in 8, 12, and 24 weeks.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pain in the thumb carpometacarpal joint with consent to this study.
Key exclusion criteria
Patients with inflammatory arthritis including rheumatoid arthritis.
Patients treated by steroid injection in the joint.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Miura |
Organization
JR Tokyo General Hospital
Division name
Orthopaedic Surgery
Zip code
151-8528
Address
2-1-3, Yoyogi, Shibuya-ku,Tokyo, Japan
TEL
03-3320-2210
miuratoshiki@gmail.com
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Miura |
Organization
JR Tokyo General Hospital
Division name
Orthopaedic Surgery
Zip code
151-8528
Address
2-1-3, Yoyogi, Shibuya-ku,Tokyo, Japan
TEL
03-3320-2210
Homepage URL
miuratoshiki@gmail.com
Sponsor or person
Institute
JR Tokyo General Hospital
Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
ALCARE Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JR Tokyo General Hospital
Address
2-1-3, Yoyogi, Shibuya-ku,Tokyo, Japan
Tel
03-3320-2210
06share09@jreast.co.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
| 2021 | Year | 02 | Month | 09 | 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
30
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under statistical analysis
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049268
