UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012368 |
|---|---|
| Receipt number | R000014459 |
| Scientific Title | The multicenter randomized controlled trial on the effectiveness of the medial side single hinge knee brace with strap (Unloader One) and the double hinge knee brace with center bridge (CB brace) for varus knee osteoarthritis |
| Date of disclosure of the study information | 2013/11/21 |
| Last modified on | 2023/11/29 10:27:08 |
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Basic information
Public title
The multicenter randomized controlled trial on the effectiveness of the medial side single hinge knee brace with strap (Unloader One) and the double hinge knee brace with center bridge (CB brace) for varus knee osteoarthritis
Acronym
The multicenter randomized controlled trial on the effectiveness of the medial side single hinge knee brace (Unloader One) and the double hinge knee brace (CB brace) for varus knee osteoarthritis
Scientific Title
The multicenter randomized controlled trial on the effectiveness of the medial side single hinge knee brace with strap (Unloader One) and the double hinge knee brace with center bridge (CB brace) for varus knee osteoarthritis
Scientific Title:Acronym
The multicenter randomized controlled trial on the effectiveness of the medial side single hinge knee brace (Unloader One) and the double hinge knee brace (CB brace) for varus knee osteoarthritis
Region
| Japan |
Condition
Condition
Varus knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effectiveness of the medial side single hinge knee brace with strap (Unloader One) and the double hinge knee brace with center bridge (CB brace) for varus knee osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual Analogue Scale(VAS)(Rest/Walking)
MOS Short-Form 36-Item Health Survey (SF-36)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Key secondary outcomes
5m comfortable and maximum walking speed
Time Up and Go test
Isometric knee extension strength
Analgesic usage in the past month
The number of intra-articular injections in the past month
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
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Control(Only the use of analgesics and intra-articular injection)
Interventions/Control_2
The medial side single hinge knee brace with strap(Unloader One)
Interventions/Control_3
The double hinge knee brace with center bridge(CB brace)
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Varus knee osteoarthritis on the basis of the criteria of American College of Rheumatology (Altman et al. Arthritis Rheum. 29:1039-49.1986)
The radiographic severity according to the Kellgren-Lawrence system of Grade 2 or higher
Key exclusion criteria
Present use of a brace
An operation on the knee within the previous six months
History of arthroplasty in the knee
Arthritis other than osteoarthritis
Skin disease
Severe leg edema
Peripheral vascular disease
Varicose veins
Severe dementia
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyomi Yoshimoto |
Organization
Nara Medical University
Division name
Department of General Medicine
Zip code
Address
840 Shijo-cho, Kashihara,634-8521 Nara,JAPAN
TEL
0744-22-3051(3471)
kym@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyomi Yoshimoto |
Organization
Nara Medical University
Division name
Department of General Medicine
Zip code
Address
840 Shijo-cho, Kashihara,634-8521 Nara,JAPAN
TEL
0744-22-3051(3471)
Homepage URL
kym@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Department of General Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
ALCARE Co.
SAKIMA Prosthetics & Orthotics Co.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
十津川村国民健康保険小原診療所（奈良県）
明日香村国民健康保険診療所（奈良県）
大福診療所（奈良県）
奈良市柳生診療所（奈良県）
天川村国民健康保険診療所（奈良県）
辻村病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 21 | 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
33
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data analysis in progress.
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
| 2013 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2013 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014459
