UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044588 |
|---|---|
| Receipt number | R000047165 |
| Scientific Title | Randomized controlled trial of knee brace for postoperative pain after total knee arthroplasty |
| Date of disclosure of the study information | 2021/06/18 |
| Last modified on | 2021/06/18 12:05:39 |
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Basic information
Public title
Randomized controlled trial of knee brace for postoperative pain after total knee arthroplasty
Acronym
Randomized controlled trial of knee brace for postoperative pain after total knee arthroplasty
Scientific Title
Randomized controlled trial of knee brace for postoperative pain after total knee arthroplasty
Scientific Title:Acronym
Randomized controlled trial of knee brace for postoperative pain after total knee arthroplasty
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effectiveness of knee brace for postoperative pain and function improvement (using numerical rating scale and knee patient-reported outcome) in patients underwent total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
numerical rating score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Study group: Using knee brace after surgery
Interventions/Control_2
Control group: Do not use knee brace after surgery
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients underwent total knee arthroplasty
2) Patients aged 20 years or order. Regardless of gender
3) Patients who able to answer patient-reported outcome survey
4) Patients who agree with patient's burden (20-30,000 yen) for knee brace cost
Key exclusion criteria
1) Patients who underwent brace therapy before surgery
2) Patients who cannot use anti-inflammatory drugs (non-steroidal anti-inflammatory drugs, acetaminophen) due to allergies.
3) Patients who have serious disease (liver damage, renal functional abnormalities and/or cardiac disease)
4) Patients who have mental disorders or a history of mental disorders (dementia, depression and/or schizophrenia)
5) Other patients who are determined to be unsuitable by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shu |
| Middle name | |
| Last name | Takagawa |
Organization
Yokohama city university medical center
Division name
orthopaedics
Zip code
232-0024
Address
urahune cho 4-57, minami-ku, yokohama
TEL
0452615656
takagawashu@hotmail.com
Public contact
Name of contact person
| 1st name | Shu |
| Middle name | |
| Last name | Takagawa |
Organization
yokohama city university medical center
Division name
orthopaedics
Zip code
232-0024
Address
urahune cho 4-57, minami-ku, yokohama
TEL
+819018672674
Homepage URL
takagawashu@hotmail.com
Sponsor or person
Institute
Yokohama city university medical center, orthpaedics
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city university
Address
hukuura 3-9, kanazawa-ku, yokohama
Tel
045-787-2800
ynext@yokohama-cu.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
横浜市立大学附属市民総合医療センター （神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 18 | 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
| 2021 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 18 | 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
Management information
Registered date
| 2021 | Year | 06 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047165
