UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018825 |
|---|---|
| Receipt number | R000021775 |
| Scientific Title | Efficacy of flurbiprofen axetil as add-on therapy for postoperative pain after Total Knee Arthroplasty |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2017/02/12 11:21:30 |
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Basic information
Public title
Efficacy of flurbiprofen axetil as add-on therapy for postoperative pain after Total Knee Arthroplasty
Acronym
Efficacy of flurbiprofen axetil as add-on therapy for postoperative pain after Total Knee Arthroplasty
Scientific Title
Efficacy of flurbiprofen axetil as add-on therapy for postoperative pain after Total Knee Arthroplasty
Scientific Title:Acronym
Efficacy of flurbiprofen axetil as add-on therapy for postoperative pain after Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
postoperative pain after Total Knee Arthroplasty (TKA)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate efficacy of flurbirprofen axetil as add-on therapy for postoperative pain control after TKA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
- pain score (during rest and during exercise)
- other additional medication for postoperative pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer flurbiprofen axetil after TKA
Interventions/Control_2
Not administer flurbiprofen axetil after TKA
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patient who (is) / whose;
1) provides written informed consent.
2) over 65 year-old female
3) plans to have TKA for the first time at our hospital
4) is to be applied Vanguard RP type (BIOMET company)
5) FT(Femoral Tibial) angle is 180-190; before operation
6) HKA (Hip Knee Ankle) correction angle is less than 20;
7) Kellgren-Lawrence classification is grade 2-3
Key exclusion criteria
Patient who (is);
1) has disease that influences on the assessment of this study
2) considered difficult to perform assessment of this study by investigator.
3) has contraindications for medicine used in this study.
4) judged inappropriate for this study by investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Yamaguchi |
Organization
SOUSEIKAI Nishi-Kumamoto Hospital
Division name
Orthopedics
Zip code
Address
1012 KOGA, TOMIAI-MACHI, MINAMI-KU, KUMAMOTO 861-4157, JAPAN
TEL
096-358-1118
kouji-yamaguchi@nishikuma.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Hashimoto |
Organization
SOUSEIKAI Nishi-Kumamoto Hospital
Division name
Nursing Department
Zip code
Address
1012 KOGA, TOMIAI-MACHI, MINAMI-KU, KUMAMOTO 861-4157, JAPAN
TEL
096-358-1118
Homepage URL
nk-kansen@nishikuma.com
Sponsor or person
Institute
SOUSEIKAI Nishi-Kumamoto Hospital
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
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
医療法人相生会 にしくまもと病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | 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
Results
Efficacy of flurbiprofen axetil as add-on therapy for postoperative pain after Total Knee Arthroplasty was not observed (The 47th annual meeting of Japanese Society for Replacement Arthroplasty)
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
| 2015 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | 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
| 2015 | Year | 08 | Month | 27 | Day |
Last modified on
| 2017 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021775
