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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018825
Receipt No. 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

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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
Email 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
Email nk-kansen@nishikuma.com

Sponsor
Institute SOUSEIKAI Nishi-Kumamoto Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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