UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of flurbiprofen axetil as add-on therapy for postoperative pain after Total Knee Arthroplasty
Title of the study (Brief title)	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	Koji Yamaguchi
Organization	SOUSEIKAI Nishi-Kumamoto Hospital
Division name	Orthopedics
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	Daisuke Hashimoto
Organization	SOUSEIKAI Nishi-Kumamoto Hospital
Division name	Nursing Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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)
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