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

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 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


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

Value
https://center6.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