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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name