UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044570
Receipt number R000050912
Scientific Title Clinical prediction rules for patients with chronic post-surgical pain after total knee arthroplasty
Date of disclosure of the study information 2021/06/16
Last modified on 2023/06/28 18:39:46

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Basic information

Public title

Clinical prediction rules for patients with chronic post-surgical pain after total knee arthroplasty

Acronym

Clinical prediction rules for patients with chronic post-surgical pain after total knee arthroplasty

Scientific Title

Clinical prediction rules for patients with chronic post-surgical pain after total knee arthroplasty

Scientific Title:Acronym

Clinical prediction rules for patients with chronic post-surgical pain after total knee arthroplasty

Region

Japan


Condition

Condition

Patients after total knee arthroplasty

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Creating clinical prediction rules for patients with residual knee pain after total knee arthroplasty.

Basic objectives2

Others

Basic objectives -Others

Reveal the accuracy of the prediction equation.

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Knee Injury and Osteoarthritis Outcome Score(KOOS) pain Minimal Clinically Important Difference Achieved/ not achieved

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients undergoing unilateral total knee arthroplasty for osteoarthritis
2) Patients who can walk independently with or without the use of assistive devices before and after total knee arthroplasty

Key exclusion criteria

1) Patients with rheumatoid arthritis
2) Patients with systemic lupus erythematosus
3) Patients with dementia
4) Patients with psychiatric disorders
5) Patients with neurological problems
6) Patients with complications after total knee arthroplasty
7) Patients after revision knee arthroplasty

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Junji
Middle name
Last name Nishimoto

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Rehabilitation

Zip code

350-8550

Address

1981 Kamoda, Kawagoeshi, Saitama

TEL

049-228-3529

Email

j_nishi@saitama-med.ac.jp


Public contact

Name of contact person

1st name Junji
Middle name
Last name Nishimoto

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Rehabilitation

Zip code

350-8550

Address

1981 Kamoda, Kawagoeshi, Saitama

TEL

049-228-3529

Homepage URL


Email

j_nishi@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical Center, Saitama Medical University
Department of Rehabilitation

Institute

Department

Personal name



Funding Source

Organization

FRANCE BED MEDICAL HOME CARE RESEARCH SUBSIDY PUBLIC INTEREST INCORPORATED FOUNDATIONS

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

1) Department of Rehabilitation, Kawagoe Clinic, Saitama Medical University
2) Department of Rehabilitation, Sakamidorii Hospital
3) Department of Rehabilitation, Midorii Orthopedics
4) Department of Rehabilitation, Hiroshima Clinic
5) Department of Rehabilitation, Kurashiki Heisei Hospital
6) Faculty of Health and Social Services, Kanagawa University of Human Services
7) Graduate school of Humanities and Social Sciences, Hiroshima University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Center for Clinical Research Support, Saitama Medical Center, Saitama Medical University

Address

1981 Kamoda, Kawagoeshi, Saitama

Tel

049-228-3902

Email

smcrinri@saitama-med.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

埼玉医科大学総合医療センター(埼玉県)、埼玉医科大学かわごえクリニック(埼玉県)、サカ緑井病院(広島県)、緑井整形外科(広島県)、廣島クリニック(広島県)、倉敷平成病院(岡山県)、神奈川県立保健福祉大学(神奈川県)、広島大学大学院(広島県)


Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 16 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

Completed

Date of protocol fixation

2021 Year 06 Month 16 Day

Date of IRB

2021 Year 05 Month 13 Day

Anticipated trial start date

2021 Year 06 Month 16 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Using the achievement or non-achievement of the Knee injury Osteoarthritis Outcome Score Minimal Clinically Important Difference at 3 months after total knee arthroplasty as the dependent variable and various factors involved in postoperative knee pain as the independent variables, we will create a clinical prediction rule for predicting postoperative knee pain using machine learning.


Management information

Registered date

2021 Year 06 Month 16 Day

Last modified on

2023 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050912


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name