UMIN-CTR Clinical Trial

Public title

Development of Algorithm for Diagnosis and Treatment of Periprosthetic Joint Infection (PJI) by Using Artificial Intelligence (AI)

Acronym

Development of Algorithm for PJI by Using AI

Scientific Title

Development of Algorithm for Diagnosis and Treatment of Periprosthetic Joint Infection (PJI) by Using Artificial Intelligence (AI)

Scientific Title:Acronym

Development of Algorithm for PJI by Using AI

Region

Japan

Condition

Periprosthetic Joint Infection

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Establish faster diagnosis and more appropriate treatments for Periprosthetic Joint Infection (PJI) by using Artificial Intelligence (AI) in order to improve patients' quality of life (QOL).

Basic objectives2

Others

Basic objectives -Others

Develop an algorithm for refinement of diagnosis & treatment of Periprosthetic Joint Infection (PJI), such as early & confirmed diagnosis, cause analysis, acuteness of symptom, etc.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Apply machine learning to analyze the statistics by using the following data:
1) Clinical findings and clinical test results of pre- and post-operative 3, 6 and 12 months;
2) Pre- and intra-operative stage of periarthritis determined by the results of clinical findings, synovial fluid test, histopathologic examination and operative data;
3) Post-operative data;
4) Pre- and post- operative Imaging test results.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet the following criterions 1) and 2):
1) irrespective of age or gender;
2) underwent either (A) or (B) at Yokohama City University Hospital during the period between January 2007 and September 2016:
(A) underwent total arthroplasty (hip or knee) or debridement with implant retaining for the case of suspected aseptic loosening or PJI;
(B) underwent total arthroplasty for the first time and neither aseptic loosening nor PJI was suspected.

Key exclusion criteria

Exclude patients who fall into any of the following conditions:
1) patients with sepsis and septic shock that could become life-threatening;
2) patients who are disqualified as sample for this research by principal and co-investigator.

Target sample size

160

Name of lead principal investigator

1st name	1) Yutaka, 2) Eiryo
Middle name
Last name	1) Inaba, 2) Kawakami

Organization

1) Yokohama City University Hospital
2) RIKEN

Division name

1) Department of Orthopaedic Surgery, 2) Medical Sciences Innovation Hub Program, MIH

Zip code

1) 236-0004, 2) 230-0045

Address

1) 3-9 Fukuura, Kanazawa-ku, Yokohama City, Kanagawa, 236-0004, Japan; 2) 1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama City, Kanagawa, 230-0045, Japan

TEL

045-787-2800

Email

yute0131@med.yokohama-cu.ac.jp

Name of contact person

1st name	Yutaka
Middle name
Last name	Inaba

Organization

Yokohama City University Hospital

Division name

Department of Orthopaedic Surgery

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, Kanagawa, 236-0004, Japan

TEL

045-787-2800

Homepage URL

Email

yute0131@med.yokohama-cu.ac.jp

Institute

Department of Orthopaedic Surgery, Yokohama City University Hospital

Institute

Department

Personal name

Organization

Yokohama Life Innovation Platform, (LIP. Yokohama)

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Japan

Co-sponsor

RIKEN

Name of secondary funder(s)

Organization

Clinical Research Coordination Department, Center for Novel and Exploratory Clinical Trials

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

Tel

+81-45-787-2714

Email

rinri@yokohama-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属病院（神奈川県）、
理化学研究所（神奈川県）

Date of disclosure of the study information

2017

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

144

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

10

Month

05

Day

Date of IRB

2017

Year

11

Month

02

Day

Anticipated trial start date

2017

Year

12

Month

01

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center retrospective cohort study. Patients who underwent either total arthroplasty (hip or knee) or debridement with implant retaining at Yokohama City University Hospital during the period between January 2007 and September 2016 are the subjects of this study. Since it is a retrospective study and no subjects being recruited, the informed consent has been waived by the IRB. Instead, we will release the description of this study by either posting at the posting area of Yokohama City University Hospital or announcing on the hospital's website in order to guarantee the subject's right to opt out.

Registered date

2017

Year

11

Month

30

Day

Last modified on

2023

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034364