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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030180
Receipt No. R000034364
Scientific Title Development of Algorithm for Diagnosis and Treatment of Periprosthetic Joint Infection (PJI) by Using Artificial Intelligence (AI)
Date of disclosure of the study information 2017/12/01
Last modified on 2019/07/01

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Basic information
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
Condition Periprosthetic Joint Infection
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

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 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

Research contact person
Name of lead principal investigator
1st name 1) Naomi, 2) Eiryo
Middle name
Last name 1) Kobayashi, 2) Kawakami
Organization 1) Yokohama City University Medical Center
2) RIKEN
Division name 1) Department of Orthopaedic Surgery, 2) Medical Sciences Innovation Hub Program, MIH
Zip code 1) 232-0024, 2) 230-0045
Address 1) 4-57 Urafune-cho, Minami-ku, Yokohama City, Kanagawa, 236-0004, Japan; 2) 1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama City, Kanagawa, 230-0045, Japan
TEL 045-261-5656
Email naomik58@aol.com

Public contact
Name of contact person
1st name Naomi
Middle name
Last name Kobayashi
Organization Yokohama City University Medical Center
Division name Department of Orthopaedic Surgery
Zip code 232-0024
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, Kanagawa, 236-0004, Japan
TEL 045-261-5656
Homepage URL
Email naomik58@aol.com

Sponsor
Institute Department of Orthopaedic Surgery, Yokohama City University Hospital
Institute
Department

Funding Source
Organization Yokohama Life Innovation Platform, (LIP. Yokohama)
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor RIKEN
Name of secondary funder(s)

IRB Contact (For public release)
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 nextjim1@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 横浜市立大学附属病院(神奈川県)、
理化学研究所(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 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 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

Progress
Recruitment status No longer recruiting
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
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
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.

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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