UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028884
Receipt number R000033057
Scientific Title Multicenter retrospective study to investigate the usefulness of thermal-sprayed silver oxide- containing hydroxyapatite coating artificial hip joints in patient with high risk of infection.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/03/02 13:14:06

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Basic information

Public title

Multicenter retrospective study to investigate the usefulness of thermal-sprayed silver oxide- containing hydroxyapatite coating artificial hip joints in patient with high risk of infection.

Acronym

Retro AG study

Scientific Title

Multicenter retrospective study to investigate the usefulness of thermal-sprayed silver oxide- containing hydroxyapatite coating artificial hip joints in patient with high risk of infection.

Scientific Title:Acronym

Retro AG study

Region

Japan


Condition

Condition

Hip disorders including osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the usefulness of thermal-sprayed silver oxide- containing hydroxyapatite coating artificial hip joints in patient with high risk of infection and others

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

postoperative infection

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

The patients who had the thermal-sprayed silver oxide- containing hydroxyapatite coating stem from April 2016 to March 2017.

Key exclusion criteria

No Criteria

Target sample size

160


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaaki Mawatari

Organization

Saga University

Division name

Department of Orthopaedic Surgery, Faculty of Medicine

Zip code


Address

5-1-1 Nabeshima Saga city, Saga

TEL

0952-34-2343

Email

mawatam@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Kawano

Organization

Saga University

Division name

Department of Orthopaedic Surgery, Faculty of Medicine

Zip code


Address

5-1-1 Nabeshima Saga city, Saga

TEL

0952-34-2343

Homepage URL


Email

kawanos@cc.saga-u.ac.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery, Faculty of Medicine, Saga University

Institute

Department

Personal name



Funding Source

Organization

Medical Division, KYOCERA Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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



Other administrative information

Date of disclosure of the study information

2017 Year 09 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


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 07 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Complcation
Biological bone fixation


Management information

Registered date

2017 Year 08 Month 29 Day

Last modified on

2018 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033057


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name