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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000026999
Date of registration:	21/04/2017
Prospective Registration:	Yes
Primary sponsor:	Niigata University Medical and Dental Hospital
Public title:	Multicenter clinical study to evaluate the wear resistance of the BIOCERAM AZUL head in total hip arthroplasty
Scientific title:	Multicenter clinical study to evaluate the wear resistance of the BIOCERAM AZUL head in total hip arthroplasty - AZUL study
Date of first enrolment:	2017/04/24
Target sample size:	50
Recruitment status:	Pending
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030956
Study type:	Observational
Study design:	Not selected Not selected
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Dai Miyasaka
Address:	1-754, Asahimachi-dori, Chuo-ku, Niigata City, Niigata prefecture Japan
Telephone:	025-227-2272
Email:	miyasakad@yahoo.co.jp
Affiliation:	Niigata University Medical and Dental Hospital Division of Orthpaedic Surgery

Name:	Dai Miyasaka
Address:	1-754, Asahimachi-dori, Chuo-ku, Niigata City, Niigata prefecture 951-8510 Japan
Telephone:	025-227-2272
Email:	miyasakad@yahoo.co.jp
Affiliation:	Niigata University Medical and Dental Hospital Division of Orthpaedic Surgery

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1)Patients whose weight is over 90kg, the weight restriction of the femoral components to be used. 2)Patients who are difficult to be followed for 5 years after THA(in cases that emergency treatments are expected during observation period such as patients recieving hemodialylsis and anticancer drug therapies, or patients will move) 3)Patients whose functions of the implanted device are difficult to evaluate due to of other organs such as heart and nervous system. 4)Patients who are evaluated to be unsuitable for subjects of this study by invetigators.

Age minimum: 20years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

hip joint disease

Intervention(s)

Primary Outcome(s)

Linear wear of polyethylene liner

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

KYOCERA Medical Corporation

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Joho@med.niigata-u.ac.jp

Niigata University Medical and Dental Hospital

025-227-2005

Joho@med.niigata-u.ac.jp

Results

Results available:
Date Posted:
Date Completed:
URL:

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