UMIN-CTR Clinical Trial

Basic information
Public title	Japan Mako THA study
Acronym	Japan Mako THA study
Scientific Title	Japan Mako THA study
Scientific Title:Acronym	Japan Mako THA study
Region	Japan

Condition
Condition	Hip osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate accuracy/precision of implant placement of Mako system in Japanese population
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. The discrepancy between pre-operative plan and post-operative implant position indicated in Mako system 2. The discrepancy between implant position indicated in Mako system and post-operative CT evaluation.
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. The patient who will receive/received THA with Mako system. 2. The patient has signed the IRB approved, study specific informed patient consent form. (Not applicable if the site allows to enroll subject retrospectively or the patient has already received THA with Mako system.) 3. The patient who is willing to participate the study during the follow-up period. (Not applicable if the site allows to enroll subject retrospectively or the patient has already received THA with Mako system.)
Key exclusion criteria	NA
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Nobuhiko Middle name Last name Sugano
Organization	Osaka University Graduate School of Medicine
Division name	Orthopedic Medical Engineering
Zip code	565-0871
Address	2-2, Yamakaoka, Suita, Osaka, Japan
TEL	06-6879-3271
Email	n-sugano@umin.net

Public contact
Name of contact person	1st name Yuko Middle name Last name Komori
Organization	Stryker Japan K.K.
Division name	Clinical Affairs
Zip code	112-0004
Address	2-6-1, Koraku, Bunkyo-ku, Tokyo
TEL	03-6894-8394
Homepage URL
Email	NSKclinicaltrial@stryker.com

Sponsor
Institute	Stryker Japan K.K.
Institute
Department

Funding Source
Organization	Stryker Japan K.K.
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	Osaka University Clinical Research Review Committee
Address	2-2, Yamadaoka, Suita City, Osaka Prefecture
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-u.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

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 06 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	2019 Year 04 Month 05 Day
Date of IRB	2019 Year 09 Month 19 Day
Anticipated trial start date	2019 Year 12 Month 05 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The evaluation will be conducted with procedure related information and x-ray/CT imaging under general medical care.

Management information
Registered date	2019 Year 12 Month 06 Day
Last modified on	2021 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041773