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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038805
Receipt No. R000041773
Scientific Title Japan Mako THA study
Date of disclosure of the study information 2019/12/06
Last modified on 2019/12/06

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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 Satoru
Middle name
Last name Motohashi
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 Enrolling by invitation
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
2019 Year 12 Month 06 Day


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

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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