UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038805 |
|---|---|
| Receipt number | R000041773 |
| Scientific Title | Japan Mako THA study |
| Date of disclosure of the study information | 2019/12/06 |
| Last modified on | 2021/10/27 11:07:13 |
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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
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
NSKclinicaltrial@stryker.com
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041773
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
