UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044209 |
|---|---|
| Receipt number | R000050481 |
| Scientific Title | Mako THA Screw Survey |
| Date of disclosure of the study information | 2021/05/17 |
| Last modified on | 2022/11/14 09:29:22 |
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Basic information
Public title
Mako THA Screw Survey
Acronym
Mako THA Screw Survey
Scientific Title
Mako THA Screw Survey
Scientific Title:Acronym
Mako THA Screw Survey
Region
| Japan |
Condition
Condition
hip osteoarthritis, other
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove reduction of dome screw usage by Mako system
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of screws for cup fixation
Key secondary outcomes
-Cup fixation at 3 months after the procedure
-Deviation of cup alignment between plan and post-op.
-Placement rate in Lewinnek/Callanan safe zones.
-Usage of bone augment
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) Patient underwent Total hip arthroplasty with Mako system.
2) Patient has signed an Informed
Patient Consent Form*.
3) Patient is willing to continue participating during the study observation period *.
*Not applicable for patients included with opt-out.
*Not set inclusion criteria for historical control group, who underwent THA by conventional or computer assisted surgery.
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 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
NSKclinicaltrial@stryker.com
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sumitomo Hospital Research Ethics Committee
Address
5-3-20 Nakanoshima Kita-ku, Osaka-shi, Osaka
Tel
06-6443-1261
yokota-masato@sumitomo-hp.or.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
| 2021 | Year | 05 | Month | 17 | 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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 under general medical care.
Management information
Registered date
| 2021 | Year | 05 | Month | 14 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050481
