UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044209
Receipt No. R000050481
Scientific Title Mako THA Screw Survey
Date of disclosure of the study information 2021/05/17
Last modified on 2021/10/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
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

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
Email 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 No longer recruiting
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
2021 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050481

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.