UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043551 |
|---|---|
| Receipt number | R000049695 |
| Scientific Title | Japan Mako Knee Registry |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2023/10/02 16:45:34 |
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Basic information
Public title
Japan Mako Knee Registry
Acronym
Japan Mako Knee Registry
Scientific Title
Japan Mako Knee Registry
Scientific Title:Acronym
Japan Mako Knee Registry
Region
| Japan |
Condition
Condition
knee osteoarthritis, other
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effectiveness of knee arthroplasty with Mako system in Japanese general practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Effectiveness
Revision rate due to poor implant placement up to 2 years postoperatively
Key secondary outcomes
Effectiveness
-accuracy of Implant placement
- Improvement of postoperative knee function (patient-based outcomes such as KSS, JOA score, FJS, etc.)
- reduction of early postoperative pain (VAS score, painkillers usage)
Safety
incidence of intraoperative complications
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 is a candidate for knee arthroplasty with Mako, or patient underwent knee arthroplasty with Mako.
2) Patient has signed an Informed
Patient Consent Form*.
3) Patient expects to be evaluable for 2-years observation period postoperatively*.
*Not applicable for patients included with opt-out.
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Suzuki |
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 | Kenta |
| Middle name | |
| Last name | Suzuki |
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
Kumamoto Kinoh Hospital Clinical Research Ethics Committee
Address
8-1, Yamamuro 6-chome, Kita-ku, Kumamoto-shi, Kumamoto
Tel
096-345-8111
medlab@juryo.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
医療法人社団 我汝会 えにわ病院（北海道） 、公益財団法人 日産厚生会 玉川病院（東京）、医療法人社団 三成会 新百合ヶ丘総合病院（神奈川県）、社会医療法人 寿量会 熊本機能病院（熊本県）、社会医療法人 緑泉会 米盛病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 08 | 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
811
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 | 01 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter,Observational Study
Management information
Registered date
| 2021 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049695
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
