UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029689 |
|---|---|
| Receipt number | R000033812 |
| Scientific Title | The multi-center study of rotational allowance in total knee arthroplasty with Scorpio NRG |
| Date of disclosure of the study information | 2017/10/25 |
| Last modified on | 2021/10/27 11:02:58 |
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Basic information
Public title
The multi-center study of rotational allowance in total knee arthroplasty with Scorpio NRG
Acronym
NRG Multi-center study
Scientific Title
The multi-center study of rotational allowance in total knee arthroplasty with Scorpio NRG
Scientific Title:Acronym
NRG Multi-center study
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to demonstrate high rotational knee replacement implant minimize the impact of implant rotational alignment and achieve good outcome by evaluation of CT image, X-ray image and QOL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implant rotational alignment by CT image
Key secondary outcomes
Post-operative outcome (X-ray evaluation, JOA score, Knee Society Score (2011), and EQ-5D)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The subject requires a primary total knee replacement.
2.The subject is diagnosed as knee osteoarthritis.
3.The subject is over 20 year of age.
4.The subject can walk independently without caregiver. (Including the subject with a cane.)
5.The subject has signed the IRB approved, study specific informed consent form.
6.The subject is willing to participate continuously in the study.
Key exclusion criteria
1.The subject who has an infection or is at high risk of having it.
2.The subject is revision case.
3.The subject who has had tibia osteotomy.
4.The subject who is morbidly obese. (BMI is 40 or more.)
5.The subject who is pregnant or potential pregnancy.
6.The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess.
7.The subject has a systemic disease that would limit the ability to assess.
8.The subject who has taken immunosuppressive agent or steroids consecutively that would limit the ability to assess.
9.The subject who is an inappropriate for participating in the study in the judgement of the investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Yasui |
Organization
Teikyo University Hospital, Mizonokuchi
Division name
Orthopaedics
Zip code
Address
3-8-3, Mizonokuchi, Takatsu-ku, Kawasaki, Kanagawa
TEL
044-844-3333
yasuit@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Motohashi |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
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
Address
Tel
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
吉田総合病院（広島県）、坂下厚生総合病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 25 | 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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Rotation evaluation (CT image)
- Radiographic evaluation
- Functional score
- Patient's satisfaction
Management information
Registered date
| 2017 | Year | 10 | Month | 24 | 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=R000033812
| 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 |
