UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029689
Receipt No. 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 2017/10/17

* 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 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
Email 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
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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 24 Day
Last follow-up date
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
2017 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033812

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.