UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033812