UMIN-CTR Clinical Trial

Basic information
Public title	JOURNEY II BCS Multi Centre Study in Japan
Acronym	KOOS study
Scientific Title	JOURNEY II BCS Multi Centre Study in Japan
Scientific Title:Acronym	KOOS study
Region	Japan

Condition
Condition	Knee osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare outcomes of primary total knee replacement using Journey II BCS Knee System (Smith and Nephew, Inc.) in Japanese patients with pre-operative varus deformity of the knee and those with normal knee alignement.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	KOOS-ADL
Key secondary outcomes

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Age between 20 years and 75 years Patient belongs to Japanese ethnic group Willing and able to comply with the study Protocol Informed Consent Document (ICD) signed by patient Osteoarthritis in one or more compartments of the knee Non-surgical treatment options have failed to provide relief for symptoms Preoperative radiographic evidence of joint degeneration that cannot be treated in non-operative fashion Knee distal femoral varus deformity between 5 and 30 degrees or distal femur in 5-7 degrees of valgus (normal knee anatomy) Independent of study participation, patient is a candidate for commercially available Journey II BCS Total Knee System in accordance with approved indication
Key exclusion criteria	Patients who have an existing medical condition that would, in the opinion of the Investigator, compromise their participation and follow-up in the study No previous or active infection in the affected joint or systemic infection Chronic long acting narcotic pain medication Inflammatory polyarthritis Women who are pregnant Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator Participation in a clinical trial of another Investigational Drug or device within the past 30 days Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint A member of a protected population (e.g., prisoner, mentally incompetent); History of partial or total knee arthroplasty for the ipsilateral knee. History of partial or total hip arthroplasty
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tokifumi Majima
Organization	International University of Health and Welfare
Division name	Department of Orthopedic Surgery
Zip code
Address	537-3, Iguchi, Nasushiobara City, 329-2763
TEL	0287-37-2221
Email	tkmajima@iuhw.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Yanagawa
Organization	Smith & Nephew Orthopaedics KK
Division name	Clinical Operations, Research & Engineering
Zip code
Address	Shiba Park Bldg. A-3F 2-4-1, Shiba-Koen Minato-ku, Tokyo 105-0011
TEL	03-5403-8256
Homepage URL
Email	takashi.yanagawa@smith-nephew.com

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	Smith & Nephew KK
Organization
Division
Category of Funding Organization	Other
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	国際医療福祉大学病院（栃木県）、大阪大学医学部附属病院（大阪府）、愛媛大学附属病院（愛媛県）、九州大学病院（福岡県）、

Other administrative information
Date of disclosure of the study information	2015 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	Terminated
Date of protocol fixation	2015 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date	2015 Year 04 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective Cohort Study

Management information
Registered date	2015 Year 04 Month 13 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019862

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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