UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017124
Receipt number R000019862
Scientific Title JOURNEY II BCS Multi Centre Study in Japan
Date of disclosure of the study information 2015/05/17
Last modified on 2021/07/08 11:47:43

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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 or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



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

2021 Year 07 Month 08 Day



Link to view the page

Value
https://center6.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