Unique ID issued by UMIN | UMIN000017124 |
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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 |
JOURNEY II BCS Multi Centre Study in Japan
KOOS study
JOURNEY II BCS Multi Centre Study in Japan
KOOS study
Japan |
Knee osteoarthritis
Orthopedics |
Others
NO
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.
Safety,Efficacy
KOOS-ADL
Observational
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
90
1st name | |
Middle name | |
Last name | Tokifumi Majima |
International University of Health and Welfare
Department of Orthopedic Surgery
537-3, Iguchi, Nasushiobara City, 329-2763
0287-37-2221
tkmajima@iuhw.ac.jp
1st name | |
Middle name | |
Last name | Takashi Yanagawa |
Smith & Nephew Orthopaedics KK
Clinical Operations, Research & Engineering
Shiba Park Bldg. A-3F 2-4-1, Shiba-Koen Minato-ku, Tokyo 105-0011
03-5403-8256
takashi.yanagawa@smith-nephew.com
International University of Health and Welfare
Smith & Nephew KK
Other
NO
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)、
2015 | Year | 05 | Month | 17 | Day |
Unpublished
Terminated
2015 | Year | 01 | Month | 19 | Day |
2015 | Year | 04 | Month | 17 | Day |
Prospective Cohort Study
2015 | Year | 04 | Month | 13 | Day |
2021 | Year | 07 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019862
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