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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | UMIN000017124 |
Receipt No. | R000019862 |
Scientific Title | JOURNEY II BCS Multi Centre Study in Japan |
Date of disclosure of the study information | 2015/05/17 |
Last modified on | 2017/11/10 |
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 |
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Condition | ||
Condition | Knee osteoarthritis | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
tkmajima@iuhw.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |