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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026764
Receipt No. R000030726
Scientific Title Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty In the Japanese Patient Population
Date of disclosure of the study information 2017/04/03
Last modified on 2019/06/18

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Basic information
Public title Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty In the Japanese Patient Population
Acronym DSJ-2016-07 ATTUNE Cementless CR RP Japan
Scientific Title Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty In the Japanese Patient Population
Scientific Title:Acronym DSJ-2016-07 ATTUNE Cementless CR RP Japan
Region
Japan

Condition
Condition Osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.
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
22 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Subjects meeting all of the following specific criteria will be considered for participation in the study:
a) Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
b) Subject was diagnosed with NIDJD.
c) Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.
d) Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor.
e) Subject is currently not bedridden
f) Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.
g) Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in Japanese.
Key exclusion criteria Subjects will be excluded from participation in the study if they meet any of the following criteria:
a) The Subject is a woman who is pregnant or lactating.
b) Contralateral knee has already been enrolled in this study
c) Subject had a contralateral amputation.
d) Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
e) Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.
f) Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
g) Subject is currently involved in any personal injury litigation, medical-legal or Worker's Accident Insurance claims (similar to Workers Compensation in USA).
h) Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
i) Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
j) Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
k) Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
l) Subject has a medical condition with less than two (2) years life expectancy.
m) Uncontrolled gout
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sue Kemp
Organization DePuy Synthes
Division name Clinical R&D
Zip code
Address DePuy Synthes St. Anthony's Road Leeds LS11 8DT United Kingdom
TEL +4401133877800
Email skemp1@ITS.JNJ.com

Public contact
Name of contact person
1st name
Middle name
Last name Miyuki Sakamoto
Organization Johnson & Johnson K.K. Medical Company
Division name Clinical Development Clinical Operation
Zip code
Address 5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo 101-0065,Japan
TEL 03-4411-6457
Homepage URL
Email msakamo5@its.jnj.com

Sponsor
Institute Johnson & Johnson K.K. Medical Company
Institute
Department

Funding Source
Organization Johnson & Johnson K.K. Medical Company
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 神戸大学医学部附属病院(兵庫県)Kobe University Graduate School of Medicine(Hyogo)、
大阪労災病院(大阪府)Osaka Rosai Hospital(Osaka)、
名古屋市立大学病院(愛知県)Nagoya City University Hospital(Aichi)、
名古屋整形外科人工関節クリニック(愛知県)Nagoya orthopedic Clinic(Aichi)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 03 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 10 Day
Date of IRB
2017 Year 06 Month 02 Day
Anticipated trial start date
2017 Year 06 Month 30 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 29 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030726

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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