UMIN-CTR Clinical Trial

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 Sue Kemp Middle name Last name Sue Kemp
Organization	DePuy Synthes
Division name	Clinical R&D
Zip code	8DT
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 Miyuki Sakamoto Middle name Last name Miyuki Sakamoto
Organization	Johnson & Johnson K.K. Medical Company
Division name	Clinical Development Clinical Operation
Zip code	101-0065
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	Kobe Univ. Hosp. clinical & Translational Research center
Address	Kobe University Hospital 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City,Hyogo Prefecture, JAPAN, 650-0017
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.jp

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	Completed
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 22 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2021 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 29 Day
Last modified on	2021 Year 10 Month 01 Day

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