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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034044
Receipt No. R000038421
Scientific Title A Prospective, Multicenter, Study to Evaluate the Safety and Effectiveness of the JOURNEY II XR Total Knee System with VERILAST Technology
Date of disclosure of the study information 2018/11/01
Last modified on 2019/03/06

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Basic information
Public title A Prospective, Multicenter, Study to Evaluate the Safety and Effectiveness of the JOURNEY II XR Total Knee System with VERILAST Technology
Acronym JOURNEY II XR with VERILAST in Japan
Scientific Title A Prospective, Multicenter, Study to Evaluate the Safety and Effectiveness of the JOURNEY II XR Total Knee System with VERILAST Technology
Scientific Title:Acronym JOURNEY II XR with VERILAST in Japan
Region
Japan

Condition
Condition The subject components are indicated for total knee arthroplasty performed for rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, or failed unicompartmental replacement.
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to provide short-term safety and performance data on the JOURNEY II XR Total Knee System.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary objective of this study is to demonstrate the safety and performance of the JOURNEY II XR by evaluating implant survival rates.
Key secondary outcomes The EuroQol Five Dimensions Questionnaire (EQ-5D-5L)
The Forgotten Joint Score-Knee (FJS-12)
The Knee injury and Osteoarthritis Outcome Scores (KOOS)
Radiographic outcomes
Range of Motion (RoM)
Adverse Events (AEs)

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
2. have all cruciate and collateral ligaments intact in the index joint
3. be an adult patient that in the judgement of the Investigator is skeletally mature
4. be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
5. consent to participate in the study by signing the IRB/EC approved informed consent form
6.
Key exclusion criteria 1. have any of the following conditions in the index joint:
a. Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
b. Significant varus or valgus deformities (>15 angle)
c. Incomplete or insufficient tissue surrounding the knee
d. Collateral ligament insufficiency
e. Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems
f. History of prior TKA
2. have any of the following conditions in the contralateral joint:
a. a previous TKA as a revision for a failed total or unicondylar knee arthroplasty
b. a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator
3. have any of the following conditions of the hip:
a. a previous contralateral or ipsilateral revision hip arthroplasty
b. ipsilateral hip arthritis resulting in flexion contracture
c. previously received an ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty that is not fully healed and well-functioning as determined by the Investigator
4. have a diagnosis of an immunosuppressive disorder
5. have an active infection, treated or untreated, systemic or at the site of the planned surgery
6. have conditions that may interfere with the TKA survival or outcome, including but not limited to: Paget's disease, Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, renal insufficiency or neuromuscular disease
7. have a BMI > 40
8. be facing current or impending incarceration
9. have a known allergy to study device or one or more of its components
10. have, in the opinion of the Investigator, an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
Target sample size 112

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Nishiike
Organization Kushiro Sanjikai Hospital
Division name Orthopaedic Surgery
Zip code
Address 4-30, Nusamai-cho, Kushiro city, Hokkaido
TEL 0154-41-2299
Email n.osamu@sanjikai.net

Public contact
Name of contact person
1st name
Middle name
Last name Mie KUWABA
Organization Smith & Nephew KK
Division name Clinical, Scientific & Medical Affairs
Zip code
Address Shiba Park Bldg.A-3F, 2-4-1, Shiba-Koen, Minato-ku, Tokyo
TEL 03-5403-8683
Homepage URL
Email mie.kuwaba@smith-nephew.com

Sponsor
Institute Smith & Nephew KK
Institute
Department

Funding Source
Organization Smith & Nephew KK
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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective, Multicenter, Post-market Clinical Follow-Up, Single-Arm Study
Effectiveness information, subject satisfaction, and quality of life will be measured.

Management information
Registered date
2018 Year 09 Month 05 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038421

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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