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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005334
Receipt No. R000006340
Scientific Title The Outcome of the NexGen CR-Flex Mobile Bearing Knee Prosthesis:A multi centre non comparative prospective study
Date of disclosure of the study information 2011/03/28
Last modified on 2014/03/25

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Basic information
Public title The Outcome of the NexGen CR-Flex Mobile Bearing Knee Prosthesis:A multi centre non comparative prospective study
Acronym NexGen CR-Flex Mobile Clinical Study
Scientific Title The Outcome of the NexGen CR-Flex Mobile Bearing Knee Prosthesis:A multi centre non comparative prospective study
Scientific Title:Acronym NexGen CR-Flex Mobile Clinical Study
Region
Japan Europe

Condition
Condition Severe knee pain and disability
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical (functional and patient assessed) and radiographic outcome of the NexGen CR-Flex Mobile Bearing Knee.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Clinical outcomes evaluated by the Knee Society assessment scoring system
Key secondary outcomes -The functional outcome evaluated by the Knee Society functional scoring system
-Radiographic outcome evaluated by anterial -posterial and medial-lateral radiographs
-Patient's general health status assessment using the Euro-Qol-5D scoring system (EQ-5D)
-The survivorship meaning that the prosthesis has not been explanted, nor is a revision planned or pending

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
80 years-old >=
Gender Male and Female
Key inclusion criteria -Patients which are indicated for total knee replacement surgery suffering from severe knee pain and disability due to degenerative joint disease including the following: osteoarthritis (OA), primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle or pseudo gout, posttraumatic arthritis and varus, valgus, or flexion deformities.
-Patient is in stable health and able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
-Patient is willing and able to cooperate in follow-up program.
-Patient or patient's legal representative has signed a Patient Informed Consent Form.
Key exclusion criteria -Patient is skeletally immature.
-Patient known to be pregnant.
-Varus/valgus deformity with mechanical axis >20 degrees.
-Fixed flexion deformity >15 degrees.
-Patients with grossly insufficient femoral or tibial bone stock, e.g., due to osteoporosis, metabolic bone disease, congenital anomaly, or previous surgery to the index joint that could affect outcome.
-Patients with previously failed knee endoprosthesis of any kind.
-Patients with a previous history of infection in the affected joint.
-Patient is unwilling or unable to cooperate in a follow-up program.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuichi Gejo
Organization University of Toyama
Division name Department of Orthopaedic Surgery, Faculty of Medicine
Zip code
Address 2630 Sugitani Toyama-City Toyama, Japan
TEL 076-434-7353
Email rgejo@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Kashima
Organization Zimmer K.K.
Division name Clinical Affairs
Zip code
Address 7F, Kamiyacho Prime Place, 1-17, Toranomon 4-chome, Minato-ku, Tokyo, Japan
TEL 03-6402-6610
Homepage URL
Email akira.kashima@zimmer.com

Sponsor
Institute Zimmer K.K.
Institute
Department

Funding Source
Organization Zimmer K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 富山大学附属病院(富山県)、社会医療法人愛仁会 高槻病院(大阪府)、カッセル整形外科クリニック(ドイツ)、コヴェントリー・ウォリックシャ-病院 NHSトラスト(イギリス)、ナンシー中央病院(フランス)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 28 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
2009 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multi-center, Prospective, Uncontrolled Clinical Study

Management information
Registered date
2011 Year 03 Month 28 Day
Last modified on
2014 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006340

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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