UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005334
Receipt number 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 2023/10/09 13:23:48

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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 or person

Institute

Zimmer K.K.

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2009 Year 11 Month 02 Day

Date of IRB

2011 Year 01 Month 31 Day

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

2023 Year 10 Month 09 Day



Link to view the page

Value
https://center6.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