UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002991
Receipt number R000003575
Scientific Title Clinical study of a novel artificial wrist joint(NM002)
Date of disclosure of the study information 2010/01/12
Last modified on 2016/09/01 11:17:48

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Basic information

Public title

Clinical study of a novel artificial wrist joint(NM002)

Acronym

Clinical study of a novel artificial wrist joint(NM002)

Scientific Title

Clinical study of a novel artificial wrist joint(NM002)

Scientific Title:Acronym

Clinical study of a novel artificial wrist joint(NM002)

Region

Japan


Condition

Condition

Rheumatoid arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is conducted for the patients bearing the disfunction of wrist joints caused by rheumatoid arthrites. The safety and efficacy of the test device, a novel artificial wrist joint(NM002), is evaluated for 18 months after the implantation of the device to the patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Wrist Scoring System by Figgie

Key secondary outcomes

Safety:
Adverse events
X-ray findings
Efficacy:
THE DASH the JSSH version
Visual Analogue Scale
range of motion
grip


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

Implantation of an artificial wrist joint

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)Patient bearing rheumatoid arthritis applicable to the wrist arthrodesis except for the implantation of an aritifitial wrist joint..
(2)Patient at the score of less than 50 points by Wrist Scoring System by Figgie.
(3)Patient at the grade of 4 or 5 by Larsen's score.
(4)Patient at the age of 20 years old or more.
(5)Patient who understands the contents of the informed consent form.
(6)Patient who is able to sign on the informed consent form, or if not, patient who has a substitute for the signature.

Key exclusion criteria

(1)Patient who has previously experienced the the wrist joint arthropathy.
(2)Patient who was diagnosed as neuropathic arthropathy.
(3)Patient who has an evident or a possible infection in or around the wrist joint.
(4)Patient who has a mental illness and is considered not to obey directions of the doctor.
(5)Patient who is pregnant or possibly pregnant.
(6)Patient who is considered not to receive aftercare by the directions of the doctor.
(7)Patient who is participating in an another clinical study.
(8)Patient who has been previously implanted with the test device NM002.
(9)Patient in whom the test device is not expected to be fixed firmly due to poor volume of bone, or in whom functional recovery of the wrist is not expected due to difficulty of the reconstruction of tendon.
(10)Patient who has experienced serious advers reaction(s) caused by bone cement, sach as decrease in blood pressure, shock, or pulmonary embolism.
(11)Patient who is determined to be excluded from the study due to any reason by the study doctor.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name (1) Norimasa Iwasaki (2) Makoto Kondo

Organization

(1) Hokkaido University Hospital
(2) Memorial Hospital Hokkaido Orthopedics

Division name

(1) Orthopedics (2) Orthopedics

Zip code


Address

(1) North-14, West-5, Kita-ku, Sapporo, Hokkaido, Japan (2) 5-22, Hiragishi 7-jo 13-chome, Toyohira-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5992

Email

inagepck@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fujio Inage

Organization

Hokkaido University

Division name

Center for Translational Research(Hokkaido Organization for Translational Research)

Zip code


Address

North-15 West-7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5992

Homepage URL


Email

inagepck@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital Orthopedics

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University Hospital Orthopedics

Organization

Division

Category of Funding Organization

Self funding

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

2010 Year 01 Month 12 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 30 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2013 Year 09 Month 30 Day

Date of closure to data entry

2014 Year 04 Month 30 Day

Date trial data considered complete

2014 Year 09 Month 30 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 01 Month 07 Day

Last modified on

2016 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003575


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name