UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002991
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Hokkaido University Hospital Orthopedics
Institute
Department

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
URL(English) https://upload.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


Contact us.