UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of a novel artificial wrist joint(NM002)
Title of the study (Brief title)	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	(1) Norimasa Iwasaki (2) Makoto Kondo
Organization	(1) Hokkaido University Hospital (2) Memorial Hospital Hokkaido Orthopedics
Division name	(1) Orthopedics (2) Orthopedics
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	Fujio Inage
Organization	Hokkaido University
Division name	Center for Translational Research(Hokkaido Organization for Translational Research)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 11 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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