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
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
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
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
