UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019069 |
|---|---|
| Receipt number | R000021621 |
| Scientific Title | The exploratory clinical study relates to the promoting effect and the safety of carbon dioxide transdermal absorption on the rehabilitation after total knee arthroplasty. |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2017/12/14 11:56:24 |
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Basic information
Public title
The exploratory clinical study relates to the promoting effect and the safety of carbon dioxide transdermal absorption on the rehabilitation after total knee arthroplasty.
Acronym
The exploratory clinical study relates to the promoting effect and the safety of carbon dioxide transdermal absorption on the rehabilitation after total knee arthroplasty.
Scientific Title
The exploratory clinical study relates to the promoting effect and the safety of carbon dioxide transdermal absorption on the rehabilitation after total knee arthroplasty.
Scientific Title:Acronym
The exploratory clinical study relates to the promoting effect and the safety of carbon dioxide transdermal absorption on the rehabilitation after total knee arthroplasty.
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of carbon dioxide transdermal absorption on pain control after total knee arthroplasty.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analog scale for pain 16 days after surgery
Key secondary outcomes
Knee range of motion 16 days after surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcutaneous application of carbon dioxide
5 days between 7 and 14 days after surgery.
Once a day for 20 minutes
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients received total knee arthroplasty in our hospital
Key exclusion criteria
active infection
skin disease
chronic obstructive pulmonary disease
Deep vein thrombosis
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Matsumoto |
Organization
Kobe University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo
TEL
078-382-5985
matsun@m4.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Takayama |
Organization
Kobe University Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo
TEL
078-382-5985
Homepage URL
kojitakayama1978@gmail.com
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
神戸大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 01 | 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
| 2016 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021621
