UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The exploratory clinical study relates to the promoting effect and the safety of carbon dioxide transdermal absorption on the rehabilitation after total knee arthroplasty.
Title of the study (Brief 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.
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	Tomoyuki Matsumoto
Organization	Kobe University Hospital
Division name	Department of Orthopaedic Surgery
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo
TEL	078-382-5985
Email	matsun@m4.dion.ne.jp

Public contact
Name of contact person	Koji Takayama
Organization	Kobe University Hospital
Division name	Department of Orthopaedic Surgery
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, Hyogo
TEL	078-382-5985
Homepage URL
Email	kojitakayama1978@gmail.com

Sponsor
Institute	Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021621