UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of postoperative compression dressing avoiding patella on the swelling after total knee arthroplasty: a randomized controlled trial
Title of the study (Brief title)	Impact of postoperative compression dressing avoiding patella on the swelling after total knee arthroplasty: a randomized controlled trial
Region	Japan

Condition
Condition	Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis
Classification by specialty	Orthopedics Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the impact of the compression dressing avoiding patella on swelling around the knee following total knee arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Circumference of the thigh measured at postoperative day 1 and 7.
Key secondary outcomes	Complications.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Compression dressing using polyethylene foam having a hole at the patella.
Interventions/Control_2	Compression dressing using gauze.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled for total knee arthroplasty.
Key exclusion criteria	Patients declined to participate.
Target sample size	40

Research contact person
Name of lead principal investigator	Satomi Kayamori
Organization	Nekoyama Miyao Hospital
Division name	Division of Nursing
Address	14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
TEL	+81252822323
Email	ope@nekoyama.or.jp

Public contact
Name of contact person	Sachiyuki Tsukada
Organization	Nekoyama Miyao Hospital
Division name	Department of Orthopaedic Surgery
Address	14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
TEL	+81252822323
Homepage URL
Email	s8058@nms.ac.jp

Sponsor
Institute	Nekoyama Miyao Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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	2015 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 07 Day
Anticipated trial start date	2015 Year 09 Month 28 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	Published
URL releasing results	http://www.arthroplastytoday.org/article/S2352-3441(16)30013-9/abstract
Results
Other related information

Management information
Registered date	2015 Year 09 Month 08 Day
Last modified on	2016 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021906