UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Anteromedial versus anterolateral skin incision in the total knee arthroplasty: randomised controlled trial
Title of the study (Brief title)	Anteromedial versus anterolateral skin incision in the total knee arthroplasty: randomised controlled trial
Region	Japan

Condition
Condition	Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the anteromedial skin incision and the anterolateral skin incision in total knee arthroplasty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cutaneous hypesthesia (evaluated with a Semmes-Weinstein monofilament)
Key secondary outcomes	Kneeling Knee injury and osteoarthritis outcome score Pain scale evaluated with 100-mm visual analogue scale Manchester Scar Scale score Complications

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	Total knee arthroplasty using anterolateral skin incision
Interventions/Control_2	Total knee arthroplasty using anteromedial skin incision
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled for total knee arthroplasty
Key exclusion criteria	Patients having a history of surgery on the operative knee (other than knee arthroscopy) Patients having severe skin hypesthesia prior to the total knee arthroplasty
Target sample size	150

Research contact person
Name of lead principal investigator	Sachiyuki Tsukada
Organization	Hokusuikai kinen hospital
Division name	Orthopaedic surgery
Address	3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL	029-303-3003
Email	s8058@nms.ac.jp

Public contact
Name of contact person	Sachiyuki Tsukada
Organization	Hokusuikai kinen hospital
Division name	Orthopaedic surgery
Address	3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan
TEL	029-303-3003
Homepage URL
Email	s8058@nms.ac.jp

Sponsor
Institute	Hokusuikai kinen hospital
Institute
Department

Funding Source
Organization	Hokusuikai kinen hospital
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 02 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 07 Day
Anticipated trial start date	2015 Year 02 Month 11 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	https://www.arthroplastyjournal.org/article/S0883-5403(18)30561-8/fulltext
Results
Other related information

Management information
Registered date	2015 Year 02 Month 08 Day
Last modified on	2018 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019134