UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016474
Receipt No. R000019134
Scientific Title Anteromedial versus anterolateral skin incision in the total knee arthroplasty: randomised controlled trial
Date of disclosure of the study information 2015/02/08
Last modified on 2018/06/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Anteromedial versus anterolateral skin incision in the total knee arthroplasty: randomised controlled trial
Acronym Anteromedial versus anterolateral skin incision in the total knee arthroplasty: randomised controlled trial
Scientific Title Anteromedial versus anterolateral skin incision in the total knee arthroplasty: randomised controlled trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Hokusuikai kinen hospital
Division name Orthopaedic surgery
Zip code
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
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Hokusuikai kinen hospital
Division name Orthopaedic surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.arthroplastyjournal.org/article/S0883-5403(18)30561-8/fulltext
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
2015 Year 02 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.