UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016474 |
|---|---|
| Receipt number | 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 10:47:43 |
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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
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
s8058@nms.ac.jp
Sponsor or person
Institute
Hokusuikai kinen hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019134
