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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012257
Receipt No. R000014334
Scientific Title Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial
Date of disclosure of the study information 2013/11/11
Last modified on 2016/02/05

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Basic information
Public title Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial
Acronym Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial
Scientific Title Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial
Scientific Title:Acronym Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial
Region
Japan

Condition
Condition osteoarthritis, rheumatoid arthritis, avascular necrosis of femoral condyle
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analogue Scale for postoperative pain at rest
Key secondary outcomes Visual Analogue Scale for postoperative pain during activity
Complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty
Interventions/Control_2 A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty
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 unilateral total knee arthroplasty
Key exclusion criteria Patients scheduled for bilateral simultaneous total knee arthroplasty.
Patients scheduled for unilateral total knee arthroplasty combined with implant removal.
Patients who had allergy or intolerance to one of the study drugs, regular narcotic use, renal insufficiency and prolonged QT interval on ECG.
Target sample size 74

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Nekoyama Miyao Hospital
Division name Orthopaedic Surgery
Zip code
Address 14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
TEL 025-282-2323
Email s8058@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sachiyuki Tsukada
Organization Nekoyama Miyao Hospital
Division name Orthopaedic Surgery
Zip code
Address 14-7 Konan, Chuo-ku, Niigata, Niigata, 950-1151, Japan
TEL 025-282-2323
Homepage URL
Email s8058@nms.ac.jp

Sponsor
Institute Nekoyama Miyao Hospital
Institute
Department

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)

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 猫山宮尾病院(新潟県)

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.bjj.boneandjoint.org.uk/content/98-B/2/194
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
2013 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 12 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
2013 Year 11 Month 10 Day
Last modified on
2016 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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