UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017692 |
|---|---|
| Receipt number | R000020505 |
| Scientific Title | Peri-Articular Morphine Injection in Total Knee Arthroplasty |
| Date of disclosure of the study information | 2015/05/27 |
| Last modified on | 2017/09/26 15:32:03 |
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Basic information
Public title
Peri-Articular Morphine Injection in Total Knee Arthroplasty
Acronym
Peri-Articular Morphine Injection in Total Knee Arthroplasty
Scientific Title
Peri-Articular Morphine Injection in Total Knee Arthroplasty
Scientific Title:Acronym
Peri-Articular Morphine Injection in Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Patients performed total knee arthroplasty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess whether the addition of morphine to peri-articular knee injections improves postoperative pain, range of motion, and swelling in patients undergoing TKAs
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative pain, range of motion, swelling
Key secondary outcomes
WOMAC and adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
patients undergoing TKAs received an intraoperative peri-articular injection with added morphine
Interventions/Control_2
patients undergoing TKAs received an intraoperative peri-articular injection without added morphine.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients undergoing TKAs with the diagnosis of osteoarthritis and rheumatoid arthritis
Key exclusion criteria
patients undergoing revision TKA,
patients with surgical history in knees
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwakiri |
Organization
Shiraniwa Hospital Joint Arthroplasty Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
6-10-1 Shiraniwadai Ikoma, Nara
TEL
0743-70-0022
kenpiecekenpiece@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwakiri |
Organization
Shiraniwa Hospital Joint Arthroplasty Center
Division name
Department of Orthopaedic Surgery
Zip code
Address
6-10-1 Shiraniwadai Ikoma, Nara
TEL
0743-70-0022
Homepage URL
kenpiecekenpiece@yahoo.co.jp
Sponsor or person
Institute
Shiraniwa Hospital Joint Arthroplasty Center
Institute
Department
Personal name
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
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
白庭病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
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 | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 27 | 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 | 05 | Month | 27 | Day |
Last modified on
| 2017 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020505
