UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029359 |
|---|---|
| Receipt number | R000033554 |
| Scientific Title | Postoperative Evaluation Using Different Tourniquet Cuff Pressure in Simultaneous Bilateral Total Knee Arthroplasty -a Double-Blind Randomised Controlled Trial- |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2020/04/09 16:39:46 |
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Basic information
Public title
Postoperative Evaluation Using Different Tourniquet Cuff Pressure in Simultaneous Bilateral Total Knee Arthroplasty -a Double-Blind Randomised Controlled Trial-
Acronym
Postoperative Evaluation Using Different Tourniquet Cuff Pressure in Simultaneous Bilateral Total Knee Arthroplasty
Scientific Title
Postoperative Evaluation Using Different Tourniquet Cuff Pressure in Simultaneous Bilateral Total Knee Arthroplasty -a Double-Blind Randomised Controlled Trial-
Scientific Title:Acronym
Postoperative Evaluation Using Different Tourniquet Cuff Pressure in Simultaneous Bilateral Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the postoperative clinical evaluation comparing randomly assigned the tourniquet pressure based on the conventional pressure and the limb occlusion pressure in simultaneous bilateral total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in thigh pain from preoperative to 24 hours postoperatively
Key secondary outcomes
Changes in thigh pain from 24 hours to 96 hours postoperatively.
Changes in knee pain from preoperative to 96 hours postoperatively.
Rate of the quality of the bloodless field and whether any technical difficulties had been encountered due to the quality of the bloodless field on a visual analog scale.
The incidence of venous thromboembolism.
Changes in knee and thigh circumference from preoperative to postoperatively.
Changes in quadriceps muscle strength from preoperative to postoperatively.
Changes in knee society score from preoperative to postoperatively.
The incidence of complications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The tourniquet cuff pressure was decided by measuring the limb occlusion pressure.
Interventions/Control_2
The conventional tourniquet cuff pressure was 300mmHg.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for simultaneous bilateral primary total knee arthroplasty.
Key exclusion criteria
A patient who can not use tourniquet,who changed the tourniquet cuff pressure during surgery,and who judged that doctor is ineligible.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Okajima |
Organization
Naniwa Ikuno Hospital
Division name
Joint Reconstruction Center
Zip code
5560014
Address
1-10-3 Daikoku Naniwa-ku Osaka-shi 556-0014
TEL
06-6632-9915
okapy915@zeus.eonet.ne.jp
Public contact
Name of contact person
| 1st name | Kenka |
| Middle name | |
| Last name | Ra |
Organization
Naniwa Ikuno Hospital
Division name
Joint Reconstruction Center
Zip code
556-0014
Address
1-10-3 Daikoku Naniwa-ku Osaka-shi 556-0014
TEL
06-6632-9915
Homepage URL
l_c_h_4160@yahoo.co.jp
Sponsor or person
Institute
Naniwa Ikuno Hospital
Joint Reconstruction 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
IRB of Naniwa Ikuno Hospital
Address
1-10-3 Daikoku Naniwa-ku Osaka-shi 556-0014
Tel
06-6632-9915
n-deguchi@kih.koudoukai.jp
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
| 2017 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033554
