UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049800 |
|---|---|
| Receipt number | R000056681 |
| Scientific Title | Prospective interventional study comparing the use of 230 mmHg tourniquet pressure versus 280 mmHg in total knee arthroplasty. |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2022/12/15 23:11:07 |
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Basic information
Public title
Prospective interventional study comparing the use of 230 mmHg tourniquet pressure versus 280 mmHg in total knee arthroplasty.
Acronym
Prospective interventional study comparing the use of 230 mmHg tourniquet pressure versus 280 mmHg in total knee arthroplasty.
Scientific Title
Prospective interventional study comparing the use of 230 mmHg tourniquet pressure versus 280 mmHg in total knee arthroplasty.
Scientific Title:Acronym
Prospective interventional study comparing the use of 230 mmHg tourniquet pressure versus 280 mmHg in total knee arthroplasty.
Region
| Japan |
Condition
Condition
kenn osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal tourniquet pressure to prevent intraoperative blood loss and minimize postoperative pain and complications in Total knee arthroplasty
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain at tourniquet infration is evaluated with a Visual Analogue Scale from 0 to 10 on postoperative day 1.
Key secondary outcomes
pain at the tourniquet infration on postoperative day 2 and 2 weeks,and wound pain on postoperative day 1, 2, and 2 weeks using the VAS.
Leg swelling is evaluated by femoral and lower leg circumference on preoperative and postoperative day 1.
Postoperative complications.
Joint range of motion at 2 and 6 weeks postoperatively.
Clinical scores at preoperative and 6 weeks postoperative are evaluated by questionnaire(knee injury and osteoarthritis score).
Intraoperative and postoperative blood loss evaluated by blood sampling data.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervene the pressure of the tourniquet used during total knee arthroplasty.
The patients will be divided into two groups: one using a pressure of 230 mmHg.
Interventions/Control_2
the other using a pressure of 280 mmHg
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with primary knee osteoarthritis who underwent a TKA.
Key exclusion criteria
Patients with a history of venous thromboembolism,bleeding disorder,sever hypertension(systolic blood pressure over 180, diastolic blood pressure over 110),chronic kidney disease stage 3 or above,body mass index over35.
Cases in which postoperative results could not be recorded.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Musha |
Organization
School of Medicine, Toho University (Ohashi)
Division name
Department of Orthopaedics Surgery
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro-ku, Tokyo,Japan
TEL
03-3468-1251
musha@oha.thoho-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Nakayama |
Organization
School of Medicine, Toho University (Ohashi)
Division name
Ethics Committee Secretariat, Research Consultation Office
Zip code
153-8515
Address
2-22-36 Ohashi, Meguro-ku, Tokyo,Japan
TEL
03-3468-1251
Homepage URL
ohashi.rinri@ext.toho-u.ac.jp
Sponsor or person
Institute
School of Medicine, Toho University (Ohashi)
Institute
Department
Personal name
Katsuhisa Ishii
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
Department of Orthopaedics Surgery, School of Medicine, Toho University (Ohashi)
Address
2-22-36 Ohashi, Meguro-ku, Tokyo,Japan
Tel
03-5433-3083
ohashi-seikei@ext.toho-u.ac.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
東邦大学医療センター大橋病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056681
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| Registered date | File name |
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