UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062319 |
|---|---|
| Receipt number | R000066321 |
| Scientific Title | Safety and Effectiveness of Cooling Therapy After TKA |
| Date of disclosure of the study information | 2026/07/23 |
| Last modified on | 2026/07/23 16:21:32 |
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Basic information
Public title
Safety and Effectiveness of Cooling Therapy After TKA: Comparison of a 48-Hour Continuous Cooling Followed by Intermittent Cooling Protocol with Conventional Cooling
Acronym
Safety and Effectiveness of Cooling Therapy After TKA
Scientific Title
Safety and Effectiveness of Cooling Therapy After TKA
Scientific Title:Acronym
Safety and Effectiveness of Cooling Therapy After TKA
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to develop a cooling device that could be used without hindering the activities of patients in the early postoperative period, and to verify its safety and efficacy by establishing a 14-day postoperative cooling protocol. In a preliminary study involving healthy adults, the safety and cooling efficacy of the new cooling device were confirmed to be satisfactory. Based on these findings, the present clinical trial was conducted to evaluate the device in patients who had undergone TKA.
Translated with DeepL.com (free version)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence and severity of pain
Key secondary outcomes
(1) Degree of inflammation (knee circumference, subcutaneous temperature of the upper pole of the patella, CK, CRP, etc.)
(2) Amount of bleeding (drainage volume, Hg)
(3) Frequency and dosage of analgesic use
(4) Range of motion (ROM), walking distance
(5) Patient's subjective evaluation (satisfaction, WOMAC: Japanese version)
(6) Length of hospital stay
(7) Occurrence of adverse events
(8) Cost-effectiveness
Translated with DeepL.com (free version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
RCT comparing the conventional group and the new cooling method group
Interventions/Control_2
RCT comparing the conventional group and the new cooling method group
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patients who undergo unilateral TKA at the Orthopaedic Surgery Department of International University of Health and Welfare Narita Hospital between 2024, after research ethics approval, and 31 August 2026.
2 Patients who are able to provide written consent to participate in the study of their own free will.
3 Patients who are aged 18 to 90 at the time of obtaining consent.
4 Hospitalised patients.
Key exclusion criteria
1 Bilateral TKA
2 Only one side of the joint
3 Revision replacement
4 Previous surgery on the same joint
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yagi |
Organization
International University of Health and Welfare NARITA Hospital
Division name
Department of Orthopedic Surgery
Zip code
286-8520
Address
Hatakeda 8523 Narita, Chiba
TEL
0476355600
yagiman@gmail.com
Public contact
Name of contact person
| 1st name | Kotoe |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate school of Medicine, International University of Health ands Welfare
Division name
Graduate school of Medicine,
Zip code
286-8520
Address
Hatakeda 8523 Narita, Chiba
TEL
0476355600
Homepage URL
23m3011@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Yagi Mitsuru
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IUHW CHIBA Institutional Review Board
Address
Hatakeda 852 Narita Chiba
Tel
0476355600
rinri_md@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 23 | 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
| 2024 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2026 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066321
