UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061193 |
|---|---|
| Receipt number | R000070026 |
| Scientific Title | Ultra-early steroid tape intervention for preventing hypertrophic scars after total knee arthroplasty: a randomized controlled trial |
| Date of disclosure of the study information | 2026/04/08 |
| Last modified on | 2026/04/08 08:45:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Ultra-early steroid tape intervention for preventing hypertrophic scars after TKA: a randomized controlled trial
Acronym
UST-TKA Trial
Scientific Title
Ultra-early steroid tape intervention for preventing hypertrophic scars after total knee arthroplasty: a randomized controlled trial
Scientific Title:Acronym
UST-TKA Trial
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine whether ultra-early initiation of steroid tape therapy at 1 month after total knee arthroplasty is more effective in reducing hypertrophic scar thickness and improving pruritus NRS scores compared with delayed initiation at 3 months postoperatively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thickness of the hypertrophic scar (mm) at 6 months postoperatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Delayed intervention group (Control)
Delayed initiation of steroid tape therapy starting at 3 months after total knee arthroplasty. Steroid tape is applied from postoperative month 3 as part of standard scar management, and scar thickness and pruritus are assessed over time.
Interventions/Control_2
Ultra-early intervention group (Intervention)
Ultra-early initiation of steroid tape therapy starting at 1 month after total knee arthroplasty. Steroid tape is applied from postoperative month 1, and scar thickness and pruritus NRS scores are assessed over time.
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Key inclusion criteria
1. Patients undergoing primary total knee arthroplasty for knee osteoarthritis.
2. Patients with a fully epithelialized incision and no signs of infection at 1 month postoperatively.
3. Patients who wish to receive steroid tape therapy and provide written informed consent.
4. Patients who are able to complete follow-up assessments up to 6 months after surgery.
Key exclusion criteria
Exclusion criteria
- Patients who show any signs of wound infection (e.g., erythema, discharge, warmth) at 1 month postoperatively.
- Patients whose incision is not fully epithelialized and for whom steroid tape application is not considered safe.
- Patients with known allergies to topical steroids or adhesive materials used in the tape.
- Patients receiving immunosuppressive therapy or systemic corticosteroid treatment.
- Patients with severe dermatologic conditions that may affect wound healing.
- Patients undergoing revision TKA or those with infectious arthritis or other non-primary TKA indications.
- Patients who are unlikely to complete follow-up assessments up to 6 months after surgery.
- Patients who are unable or unwilling to provide written informed consent.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Mikashima |
Organization
Takagi Hospital, Oume Knee Surgery Center
Division name
Oume Knee Surgery Center
Zip code
198-0021
Address
Imadera 5-18-19, Oume City, Tokyo
TEL
0428315255
ymikashima2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Mikashima |
Organization
Takagi Hospital
Division name
Oume Knee Surgery Center
Zip code
198-0021
Address
Imadera 5-18-19 Takagi Hospital
TEL
0428315255
Homepage URL
ymikashima2007@yahoo.co.jp
Sponsor or person
Institute
Yoshinori Mikashima
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
Takagi Hospital Ethics Committee
Address
Imadera 5-18-19, Oume City, Tokyo
Tel
0428315255
yamazaki@takagi-hp.or.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 | 04 | Month | 08 | 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
| 2026 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2028 | Year | 06 | Month | 30 | Day |
Other
Other related information
None in particular
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070026
