UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058103 |
|---|---|
| Receipt number | R000066407 |
| Scientific Title | A multi-center RCT on skin incision in total hip arthroplasty: OCM T-I project |
| Date of disclosure of the study information | 2025/06/06 |
| Last modified on | 2025/06/06 12:54:21 |
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Basic information
Public title
A clinical study for evaluating patient satisfaction of wound healing and patient safety after total hip arthroplasty with transverse skin incision
Acronym
Transverse skin incision study
Scientific Title
A multi-center RCT on skin incision in total hip arthroplasty: OCM T-I project
Scientific Title:Acronym
OCM T-I project
Region
| Japan |
Condition
Condition
Hip joint diseases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate patient satisfaction for wound healing and patient safety in THA using transverse skin incision
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Wound healing (Difference between groups in scar assessment scores (POSAS, JSW Scar Scale) at 12 months postoperatively)
Key secondary outcomes
Wound healing (Difference between groups in scar assessment scores (POSAS, JSW Scar Scale) at 3 months postoperatively and 6 months), psychological impact of wound healing (MPIS), difficulty of each skin incision (Operative time, Implant alignment), clinical assessment scores (JOA, HHS, JHEQ, FJS-12), complications, length of skin incision, necessity of additional skin incision, and effect of switching to transverse incision based on surgeon's experience with OCM approach
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
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Transverse skin incision for surgical approach to hip joint
Interventions/Control_2
Longitudinal skin incision for surgical approach to hip joint
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are candidate for THA with OCM approach
2. Patients who are expected to be followed up for at least 6 months postoperatively
3. Patients who are deemed to use the following device/implants (To eliminate evaluation bias due to device/implant model): AR Hip Navigation (Surgical navigation), G7 Cup (Acetabular cup), Vivacit-E Liner (Acetabular liner), Delta Ceramic Head with over 32 mm outside diameter (Femoral head), Avenir Complete Stem (Femoral stem)
4. Patients who are deemed to use the following tool (To eliminate evaluation bias due to tool model): Steri-Strip, Mepilex (Wound dressing)
Key exclusion criteria
1. Patients who do not meet any of the inclusion criteria listed in 4-3-1
2. Patients with have skin diseases
3. Patients with dislocation hip
4. Patients with history of hip surgery(ies)
5. Patients who are eligible Cases a cup with 44 mm diameter or less is appropriate
6. Patients who have took THA for contralateral hip, or scheduled bilateral THA
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Tsukamoto |
Organization
University of Occupational and Environmental Health
Division name
Department of Orthopaedic Surgery
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka, Japan
TEL
+81-93-691-7444
j-seikei@mbox.med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Tsukamoto |
Organization
University of Occupational and Environmental Health
Division name
Department of Orthopaedic Surgery
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka, Japan
TEL
+81-93-691-7444
Homepage URL
j-seikei@mbox.med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
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
Clinical Research Review Board of the University of Occupational and Environmental Health, Japan
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka 807-8555, Japan
Tel
+81-93-691-7127
rinshokenkyu@mbox.clnc.uoeh-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066407
