UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059844 |
|---|---|
| Receipt number | R000068435 |
| Scientific Title | Changes in Muscle Strength, Muscle Mass, and Muscle Cross-sectional Area Before and After Spherical Periacetabular Osteotomy for Acetabular Dysplasia |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2025/11/21 00:13:12 |
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Basic information
Public title
Changes in Muscle Strength, Muscle Mass, and Muscle Cross-sectional Area Before and After Spherical Periacetabular Osteotomy for Acetabular Dysplasia
Acronym
Changes in Muscle Strength, Muscle Mass, and Muscle Cross-sectional Area Before and After Spherical Periacetabular Osteotomy for Acetabular Dysplasia
Scientific Title
Changes in Muscle Strength, Muscle Mass, and Muscle Cross-sectional Area Before and After Spherical Periacetabular Osteotomy for Acetabular Dysplasia
Scientific Title:Acronym
Changes in Muscle Strength, Muscle Mass, and Muscle Cross-sectional Area Before and After Spherical Periacetabular Osteotomy for Acetabular Dysplasia
Region
| Japan |
Condition
Condition
Acetabular Dysplasia
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Muscle strength and muscle mass were measured in female patients prior to acetabular reconstruction surgery and at 1 week, 3 weeks, and 5 weeks postoperatively. Muscle cross-sectional area was also measured preoperatively and at 1 week and 5 weeks postoperatively. The aim is to clarify changes in postoperative muscle strength, muscle mass, and muscle cross-sectional area.
Basic objectives2
Others
Basic objectives -Others
To examine appropriate rehabilitation interventions and discharge instructions tailored to the postoperative course, aiming for early social reintegration after discharge and reduced hip joint burden in SPO patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in muscle strength and muscle mass at pre-operative, 1 week post-operative, 3 weeks post-operative, and 5 weeks post-operative; changes in muscle cross-sectional area at pre-operative, 1 week post-operative, and 5 weeks post-operative
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
A female patient who underwent an Spherical Periacetabular Osteotomy for acetabular dysplasia
Key exclusion criteria
Patients with neurological or psychiatric disorders,Patients with implanted medical devices such as pacemakers,Patients deviating from the clinical pathway,
Patients who developed severe neurological paralysis or fractures postoperatively
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seiko |
| Middle name | |
| Last name | Kawahara |
Organization
Department of Rehabilitaion,Kanazawa Medical University Hospital
Division name
Department of Rehabilitaion
Zip code
920-0293
Address
1-1 Daigaku,Utinada,Kahoku District,Ishikawa Prefecture,Japan
TEL
076-286-3511
se15@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Kawahara |
Organization
Kanazawa Medical University Hospital
Division name
Department of Rehabilitaion
Zip code
920-0293
Address
1-1 Daigaku,Utinada,Kahoku District,Ishikawa Prefecture,Japan
TEL
076-286-3511
Homepage URL
se15@kanazawa-med.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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
Kanazawa Medical University Hospital
Address
1-1 Daigaku,Utinada,Kahoku District,Ishikawa Prefecture,Japan
Tel
076-286-3511
se15@kanazawa-med.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 | 03 | Month | 20 | 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
13
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
other
Management information
Registered date
| 2025 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068435
