UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063284 |
|---|---|
| Receipt number | R000072435 |
| Scientific Title | Association between preoperative CT-derived trunk muscle cross-sectional area and walking ability one month after surgery in patients with proximal femoral fractures |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/14 22:52:47 |
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Basic information
Public title
Study of the association between preoperative trunk muscle size and walking ability one month after surgery in patients with proximal femoral fractures
Acronym
Study of trunk muscle size and walking ability in patients with proximal femoral fractues
Scientific Title
Association between preoperative CT-derived trunk muscle cross-sectional area and walking ability one month after surgery in patients with proximal femoral fractures
Scientific Title:Acronym
Association between trunk muscle cross-sectional area and postoperative walking ability after proximal femoral fracture
Region
| Japan |
Condition
Condition
Proximal femoral fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the association between the cross-sectional areaof trunk muscles measured using preoperative CT images and walking ability one month after surgery,as well as to identify independence.The findings are expected to contribute to improving the accuracy of prognosis prediction based on preoperative imaging and developing individualized early rehabilitation programs.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between preoperative CT-derived trunk muscle cross-sectional area and walking ability one month after surgery, and to identify factors associated with walking independence in patients with proximal femoral fractures.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FIM walking item score (7 levels) at one month after surgery for proximal femoral fracture.
Key secondary outcomes
Barthel Index (BI) total score, Timed Up and Go (TUG) test time, pain intensity measured using the Numeric Rating Scale (NRS), and Falls Efficacy Scale-International (FES-I) score at one month after surgery for proximal femoral fracture.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1.Patients admitted to Maki Hospital with a proximal femoral fracture.
2.Age 65 years or older.
3.Scheduled to undergo surgery for a proximal femoral fracture.
4.Patients who have undergone, or are scheduled to undergo, trunk CT as part of routine clinical care.
5.Patients for whom written informed consent has been obtained from the patient or their legally acceptable representative after the purpose of the study has been explained.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded:
1.History of severe orthopedic disease of the contralateral lower limb that affected walking before the injury.
2.Fractures due to high-energy trauma, pathological fractures such as those caused by metastatic bone tumors, or multiple fractures involving other bones.
3.History of severe motor paralysis due to central nervous system disease or similar conditions.
4.Inability to obtain informed consent from the patient or their legally acceptable representative.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tajika |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8945
tajika@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kodaira |
Organization
Maki Hospital
Division name
Department of Rehabilitation
Zip code
370-0075
Address
71-1 Tsukunawamachi, Takasaki, Gunma, Japan
TEL
027-361-8411
Homepage URL
tomoyuki.kodaira090324@gmail.com
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Tsuyoshi Tajika
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Maki Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Human Research Ethics Committee
Address
3-39-15 Showa-machi,Maebashi,Gunma 371-8511,Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2026 | Year | 10 | Month | 15 | 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
| 2026 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational cohort study involving patients aged 65 years or older who are admitted to Maki Hospital with proximal femoral fractures. Cross-sectional areas of the erector spinae, transversus abdominis, rectus abdominis, internal oblique, and external oblique muscles will be measured using preoperative CT images obtained as part of routine clinical care. Clinical information, including age, sex, cognitive function, nutritional status, sarcopenia status, and fracture- and surgery-related factors, will be collected from medical records. Walking ability one month after surgery will be assessed using the walking item of the Functional Independence Measure (FIM). For sensitivity analysis, walking ability will also be classified into four groups: unable to walk (wheelchair users), walker users, T-cane users, and independent walkers. The study will investigate the association between preoperative trunk muscle cross-sectional areas and walking ability one month after surgery, as well as factors associated with postoperative walking ability. Participants will be selected according to the eligibility and exclusion criteria specified in the study protocol, and written informed consent will be obtained from the participants or their legally authorized representatives.
Management information
Registered date
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072435
