UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044379 |
|---|---|
| Receipt number | R000050695 |
| Scientific Title | A cross-sectional study of skeletal muscle mass in patients with fragility proximal femoral fractures. |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/06/02 14:43:30 |
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Basic information
Public title
A cross-sectional study of skeletal muscle mass in patients with fragility proximal femoral fractures.
Acronym
MuMaFra
Scientific Title
A cross-sectional study of skeletal muscle mass in patients with fragility proximal femoral fractures.
Scientific Title:Acronym
MuMaFra
Region
| Japan |
Condition
Condition
fragility proximal femoral fractures
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among fragility fractures based on osteoporosis, proximal femoral fracture is one of the most common causes of bedridden patients, so early intervention including surgery is important. Although various factors have been proposed to affect the outcome of treatment, the involvement of skeletal muscle mass has rarely been reported, and this study will clarify this issue.
Basic objectives2
Others
Basic objectives -Others
Patients admitted to our hospital for treatment of osteoporosis-based proximal femoral fractures will undergo bone mineral density measurement at an appropriate time during hospitalization (generally within 2 weeks after surgery) in addition to the usual medical examination. Dual-energy X-ray absorptiometry of the healthy side of proximal femur and the whole body will be measured to investigate the relationship between skeletal muscle mass at the time of injury and the degree of recovery of postoperative motor function.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between skeletal muscle mass at the time of injury and the degree of postoperative motor function recovery in patients with fragility proximal femoral fractures
Key secondary outcomes
1.Prevalence of sarcopenia at the time of injury in patients with fragility fracture of the proximal femur
2. Relationship between skeletal muscle mass and bone mineral density at the time of injury in patients with fragility proximal femoral fractures
3. Relationship between skeletal muscle mass at injury and fracture type in patients with fragility proximal femoral fracture.
4. Relationship between skeletal muscle mass at injury and bone metabolic markers in patients with fragility proximal femoral fracture.
5. Relationship between skeletal muscle mass at injury and pre-injury motor function in patients with fragility proximal femoral fracture.
6. Relationship between skeletal muscle mass at injury and postoperative outcomes in patients with fragility proximal femoral fractures.
Translated with www.DeepL.com/Translator (free version)
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
_Between the approval date of the Ethics Committee and December 31, 2024
_Patients admitted to the Department of Orthopaedic Surgery at Saiseikai Nakatsu Hospital with fragility of proximal femoral fracture
Key exclusion criteria
_Patients for whom necessary tests cannot be performed
_Other patients deemed inappropriate by the physician in charge
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Inui |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Department of Orthopaedic Surgery
Zip code
530-0012
Address
2-10-39 Shibata, kita-Ku, Osaka CIty
TEL
06-6372-0333
k_inui2@nakatsu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Inui |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Department of Orthopaedic Surgery
Zip code
530-0012
Address
2-10-39 Shibata, kita-Ku, Osaka CIty
TEL
06-6372-0333
Homepage URL
k_inui2@nakatsu.saiseikai.or.jp
Sponsor or person
Institute
Osaka Saiseikai Nakatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Saiseikai Nakatsu Hospital
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
Ethics Committee of Osaka Saiseikai Nakatsu Hospital
Address
2-10-39 Shibata, kita-Ku, Osaka CIty
Tel
06-6372-0333
k_inui2@nakatsu.saiseikai.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
| 2021 | Year | 10 | Month | 01 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | 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
1) Basic patient information: age, sex, diagnosis, body mass index, complications and past history (circulatory disease, metabolic disease, stroke, osteoporosis, depression, cognitive disorder), osteoporosis treatment, ADL before and after injury
2) Blood test: CBC, AST, ALT, serum Cre, eGFR, CRP, LDH, ALP, CK, TP, Alb, 25OH-VitD, bone metabolic marker
3) X-ray examination
4) CT image
5) Dual-energy X-ray Absorptiometry: Whole Body Model and Proximalfemur
6) Information on fracture: period from injury to surgery, fracture type
(7) Surgery: operation time, blood loss, operation method, and intraoperative special notes
Management information
Registered date
| 2021 | Year | 05 | Month | 31 | Day |
Last modified on
| 2021 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050695
