UMIN-CTR Clinical Trial

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
Email	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
Email	k_inui2@nakatsu.saiseikai.or.jp

Sponsor
Institute	Osaka Saiseikai Nakatsu Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050695