UMIN-CTR Clinical Trial

Basic information
Public title	Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Acronym	Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Scientific Title	Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Scientific Title:Acronym	Effect of cement augmentation on early postoperative ADL score in patients treated with cephalomedullary nailing for trochanteric fractures
Region	Japan

Condition
Condition	patients of femoral intertrochanteric fracture
Classification by specialty	Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effect of cement augmentation on early postoperative ADL scores in patients with trochanteric fractures
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cumulated Ambulation Score(CAS) at postoperative days 1, 2, 3
Key secondary outcomes	Barthel index at post-op 1 week, walking ability (wheelchair, parallel bars, walker, cane, walking alone) CAS at postoperative days 5

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	open reduction with cement augmentation
Interventions/Control_2	open reduction without cement augmentation
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	trochanteric fractures for the first time (Fracture type: AO/OTA classification 31A), age 60 years old above who able to walk independently before the injury (walking with a walker or higher, wheelchairs are excluded)
Key exclusion criteria	pathological fractures, open fractures, history of allergy to cement, multiple lower extremity trauma, postoperative non weight bearing, postoperative medical complications that make it difficult to leave the bed (pneumonia, heart failure, etc.)
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Mochizuki
Organization	Kaneda Hospital
Division name	orthopedics
Zip code	719-3193
Address	63, Nishihara, Maniwa city, Okayama
TEL	0867521191
Email	catchernine4949@yahoo.co.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Mochizuki
Organization	Kaneda Hospital
Division name	orthopedics
Zip code	719-3193
Address	63, Nishihara, Maniwa city, Okayama
TEL	0867521191
Homepage URL
Email	catchernine4949@yahoo.co.jp

Sponsor
Institute	Kaneda Hospital
Institute
Department

Funding Source
Organization	Kaneda Hospital
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	Kaneda Hospital
Address	63, Nishihara, Maniwa city, Okayama
Tel	0867521191
Email	catchernine4949@yahoo.co.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 04 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	Open public recruiting
Date of protocol fixation	2021 Year 01 Month 31 Day
Date of IRB	2021 Year 02 Month 11 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2022 Year 03 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	2021 Year 04 Month 15 Day
Last modified on	2021 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050163