UMIN-CTR Clinical Trial

Basic information
Public title	Impact of a hip fracture template on perioperative complication rate in hip fracture co-management by hospitalists: a retrospective cohort study
Acronym	Impact of HFT on perioperative complication rate in hip fracture co-management by hospitalists
Scientific Title	Impact of a hip fracture template on perioperative complication rate in hip fracture co-management by hospitalists: a retrospective cohort study
Scientific Title:Acronym	Impact of HFT on perioperative complication rate in hip fracture co-management by hospitalists
Region	Japan

Condition
Condition	hip fracture
Classification by specialty	Medicine in general Orthopedics Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examined its effect on morbidity in patients with hip fractures and the factors associated with complications.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	perioperative complication rate
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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients who underwent surgery for hip fracture in Akashi medical center between July 2020 and September 2021
Key exclusion criteria	patients with periprosthetic fracture
Target sample size	243

Research contact person
Name of lead principal investigator	1st name Naoto Middle name Last name Ishimaru
Organization	Akashi Medical Center
Division name	Department of General Internal Medicine
Zip code	6740063
Address	743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL	0789361101
Email	maru-tkb@umin.ac.jp

Public contact
Name of contact person	1st name Naoto Middle name Last name Ishimaru
Organization	Akashi Medical Center
Division name	Department of General Internal Medicine
Zip code	6740063
Address	743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
TEL	0789361101
Homepage URL
Email	maru-tkb@umin.ac.jp

Sponsor
Institute	Akashi Medical Center
Institute
Department

Funding Source
Organization	None
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	Akashi Medical Center
Address	743-33 Yagi, Ohkubo-cho, Akashi, Hyogo 674-0063, Japan
Tel	0789361101
Email	yokoyama.naoki@aijinkai-group.com

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	2022 Year 02 Month 06 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	Completed
Date of protocol fixation	2021 Year 12 Month 23 Day
Date of IRB	2022 Year 01 Month 24 Day
Anticipated trial start date	2022 Year 01 Month 27 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	Demographic data, items used in the template, and comorbidities were obtained from patient's charts.

Management information
Registered date	2022 Year 02 Month 06 Day
Last modified on	2022 Year 08 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053439