UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	functional recovery for displaced femoral neck fracture after reduction
Title of the study (Brief title)	functional recover for displaced femoral neck fracture
Region	Japan

Condition
Condition	femoral neck fracture
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare muscular strength, radiographic assessement, and function between operative and non-operative side.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	better muscular strength compared to contralateral side Postoperative follow-up requires at least 6months and one year or more.
Key secondary outcomes	radiographic finding will be satisfactory probably due to less non-union, osteonecrosis of femoral head. Radiographic evaluation can be conducted after 3months at earliest.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	during the operative procedure we reduce displaced fragment under control of image intensifier. When displacement can be successfully reduced, internal fixation was applied.
Interventions/Control_2	no reduction of the fragment
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	displaced femoral neck fracture
Key exclusion criteria	combined Osteoarthritis, bilateral fracture severe dimentia CNS and peripheral nerve trouble
Target sample size	20

Research contact person
Name of lead principal investigator	noda mitsuaki
Organization	Konan hospital
Division name	orthopedic department
Address	Kobe, higasinada, kamokogahara1-5-16
TEL	81-78-851-2161
Email	m-noda@muf.biglobe.ne.jp

Public contact
Name of contact person	noda mitsuaki
Organization	Konan hospital
Division name	orthopedic department
Address	Kobe, higasinada, kamokogahara1-5-16
TEL	81-78-851-2161
Homepage URL
Email	m-noda@muf.biglobe.ne.jp

Sponsor
Institute	No payment accepted.
Institute
Department

Funding Source
Organization	Same s above
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 06 Month 30 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 11 Month 15 Day
Anticipated trial start date	2016 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 20 Day
Last modified on	2017 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030566