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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034561
Receipt No. R000038270
Official scientific title of the study An open-label, uncontrolled study of ADAPT system in femoral trochanter fracture surgery
Date of disclosure of the study information 2018/11/05
Last modified on 2018/10/18

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Basic information
Official scientific title of the study An open-label, uncontrolled study of ADAPT system in femoral trochanter fracture surgery
Title of the study (Brief title) An open-label, uncontrolled study of ADAPT system in femoral trochanter fracture surgery
Region
Japan

Condition
Condition Patients who are scheduled to use the gamma 3 locking nail system in osteosynthesis at the Nagoya Medical Center orthopedic surgery who was diagnosed as a femoral trochanter fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the usefulness of ADAPT (the gamma 3 rocking nail intraoperative support system) in patients with a femoral trochanter fracture
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Irradiation time
Key secondary outcomes (1)Operation time
(2)Fracture type
(3)TAD (Tip-apex distance; sum of the distance between the front of the femoral head and the tip of the implant)
(4)Repetition position
(5)Adverse events

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention by surgical technique using ADAPT in femoral trochanter fracture treatment.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Diagnosed with a femoral trochanter fracture by imaging and able to use the gamma 3 locking nail system for osteosynthesis
(2) Those who can receive operation
within 4 weeks after injury.
(3) Aged 20 years or older at the time of consent
(4) Provided written consent by themselves after full explanation to participate in this study
Key exclusion criteria (1)Patients judged by the principal investigator to be inappropriate as subjects
Target sample size 25

Research contact person
Name of lead principal investigator Koichi Mori
Organization National Hospital Organization Nagoya Medical Center
Division name Orthopedic Surgery and Rheumatology
Address 4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL 052-951-1111
Email k-mori@nnh.hosp.go.jp

Public contact
Name of contact person Koichi Mori
Organization National Hospital Organization Nagoya Medical Center
Division name Orthopedic Surgery and Rheumatology
Address 4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL 052-951-1111
Homepage URL
Email k-mori@nnh.hosp.go.jp

Sponsor
Institute National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization Nagoya Medical Center
Organization
Division
Category of Funding Organization Self funding
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 独立行政法人 国立病院機構 名古屋医療センター(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 15 Day
Anticipated trial start date
2018 Year 11 Month 05 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
2018 Year 10 Month 18 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038270

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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