UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034561 |
|---|---|
| Receipt number | R000038270 |
| Scientific Title | 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 | 2020/05/15 12:14:26 |
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Basic information
Public title
An open-label, uncontrolled study of ADAPT system in femoral trochanter fracture surgery
Acronym
An open-label, uncontrolled study of ADAPT system in femoral trochanter fracture surgery
Scientific Title
An open-label, uncontrolled study of ADAPT system in femoral trochanter fracture surgery
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Koichi Mori |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL
052-951-1111
k-mori@nnh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Mori |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1,Sannomaru,Naka-ku,Nagoya-shi, Aichi, 460-0001, Japan
TEL
052-951-1111
Homepage URL
k-mori@nnh.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038270
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
