UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019328 |
|---|---|
| Receipt number | R000022347 |
| Scientific Title | Japanese outcomes in neck fracture |
| Date of disclosure of the study information | 2015/10/13 |
| Last modified on | 2021/10/27 11:05:05 |
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Basic information
Public title
Japanese outcomes in neck fracture
Acronym
JOIN
Scientific Title
Japanese outcomes in neck fracture
Scientific Title:Acronym
JOIN
Region
| Japan |
Condition
Condition
Femoral neck fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the outcomes, indication, and clinical questions on BHA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative outcomes(3 years)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are candidate for BHA.
2) Patients have diagnosis of Femoral Neck Fracture.
3) Patients are age 20 or over.
4) Patients, who agree on an IRB-approved, study specific Informed Patient Consent Form
5) Patients are willing and able to comply with postoperative scheduled evaluations.
Key exclusion criteria
Patients have bacterial infectious disease or have risk highly of bacterial infection.
2) Patients are lower ADL, that is using wheelchair and bedridden.
3) Patients have a severe bone deformity by rheumatism or osteotomy.
4) Patients who is pregnant female or maybe so.
5) Patients who are judged ineligible with reasonable reason by primary doctor.
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Jinno |
Organization
Tokyo Medical Dental University
Division name
Orthopaedic
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510
TEL
03-3813-6111
jinno.ort@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Suzuki |
Organization
Stryker Japan K.K.
Division name
Clinical Affairs
Zip code
Address
2-6-1 Koraku, Bunkyo-ku, Tokyo 112-0004
TEL
03-6894-8357
Homepage URL
kenta.suzuki@stryker.com
Sponsor or person
Institute
Stryker Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
Stryker Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Radiographic evaluation
Functional score
Patient's satisfaction
Management information
Registered date
| 2015 | Year | 10 | Month | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022347
