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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000016806 |
Receipt No. | R000019481 |
Scientific Title | Development of reinforcement surgery for the unaffected femur in proximal femoral fracture |
Date of disclosure of the study information | 2015/03/17 |
Last modified on | 2015/03/16 |
Basic information | ||
Public title | Development of reinforcement surgery for the unaffected femur in proximal femoral fracture | |
Acronym | Reinforcement surgery for the unaffected femur | |
Scientific Title | Development of reinforcement surgery for the unaffected femur in proximal femoral fracture | |
Scientific Title:Acronym | Reinforcement surgery for the unaffected femur | |
Region |
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Condition | ||
Condition | Proximal femoral fracture | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify whether screw reinforcement surgery for the unaffected proximal femur is effective in reducing its risk of fracture. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Risk of fracture in the unaffected proximal femur |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Screw insertion to reinforce the unaffected proximal femur in the intervention group.
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Interventions/Control_2 | No intervention for the unaffected proximal femur in the control group. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Patients aged 65 years or older with proximal femoral fractures
2) Patients in whom osteosynthesis surgery was selected for the treatment of fracture 3) Informed consent by patients or their family for participation in the study |
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Key exclusion criteria | 1) Patients with bilateral proximal femoral fractures
2) Patients in whom femoral head prosthetic replacement was selected 3) A history of any hip surgery on the unaffected side 4) A history of severe joint destruction or infection in the unaffected hip joint 5) Patients with a high risk of infection 6) Patients in whom any stress other than fracture surgery should be avoided because of severe complications 7) Patients determined by their attending physicians to be inappropriate as subjects in the present study for other reasons |
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Target sample size | 180 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Center for Geriatrics & Gerontology | ||||||
Division name | Department of Orthopedic Surgery | ||||||
Zip code | |||||||
Address | 7-430, Morioka-machi, Obu, Aichi, Japan | ||||||
TEL | +81-562-46-2311 | ||||||
aharada@ncgg.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Center for Geriatrics & Gerontology | ||||||
Division name | Department of Orthopedic Surgery | ||||||
Zip code | |||||||
Address | 7-430, Morioka-machi, Obu, Aichi, Japan | ||||||
TEL | +81-562-46-2311 | ||||||
Homepage URL | |||||||
aharada@ncgg.go.jp |
Sponsor | |
Institute | National Center for Geriatrics & Gerontology |
Institute | |
Department |
Funding Source | |
Organization | The Research Funding for Longevity Sciences from National Center for Geriatrics & Gerontology
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Organization | |
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Other related organizations | |
Co-sponsor | |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019481 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |