UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041206 |
|---|---|
| Receipt number | R000047054 |
| Scientific Title | Fracture liaison service to reduce postoperative complications and to improve activity of patients with hip fracture 24 months' follow-up survey |
| Date of disclosure of the study information | 2020/07/24 |
| Last modified on | 2020/07/24 22:16:44 |
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Basic information
Public title
Fracture liaison service to reduce postoperative complications and to improve activity of patients with hip fracture 24 months' follow-up survey
Acronym
Fracture liaison service to reduce postoperative complications and to improve activity of patients with hip fracture 24 months' follow-up survey
Scientific Title
Fracture liaison service to reduce postoperative complications and to improve activity of patients with hip fracture 24 months' follow-up survey
Scientific Title:Acronym
Fracture liaison service to reduce postoperative complications and to improve activity of patients with hip fracture 24 months' follow-up survey
Region
| Japan |
Condition
Condition
Hip fracture, neck fracture and trochnateric fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We included patients with fragility hip fracture, femoral neck fracture, and trochanteric fracture, and injury aged exceeding 50 years, between January 1, 2015, and December 31, 2017. We divided patients into a control group without FLS (94 patients; age: 83.8 years; 21 men and 73 women) and an FLS group (373 patients; age: 83.3 years; 69 men and 304 women).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Age (in years), sex, the days from injury to surgery, and the rate at which surgery occurred within 36 hours from injury, number and rate of cases that had undergone any surgery, and average hospital stay (days) were recorded. Additionally, comorbidity at surgery (as classified in our previous study: hypertension, cardiovascular disease, pulmonary disease, renal disease, diabetes, cerebrovascular disease, digestive disease), complications newly occurring after admission, including those that involved worsening of a comorbidity, and hip fracture on the opposite side within 12 months and within 24 months after the first hip fracture were also investigated.
We also examined the rate of taking anti-osteoporosis medicine, activities of daily living as evaluated by the Barthel index (BI) , and the rate of the patients whose BI was 80 and more, which was considered as indicator of independent daily activity. These parameters were evaluated at the time before injury, and 3 months, 6 months, 12 months, and 24 months after their injury. Moreover, mortality was examined within 1 month, 12 months, and 24 months after their injury, respectively. In terms of taking anti-osteoporosis medicine and activity of daily living as evaluated by the BI, the patients who died and who could not be traced were excluded from the analysis at each time-point. These data were obtained from medical records and telephone calls or by mail to the patients or their family, by a specialized liaison nurse qualified by the Japan Osteoporosis Society.
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with fragility hip fracture
Key exclusion criteria
Pathological fracture, high energy injury
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | IMAI |
Organization
Niigata University Graduate School of Medical and Dental Sciences, Japan
Division name
Division of Comprehensice Muscloskeletal Medicine,
Zip code
9518510
Address
1-757, Asahimachidori, Niigata city, Niigata Prefecture, Japan
TEL
0252272272
imainorio2001@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | IMAI |
Organization
Niigata University Graduate School of Medical and Dental Sciences, Japan
Division name
Division of Comprehensice Muscloskeletal Medicine,
Zip code
9518510
Address
1-757, Asahimachidori, Niigata city, Niigata Prefecture, Japan
TEL
0252272272
Homepage URL
imainorio2001@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences, Japan
Institute
Department
Personal name
Funding Source
Organization
None
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
Niigata University School of Medicine
Address
1-757, Asahimachidori, Niigata City, Niigata Prefecture
Tel
0252272272
imainorio2001@med.niigata-u.ac.jp
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
| 2020 | Year | 07 | Month | 24 | 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
577
Results
The days from injury to surgery was significantly decreased, from 2.42 days to 1.83 days, after introduction of the FLS. In terms of complications after admission, a significant decrease was observed in the total number of cases, cardiovascular disease, pulmonary disease, and cerebrovascular disease in the FLS group. There was significantly more patients with a Barthel Index more than 80 in the FLS group at 6 months, 12 months, and 24 months after their injury
Results date posted
| 2020 | Year | 07 | Month | 24 | Day |
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 | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047054
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