- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184896
Services Mapping Among Older Adults With Hip Fracture (HiFit)
February 3, 2020 updated by: The George Institute for Global Health, China
Multicenter Prospective Observational Study in Hip Fracture Among Older Adults
Hip fracture is a osteoporosis-related fracture with higher mortality, and is a major public health issue in China.
The British Orthopedic Association and the British Geriatric Society have published the UK Blue Book, which summarizes current evidence and best practice in the hip fracture care and secondary prevention, but this kind of standardized practice in hip fracture care is not yet existed in China.
The Blue Book standards will be used as the most contemporary evidence-based guidelines for management of hip fracture.This study is to prospectively examine the barriers and facilitators in the current management of hospital in China by comparing the Blue Book standards.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
2500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100088
- The George Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have a history of an acute injury that occurred within 21 days, and diagosed by X-ray will be recruited in this study.
Description
Inclusion Criteria:
- Adults aged 65 years old or over;
- Hip fracture with X-ray-confirmed femoral neck, trochanteric or sub-trochanteric fracture;
- Within 21 days of a hip fracture;
- Willingness to sign informed consent form;
Exclusion Criteria:
- Patients with pathological fractures;
- With terminal malignancies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hip Fracture
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Hip Fracture Surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative administration within 48 hours
Time Frame: One year
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The proportion of patients who are operated within 48 hours in the past one year
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A&E Admission within 4 hours
Time Frame: One year
|
The proportion of patients who admit to orthopaedic ward from A&E within 4 hours in the past one year
|
One year
|
The Incidence of Pressure Ulcer
Time Frame: One year
|
The incidence of pressure ulcer in the past one year via nurses provide assessment
|
One year
|
The Proportion of Patients Who Receive Geriatrician Assessment
Time Frame: One year
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The proportion of patients who receive the assessment of geriatricians in the past one year
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One year
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The Proportion of Patients Who Receive Osteoporosis Assessment and Treatment
Time Frame: One year
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The proportion of patients who receive osteoporosis assessment and treatment the hospital provided in the past one year
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One year
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The Proportion of Patients Who Receive Specialist Falls Assessment
Time Frame: One year
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The proportion of patients who receive specialist falls assessment in the past one year
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One year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality Rate in One Month, Four-Month, and One Year
Time Frame: One month, four-month, and one year
|
The mortality rate in one, four-month, and one year after admission to hospital
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One month, four-month, and one year
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The Incidence of Complications in One Month, Four-Month, and One year
Time Frame: One month, four-month, and one year
|
The incidence of complications in one month, four-month and one year after admission to hospital, including pneumonia, deep vein thrombosis, heart disease, etc.
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One month, four-month, and one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 14, 2018
Primary Completion (ANTICIPATED)
November 13, 2021
Study Completion (ANTICIPATED)
November 13, 2021
Study Registration Dates
First Submitted
June 8, 2017
First Submitted That Met QC Criteria
June 11, 2017
First Posted (ACTUAL)
June 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 3, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0281001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
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Smith & Nephew, Inc.Terminated
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Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
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Carilion ClinicCompleted
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FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
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Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
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Bayside HealthCompleted
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Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
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Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
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University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
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Rabin Medical CenterUnknown
Clinical Trials on Hip Fracture Surgery
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Oslo University HospitalRecruiting
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Centre Hospitalier Universitaire de NīmesCompleted
-
Sahlgrenska University Hospital, SwedenCompleted
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Aga Khan UniversityCompleted
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Brno University HospitalSt. Anne's University Hospital Brno, Czech RepublicCompletedFracture of Neck of Femur (Hip)Czech Republic
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University of NottinghamRecruitingPostoperative Delirium | Older People | Hip Fracture SurgeryUnited Kingdom
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University of British ColumbiaActive, not recruitingCOVID-19 | Hip Fractures | Spinal Anesthesia | General AnesthesiaCanada
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Hvidovre University HospitalCompletedDelirium | AnemiaDenmark
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Fundació Institut de Recerca de l'Hospital de la...Not yet recruiting