Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)NCT07847164
Cohort Study on the Prognosis and Influencing Factors in Elderly Patients With Hip Fractures in Multicenter of China
An observational study of Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), run by Beijing Hospital at 1 site in China.
Trial summary
To address the difficulties and problems currently facing large-scale clinical cohort studies in China, and on the basis of the existing project "Construction of Clinical Registration Database and Risk Assessment System for Osteoporosis and Osteoarthritis" under the National Key R\&D Program of the Ministry of Science… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hip fracture inpatients at grade-A tertiary hospitals across China
Inclusion Criteria:1: The subjects are of Chinese nationality.
2: The subject is 60 years of age or older (including the boundary value)
3:The subject has been diagnosed with hip fracture by imaging, including femoral neck fracture, intertrochanteric fracture of femur, and subtrochanteric fracture of femur
4: Patients who were hospitalized for hip fracture treatment (surgical or conservative) after September 1, 2022
5: The subject can fully understand and sign the informed consent form.
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Exclusion Criteria:1: Pathological fractures caused by primary or metastatic tumors of bone or bone developmental disorders
2: Patients with peri-implant fractures or polytrauma (multiple injuries resulting from a single traumatic event in which two or more anatomical sites in the body are severely injured, with one of them being severely injured even in the absence of the traumatic event also posing a life-threatening risk)
3: Subjects who, in the opinion of the investigator, are not eligible for enrollment in the study.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100000
ze zhang, doctoral degree, +86-18810599419, 1911210691@pku.edu.cn
zhaoshuo he, doctoral degree, +86-17852326007, 1747493731@qq.com
About this study
To address the difficulties and problems currently facing large-scale clinical cohort studies in China, and on the basis of the existing project "Construction of Clinical Registration Database and Risk Assessment System for Osteoporosis and Osteoarthritis" under the National Key R\&D Program of the Ministry of Science and Technology, this project aims to target elderly hip fracture-an international public health issue-by collaborating with 38 hospitals across the country to jointly establish the largest specialized cohort for elderly hip fracture in China, thereby providing a data platform and technical support for multicenter clinical cohort studies on elderly hip fracture.
Read the detailed description
- Building upon the project of the 14th Five-Year Plan, we aim to further expand the scope by establishing a clinical collaboration system involving multiple tertiary A hospitals across the country. Based on this system, we will define unified inclusion and exclusion criteria for case enrollment and establish the largest national multicenter clinical disease-specific cohort of geriatric hip fractures in China.
- We will prospectively collect baseline information, social data, pre-existing comorbidities and other unrelated medical history, genetic-related information, physical examination findings, laboratory and biochemical data, imaging examinations, and other relevant data from elderly patients (aged 60 years and above) with hip fractures.
- We will collect information on diagnosis and treatment during the patient care episode (including surgery, non-surgical management, anti-osteoporosis therapy, etc.) to build a clinical diagnosis and treatment information database.
- After the completion of the treatment course, we will conduct a 1- to 2-year follow-up, focusing on survival status, re-fractures, medical comorbidities, surgery-related complications, and post-discharge home care arrangements. This will enable the development of a standardized follow-up system for prognostic research on geriatric hip fractures.
- Keywords
- Hip fractures (i.e. femoral neck or intertrochanteric hip fractures)
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A cohort of elderly patients with hip fracture | A cohort of elderly patients with hip fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Post-hip fracture mortality (yes/no)
Measured: Six months, one year, and two years after hip fracture
Secondary outcomes (11)
Clavien-Dindo classification of complications
Clavien-Dindo classification of complications
Measured: Six months, one year, and two years after hip fracture
Conservative treatment status for patients managed non-surgically
Conservative treatment status for patients managed non-surgically
Measured: Six months, one year, and two years after hip fracture
Imaging data
Imaging data
Measured: one day，Six months, one year, and two years after hip fracture
Other new adverse events
Other new adverse events
Measured: Six months, one year, and two years after hip fracture
Place of residence at follow-up.
Place of residence at follow-up.
Measured: Six months, one year, and two years after hip fracture
Post-hospital care
Post-hospital care
Measured: Six months, one year, and two years after hip fracture
Anti-osteoporosis treatment status
Anti-osteoporosis treatment status
Measured: Six months, one year, and two years after hip fracture
EQ-5D Quality of Life score
EQ-5D Quality of Life score
Measured: Six months, one year, and two years after hip fracture
Time to discontinuation of strict bed rest
Time to discontinuation of strict bed rest
Measured: Six months, one year, and two years after hip fracture
Refracture event
Refracture event
Measured: Six months, one year, and two years after hip fracture
FAC Functional Walking Scale
FAC Functional Walking Scale
Measured: Six months, one year, and two years after hip fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, wenliangyuan, Beijing Hospital
- Investigators
- liangyuan wen, doctoral degree, Study chair, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847164
- Sponsor's protocol ID
- BJ-2024-145
- Other IDs
- BJ-2024-145
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) from this nationwide multicenter prospective cohort of elderly patients with hip fracture will be shared. The shared dataset includes: (1) demographic and baseline characteristics (age, sex, comorbidities, frailty and functional status); (2) injury and treatment details (fracture type, surgical procedure, anesthesia method, timing of surgery); (3) perioperative management data (blood transfusion, rehabilitation); and (4) outcome data at each follow-up time point (mortality, complications, reoperation, functional scores such as FAC or EQ-5D, and quality of life). All direct identifiers (name, ID number, phone, address, hospital record number) will be removed before sharing. Data from individual centers will be pooled after harmonization across sites.