Fracture Lower LegNCT07147504
Relationship Between Mortality Rates of Fractures in Different Sites and Several Factors in Elderly Patients
An observational study of Fracture Lower Leg and Fracture Dislocation of Upper Limb Joint, run by Shanghai 6th People's Hospital.
Trial summary
Background and Purpose: As people age, bones become weaker and break more easily. Older adults (people 60 years and older) who break bones may face serious health problems and have a higher chance of dying compared to younger people. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fracture Lower Leg, Fracture Dislocation of Upper Limb Joint, Spinal Fractures
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Elderly patients aged 60 years and older who underwent surgical treatment for fractures
Who may be able to join
- Patients admitted to the National Orthopedic Center of Shanghai Sixth People's Hospital between January 1, 2010, and December 31, 2019;
- Age ≥ 60 years;
- Shanghai resident registration;
- Diagnosed with limb or spinal fractures and receiving surgical treatment at Shanghai Sixth People's Hospital.
Who cannot join
- Multiple fractures;
- Conservative treatment selected;
- Incomplete medical records.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Retrospective Study on the Relationship Between Mortality Rates of Fractures in Different Sites and Factors Such as Age, Metabolism, and Nutritional Status in Elderly Patients: A Single-center Retrospective Study
Background and Purpose:
As people age, bones become weaker and break more easily. Older adults (people 60 years and older) who break bones may face serious health problems and have a higher chance of dying compared to younger people. The location of the broken bone, a person's age, and overall health may affect the chances of survival.
Read more
This study will conduct a retrospective analysis of medical records from geriatric patients who underwent surgical intervention for bone fractures at Shanghai Sixth People's Hospital between 2010 and 2019. The primary objective is to identify the key prognostic factors associated with post-operative mortality in this patient cohort.
The study will retrospectively analyze the medical records of patients who meet all of the following criteria:
Aged 60 years or older at the time of fracture diagnosis. Residents of Shanghai. Diagnosed with a fracture of the extremities (upper or lower limbs) or the spine.
Underwent surgical intervention for the diagnosed fracture.
The investigators will assess the following variables as potential prognostic factors for post-operative mortality:
Fracture Characteristics: The anatomical location of the fracture (e.g., hip, spine, upper extremity, lower extremity).
Patient Demographics: The patient's age at the time of injury. Physiological Status: Indicators of the patient's nutritional and metabolic health.
Comorbidities: The presence and severity of pre-existing medical conditions.
How investigators will do this study:
This study is designed as a retrospective cohort analysis. Data will be systematically extracted from existing patient medical records. As an observational study, it involves no new interventions or modifications to patient care. The primary endpoint is all-cause mortality, which will be assessed at 1, 3, and 5 years post-operatively to determine long-term survival rates.
Investigators will group participants by:
The location of fracture (20 different bone locations); Age (60-65, 66-70, 71-75, 76-80, and over 80 years old); Nutrition and health status.
Why This Study Matters:
The results of this study will help doctors better understand which older patients are at higher risk after breaking a bone. This information could help healthcare teams provide better care and potentially save lives by identifying patients who need extra attention and treatment.
Study Details:
This study will examine records from approximately 2000 participants; All participants already received their treatment between 2010-2019; No new treatments or procedures will be performed; Participant's privacy will be completely protected; The study will take about 14 months to complete;
This research will help improve care for older adults who experience bone fractures and may guide treatment decisions for future patients.
- Keywords
- fracture, Limb fractures, Spinal fractures, Elderly people, the old, Survival rate
- Medical subject headings
- Spinal Fractures, Fractures, Bone
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 |
|---|---|---|
| Upper limb fractures Group | Not described | |
| Lower limb fracture Group | Not described | |
| Spinal fractures Group | Not described | |
| 60-64 years old Group | Not described | |
| 65-69 years old Group | Not described | |
| 70-74 years old Group | Not described | |
| 75-79 years old Group | Not described | |
| 80 years and above Group | Not described | |
| Normal nutritional status Group | Not described | |
| Malnutrition status Group | Not described | |
| Overnutrition status Group | Not described | |
| Normal metabolism Group | Not described | |
| Abnormal metabolism group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: From enrollment to the end of data collection at 4 months
Fracture-related mortality
Measured: From enrollment to the end of data collection at 4 months
Secondary outcomes (2)
Postoperative complication rate
Measured: From enrollment to the end of data collection at 4 months
Recurrent fracture rate
Measured: From enrollment to the end of data collection at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fracture Lower LegStudies 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
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaoyin Jiang, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147504
- Sponsor's protocol ID
- 2025-KY-231(K)
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study uses medical data involving patients' personal information, and making it public may violate patients' privacy.
Publications
Sine K, Lee Y, Zullo AR, Daiello LA, Zhang T, Berry SD. Incidence of Lower-Extremity Fractures in US Nursing Homes. J Am Geriatr Soc. 2019 Jun;67(6):1253-1257. doi: 10.1111/jgs.15825. Epub 2019 Feb 27.
PubMed 30811581Oertel MJ, Graves L, Al-Hihi E, Leonardo V, Hopkins C, DeSouza K, Bhattacharya RK. Osteoporosis management in older patients who experienced a fracture. Clin Interv Aging. 2016 Aug 22;11:1111-6. doi: 10.2147/CIA.S107720. eCollection 2016.
PubMed 27578967Berry SD, Daiello LA, Lee Y, Zullo AR, Wright NC, Curtis JR, Kiel DP. Secular Trends in the Incidence of Hip Fracture Among Nursing Home Residents. J Bone Miner Res. 2020 Sep;35(9):1668-1675. doi: 10.1002/jbmr.4032. Epub 2020 May 8.
PubMed 32302028Berner JE, Ortiz-Llorens M, Fries CA, Nanchahal J, Jain A; QUINTET Collaborative. Quality of Life after Open Extremity Trauma (QUINTET) study: An international, multicentric, observational, cohort study of quality of life following lower extremity open fractures. J Plast Reconstr Aesthet Surg. 2024 Dec;99:486-493. doi: 10.1016/j.bjps.2024.10.025. Epub 2024 Oct 16.
PubMed 39476530Tarride JE, Burke N, Leslie WD, Morin SN, Adachi JD, Papaioannou A, Bessette L, Brown JP, Pericleous L, Muratov S, Hopkins RB. Loss of health related quality of life following low-trauma fractures in the elderly. BMC Geriatr. 2016 Apr 19;16:84. doi: 10.1186/s12877-016-0259-5.
PubMed 27093957Larsen P, Elsoe R. Long-term effect of lower limb fractures A national register-based cohort study with a mean of 16.7 years follow-up. Injury. 2025 Apr;56(4):112239. doi: 10.1016/j.injury.2025.112239. Epub 2025 Mar 4.
PubMed 40056731
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Relationship Between Mortality Rates of Fractures in Different Sites and Factors Such as Age, Metabolism, and Nutritional Status in Elderly Patients: A Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT07147504
- Acronym / sponsor ID
- 2025-KY-231(K)
- Keywords
- fracture, Limb fractures, Spinal fractures, Elderly people, the old, Survival rate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Purpose:
As people age, bones become weaker and break more easily. Older adults (people 60 years and older) who break bones may face serious health problems and have a higher chance of dying compared to younger people. The location of the broken bone, a person's age, and overall health may affect the chances of survival.
This study will conduct a retrospective analysis of medical records from geriatric patients who underwent surgical intervention for bone fractures at Shanghai Sixth People's Hospital between 2010 and 2019. The primary objective is to identify the key prognostic factors associated with post-operative mortality in this patient cohort.
The study will retrospectively analyze the medical records of patients who meet all of the following criteria:
Aged 60 years or older at the time of fracture diagnosis. Residents of Shanghai. Diagnosed with a fracture of the extremities (upper or lower limbs) or the spine.
Underwent surgical intervention for the diagnosed fracture.
The investigators will assess the following variables as potential prognostic factors for post-operative mortality:
Fracture Characteristics: The anatomical location of the fracture (e.g., hip, spine, upper extremity, lower extremity).
Patient Demographics: The patient's age at the time of injury. Physiological Status: Indicators of the patient's nutritional and metabolic health.
Comorbidities: The presence and severity of pre-existing medical conditions.
How investigators will do this study:
This study is designed as a retrospective cohort analysis. Data will be systematically extracted from existing patient medical records. As an observational study, it involves no new interventions or modifications to patient care. The primary endpoint is all-cause mortality, which will be assessed at 1, 3, and 5 years post-operatively to determine long-term survival rates.
Investigators will group participants by:
The location of fracture (20 different bone locations); Age (60-65, 66-70, 71-75, 76-80, and over 80 years old); Nutrition and health status.
Why This Study Matters:
The results of this study will help doctors better understand which older patients are at higher risk after breaking a bone. This information could help healthcare teams provide better care and potentially save lives by identifying patients who need extra attention and treatment.
Study Details:
This study will examine records from approximately 2000 participants; All participants already received their treatment between 2010-2019; No new treatments or procedures will be performed; Participant's privacy will be completely protected; The study will take about 14 months to complete;
This research will help improve care for older adults who experience bone fractures and may guide treatment decisions for future patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Upper limb fractures Group | – | – |
| Lower limb fracture Group | – | – |
| Spinal fractures Group | – | – |
| 60-64 years old Group | – | – |
| 65-69 years old Group | – | – |
| 70-74 years old Group | – | – |
| 75-79 years old Group | – | – |
| 80 years and above Group | – | – |
| Normal nutritional status Group | – | – |
| Malnutrition status Group | – | – |
| Overnutrition status Group | – | – |
| Normal metabolism Group | – | – |
| Abnormal metabolism group | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients aged 60 years and older who underwent surgical treatment for fractures
Key inclusion criteria (4 listed)
- Patients admitted to the National Orthopedic Center of Shanghai Sixth People's Hospital between January 1, 2010, and December 31, 2019;
- Age ≥ 60 years;
- Shanghai resident registration;
- Diagnosed with limb or spinal fractures and receiving surgical treatment at Shanghai Sixth People's Hospital.
Key exclusion criteria (3 listed)
- Multiple fractures;
- Conservative treatment selected;
- Incomplete medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: From enrollment to the end of data collection at 4 months
Fracture-related mortality
Time frame: From enrollment to the end of data collection at 4 months
2 secondary outcomes
Postoperative complication rate
Time frame: From enrollment to the end of data collection at 4 months
Recurrent fracture rate
Time frame: From enrollment to the end of data collection at 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 30811581Sine K, Lee Y, Zullo AR, Daiello LA, Zhang T, Berry SD. Incidence of Lower-Extremity Fractures in US Nursing Homes. J Am Geriatr Soc. 2019 Jun;67(6):1253-1257. doi: 10.1111/jgs.15825. Epub 2019 Feb 27.
- Results publication: PubMed 27578967Oertel MJ, Graves L, Al-Hihi E, Leonardo V, Hopkins C, DeSouza K, Bhattacharya RK. Osteoporosis management in older patients who experienced a fracture. Clin Interv Aging. 2016 Aug 22;11:1111-6. doi: 10.2147/CIA.S107720. eCollection 2016.
- Results publication: PubMed 32302028Berry SD, Daiello LA, Lee Y, Zullo AR, Wright NC, Curtis JR, Kiel DP. Secular Trends in the Incidence of Hip Fracture Among Nursing Home Residents. J Bone Miner Res. 2020 Sep;35(9):1668-1675. doi: 10.1002/jbmr.4032. Epub 2020 May 8.
- Results publication: PubMed 39476530Berner JE, Ortiz-Llorens M, Fries CA, Nanchahal J, Jain A; QUINTET Collaborative. Quality of Life after Open Extremity Trauma (QUINTET) study: An international, multicentric, observational, cohort study of quality of life following lower extremity open fractures. J Plast Reconstr Aesthet Surg. 2024 Dec;99:486-493. doi: 10.1016/j.bjps.2024.10.025. Epub 2024 Oct 16.
- Results publication: PubMed 27093957Tarride JE, Burke N, Leslie WD, Morin SN, Adachi JD, Papaioannou A, Bessette L, Brown JP, Pericleous L, Muratov S, Hopkins RB. Loss of health related quality of life following low-trauma fractures in the elderly. BMC Geriatr. 2016 Apr 19;16:84. doi: 10.1186/s12877-016-0259-5.
- Results publication: PubMed 40056731Larsen P, Elsoe R. Long-term effect of lower limb fractures A national register-based cohort study with a mean of 16.7 years follow-up. Injury. 2025 Apr;56(4):112239. doi: 10.1016/j.injury.2025.112239. Epub 2025 Mar 4.
- Individual participant dataSharing planned: No. This study uses medical data involving patients' personal information, and making it public may violate patients' privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture Lower Leg and Fracture Dislocation of Upper Limb Joint, run by Shanghai 6th People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiachen Wu (+86 15250601676, dqsj7010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: From enrollment to the end of data collection at 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147504, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.