Relationship Between Mortality Rates of Fractures in Different Sites and Several Factors in Elderly Patients

NCT ID: NCT07147504

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Fracture Lower Leg Fracture Dislocation of Upper Limb Joint Spinal Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Upper limb fractures Group

No interventions assigned to this group

Lower limb fracture Group

No interventions assigned to this group

Spinal fractures Group

No interventions assigned to this group

60-64 years old Group

No interventions assigned to this group

65-69 years old Group

No interventions assigned to this group

70-74 years old Group

No interventions assigned to this group

75-79 years old Group

No interventions assigned to this group

80 years and above Group

No interventions assigned to this group

Normal nutritional status Group

No interventions assigned to this group

Malnutrition status Group

No interventions assigned to this group

Overnutrition status Group

No interventions assigned to this group

Normal metabolism Group

No interventions assigned to this group

Abnormal metabolism group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Multiple fractures;
* Conservative treatment selected;
* Incomplete medical records.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chaoyin Jiang

associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Jiachen Wu

Role: CONTACT

+86 15250601676

References

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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.

Reference Type RESULT
PMID: 30811581 (View on PubMed)

Oertel 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.

Reference Type RESULT
PMID: 27578967 (View on PubMed)

Berry 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.

Reference Type RESULT
PMID: 32302028 (View on PubMed)

Berner 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.

Reference Type RESULT
PMID: 39476530 (View on PubMed)

Tarride 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.

Reference Type RESULT
PMID: 27093957 (View on PubMed)

Larsen 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.

Reference Type RESULT
PMID: 40056731 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2025-KY-231(K)

Identifier Type: -

Identifier Source: org_study_id

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