NCT07147504

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 22, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

fractureLimb fracturesSpinal fracturesElderly peoplethe oldSurvival rate

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    From enrollment to the end of data collection at 4 months

  • Fracture-related mortality

    From enrollment to the end of data collection at 4 months

Secondary Outcomes (2)

  • Postoperative complication rate

    From enrollment to the end of data collection at 4 months

  • Recurrent fracture rate

    From enrollment to the end of data collection at 4 months

Study Arms (13)

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

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients aged 60 years and older who underwent surgical treatment for fractures

You may qualify if:

  • 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.

You may not qualify if:

  • Multiple fractures;
  • Conservative treatment selected;
  • Incomplete medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Spinal FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and Injuries

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

August 22, 2025

First Posted

August 29, 2025

Study Start

September 1, 2025

Primary Completion

October 15, 2025

Study Completion

February 28, 2026

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

This study uses medical data involving patients' personal information, and making it public may violate patients' privacy.