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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05814172
Other study ID # TREC2023-KY026
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date November 2023

Study information

Verified date March 2023
Source Beijing Tongren Hospital
Contact YING CHEN
Phone 008613621247560
Email trchenying@mail.ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hip fracture has a serious impact on the quality of life and even the survival of older adults. The multidisciplinary management of hip fracture has been shown to be effective in improving patient outcome and cost-effective in international studies. As geriatricians and members of a multi-disciplinary team(MDT), we are aware of various scores in predicting the 1-year mortality risk in hospitalized older adults with multimorbidity. However, given the need for a deeper understanding of the preoperative status of elderly patients who were suffering from pain, tension, anxiety, delirium,etc., we hope to explore a simple, quick, objective, and accurate method for assessing the status of elderly patients with hip fractures to predict their survival risk.


Description:

This was a single-center retrospective cohort study which were approved by the Clinical Research Ethics Committee of Beijing Tongren Hospital, Capital Medical University (TREC2023-KY026). Demographic characteristics and medical parameters, such as age, gender, body mass index (BMI), comorbidities, hemoglobin , lymphocytes, C-reactive protein (CRP), fasting blood glucose, creatinine, total protein, albumin, triglycerides, total cholesterol and American Association of Anesthesiologists (ASA) were collected from the electronic medical record system. Controlling nutritional status (CONUT) was calculated from 3 variables: serum albumin concentration, total cholesterol concentration, and lymphocyte count, as previously reported. All enrolled patients were followed-up in an outpatients setting. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. The follow-up lasted for one year and the last follow-up was ended on December 31, 2022. All analyses were performed using SPSS version 19.0 (SPSS, Chicago, IL, USA).


Recruitment information / eligibility

Status Recruiting
Enrollment 303
Est. completion date November 2023
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years to 110 Years
Eligibility Inclusion Criteria: 1. patients aged ?65 years old; 2. patients diagnosed with hip fracture, including femoral neck fracture, femoral intertrochanteric fracture, and femoral subtrochanteric fracture; 3. patients whose injury was within 21 days of presentation. Exclusion Criteria: 1. patients aged <65 years old; 2. patients with pathological fractures due to tumor metastasis or infection or inherited bone disorder; 3. patients with avascular necrosis of femoral head; 4. patients with periprosthetic fractures; 5. old fracture patients treated more than 21 days from injury; 6. patients with severe trauma or fracture in other parts; 7. patients and their families who could not bear the surgical risk and are unwilling to receive surgical treatment; 8. patients died in hospital.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
China Beijing Tongren Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality After discharge, all enrolled patients were followed-up in an outpatients setting. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. Survival data were obtained via direct contact with patients or patients' caregiver by their physicians at the hospital , or via telephone interview of their family by dedicated coordinators and investigators. Outcomes were recorded. Calculated from the time of discharge, each patient was followed up 1 year, all-cause death in 1 year after discharge was counted.
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