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Completed

NCT Number: NCT07159945

Controlling Nutritional Status as a Superior Predictor of Fixation Failure in Intertrochanteric Fractures: Development and Validation of a Multicentre Nomogram

A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. This study employed three distinct nutritional assessment tools for preoperative nutritional evaluation: CONUT, PNI, and NPS. By comparing the prevalence of malnutrition across these three scales and their relationship with FIF-ITF, an optimal predictive model combining INST with clinical factors was established.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

About this study

A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. Detailed documentation of patient information, including age, gender, affected side, bone mineral density (BMD), age-adjusted Charlson Comorbidity Index (aCCI), fracture type, internal fixation method, haematological parameters, implant-related complications (INSTs), and reasons for failure. This study employed three distinct nutritional assessment tools for preoperative nutritional evaluation: CONUT, PNI, and NPS. By comparing the prevalence of malnutrition across these three scales and their relationship with FIF-ITF, an optimal predictive model combining INST with clinical factors was established.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Diagnosis of ITF on the basis of medical history, symptoms, imaging data, etc.; 2. Treatment by internal fixation surgery; 3. Normal cognitive function; and 4. Informed consent obtained from the patient or family.

Exclusion criteria

  • 1. Significant missing data: In accordance with the Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement, only cases with complete key variables (missing rate <5%) were included; 2. Severe preoperative systemic comorbidities (e.g., decompensated liver/renal failure, active pneumonia, malignancy, and cachexia) and/or a history of mental illness; and 3. Missing postoperative follow-up.

Treatment and study plan

Primary outcomes

  1. The CONUT score

    Time frame: Before surgery

  2. The PNI score

    Time frame: Before surgery

  3. The NPS score

    Time frame: Before surgery

Secondary outcomes

  1. serum albumin

    Time frame: Before surgery

  2. total cholesterol

    Time frame: Before surgery

  3. lymphocyte count

    Time frame: Before surgery

  4. fracture type

    Time frame: Before surgery

  5. age

    Time frame: Before surgery

  6. osteoporosis

    Time frame: Before surgery

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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