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

Completed

• Conditions: Intertrochanteric Fractures; Internal Fixation Failure; Nutritional Status; CONUT Score; Nomogram Model

• Registration Number: NCT07159945
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2025-08
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-08-29
• Last Update Submitted: 2025-08-29
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1296

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The CONUT score	Before surgery
The PNI score	Before surgery
The NPS score	Before surgery

Secondary Outcome Measures

Name	Time	Method
serum albumin	Before surgery
fracture type	Before surgery
total cholesterol	Before surgery
lymphocyte count	Before surgery
age	Before surgery
osteoporosis	Before surgery

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China