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

NCT07159945 | Completed

• 1 other identifier: MTCA,ECFAH Of FMU [2015]084 -2
• Study Type: observational
• Target: 1,296
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intertrochanteric Fractures; Internal fixation failure; CONUT score; Nomogram model; Nutritional Status

Outcome Measures

Primary Outcomes (3)

• The CONUT score

  Before surgery

• The PNI score

  Before surgery

• The NPS score

  Before surgery

Secondary Outcomes (6)

• serum albumin

  Before surgery

• total cholesterol

  Before surgery

• lymphocyte count

  Before surgery

• fracture type

  Before surgery

• age

  Before surgery

Study Arms (2)

FIF-ITF group

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to inclusion criteria, 1,296 patients undergoing internal fixation for intertrochanteric fractures at the aforementioned medical institutions between 2020 and 2024 were selected. All patients completed at least one year of follow-up. Follow-up comprised comprehensive orthopaedic examinations and serological tests, supplemented by repeat imaging where necessary to assess local fracture/internal fixation status.

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Liu Zhang, MD

  First Affiliated Hospital of Fujian Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: January 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

CN (1)