Assessment of the Nutritional Status of Patients Undergoing Prosthetic Orthopedic Surgery: An Exploratory Study

N/ANot Yet RecruitingNCT07782502

GCS Ramsay Santé pour l'Enseignement et la Recherche60 enrolled

Overview

The aim of this study is to evaluate the impact of prosthetic orthopedic surgery on the nutritional status of patients undergoing total knee arthroplasty in adult patients scheduled. This study is based on the hypothesis that prosthetic orthopedic surgery may induce or worsen malnutrition, an issue that has not been investigated to date. Participants will perform an additionnal blood test, physical performance tests and questionnaires as part of this research.

Prosthetic joint surgery is now a major public health issue in France. According to data published by the French National Academy of Medicine, approximately 305,780 major joint arthroplasties were performed in 2017, representing a 39% increase over a ten-year period (219,826 procedures in 2006). Malnutrition is common among patients undergoing major orthopedic surgery, with a reported prevalence of up to 50%, depending on the study population. Preoperative malnutrition has been associated with an increased risk of intraoperative events and postoperative complications. Malnutrition is a modifiable biological risk factor. Optimizing nutritional status before total joint arthroplasty may improve the overall value of care while reducing the risk of intraoperative and postoperative complications. A composite index combining serum albumin concentration and total lymphocyte count, the Prognostic Nutritional Index (PNI), has been developed to assess nutritional status. Among patients undergoing total knee arthroplasty, better perioperative nutritional status has been associated with improved clinical and functional outcomes, including reduced pain, better patient-reported outcome measures (PROMs), and improved knee biomechanics. These benefits have been shown to persist for more than one year after surgery. If many studies focus on the patient's nutritional status prior to surgery, very few have examined the impact of surgery on post-operative nutritional outcomes.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patients aged ≥18 years at the time of surgery * Patients scheduled for total knee arthroplasty. * Patients enrolled in the preoperative Enhanced Recovery After Surgery (ERAS) pathway. * Patients affiliated with or covered by a social security system. * French-speaking patients who have provided written informed consent Exclusion Criteria: * Patients scheduled for revision total knee arthroplasty * Protected patients: adults under guardianship, curatorship, or other legal protection measures, or individuals deprived of liberty by judicial or administrative decision * Patients hospitalized without consent.

Outcomes

Primary Outcomes

Patients nutritional status

The primary outcome measure is the prevalence of patients with a low Prognostic Nutritional Index (PNI) (PNI \< 40). PNI value ≥ 50: Normal; PNI value \< 50: Mild malnutrition; PNI value\< 45: Moderate to severe malnutrition; PNI value\< 40: Serious malnutrition.

Time frame: At baseline and 1 month follow-up.

Secondary Outcomes

Change from Baseline in Prognostic Nutritional Index (PNI) at 1 Month

Measured with Prognostic Nutritional Index (PNI), PNI value ≥ 50: Normal; PNI value \< 50: Mild malnutrition; PNI value\< 45: Moderate to severe malnutrition; PNI value\< 40: Serious malnutrition.