Health TrialsbyHealthPanel

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

ConditionTotal Knee Anthroplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood and physical performance tests

    Diagnostic test

    Additional postoperative blood tests. Physical performance test (hand grip-test, measurement of the calf circumference of the non-operated leg, walking test, chair stand test and Timed Up \& Go test.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Total knee arthroscopyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.

Time frame
At baseline and 1 month follow-up
2

Change in biologicals parameters

Changes in biological parameters, including complete blood count (CBC).

Time frame
At baseline and 1 month follow-up
3

Change in biologicals parameters (ionogram)

Changes in biological parameters, including Ionogram (sodium, potassium, chlorides, bicarbonates , unit : mmol/L)

Time frame
At baseline and 1 month follow-up
4

Change in biologicals parameters

Changes in biological parameters, including serum albumin

Time frame
At baseline and 1 month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GCS Ramsay Santé pour l'Enseignement et la Recherche

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: