Total Knee Anthroplasty
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTBlood and physical performance tests
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.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients nutritional status | At baseline and 1 month follow-up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Prognostic Nutritional Index (PNI) at 1 Month | At baseline and 1 month follow-up | 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. |
| Change in biologicals parameters | At baseline and 1 month follow-up | Changes in biological parameters, including complete blood count (CBC). |
| Change in biologicals parameters (ionogram) | At baseline and 1 month follow-up | Changes in biological parameters, including Ionogram (sodium, potassium, chlorides, bicarbonates , unit : mmol/L) |
| Malnutrition | At baseline and 1 month follow-up | The Mini Nutritional Assessment (Short Form) consists of six items assessing food intake, recent weight loss, mobility, acute disease or psychological stress, neuropsychological problems, and body mass index (BMI) or, when BMI cannot be calculated, calf circumference. The total score ranges from 0 to 14, with 12-14 indicating normal nutritional status, 8-11 indicating risk of malnutrition, and 0-7 indicating malnutrition. |
| Muscular and functional performance | At baseline and 1 month follow-up | Handgrip strength, measured in kilograms (kg) using a hand dynamometer. |
| Pain with VAS | At baseline and 1 month follow-up | Pain is assessed by a Visual Analogic scale graduated from 0 to 10 (0 = no pain, 10 = the worst pain imaginable) |
Countries
France
Outcome results
None listed