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NCT Number: NCT07782502

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

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.

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Key information

Conditions

Total Knee Anthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique des Maussins

Paris, 75850, France

Location contact

Geoffroy NOURISSAT, Dr

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Patients nutritional status

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Change in biologicals parameters

    Time frame: At baseline and 1 month follow-up

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

  3. Change in biologicals parameters (ionogram)

    Time frame: At baseline and 1 month follow-up

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

  4. Change in biologicals parameters

    Time frame: At baseline and 1 month follow-up

    Changes in biological parameters, including serum albumin

  5. Change in biologicals parameters

    Time frame: At baseline and 1 month follow-up

    Changes in biological parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST)

  6. Change in biologicals parameters

    Time frame: At baseline and 1 month follow-up

    Changes in biological parameters, serum creatinine, C-reactive protein (CRP), and Creatine phosphokinase (CPK)

  7. Change in biologicals parameters

    Time frame: At baseline and 1 month follow-up

    Changes in biological parameters, including serum ferritin and transferrin saturation (TSAT)

  8. Change in biologicals parameters

    Time frame: At baseline and 1 month follow-up

    Changes in biological parameters, including vitamins B9, B12, and D.

  9. Malnutrition

    Time frame: 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.

  10. Muscular and functional performance

    Time frame: At baseline and 1 month follow-up

    Handgrip strength, measured in kilograms (kg) using a hand dynamometer.

  11. Muscular and functional performance

    Time frame: At baseline and 1 month follow-up

    Calf circumference of the non-operated leg, measured in centimeters (cm).

  12. Muscular and functional performance

    Time frame: At baseline and 1 month follow-up

    Walking speed over 4 metres, measured in m/s.

  13. Muscular and functional performance

    Time frame: At baseline and 1 month follow-up

    Time required to complete five chair stands measured in seconds.

  14. Muscular and functional performance

    Time frame: At baseline and 1 month follow-up

    Time required to complete the Timed Up and Go (TUG) test, measured in seconds.

  15. Pain with VAS

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ORTHONUTRI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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