[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653193":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":57,"studyPopulation":51,"armGroups":58,"interventions":64,"overallOfficials":51,"centralContacts":51,"locations":70,"responsibleParty":87,"collaborators":51,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":51,"enrollmentInfo":98,"targetDuration":51,"studyType":101,"phases":102,"briefSummary":103,"conditions":104,"keywords":51,"overallStatus":106,"whyStopped":51,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":51},[9],{"measure":10,"description":11,"timeFrame":12},"Patients nutritional status","The primary outcome measure is the prevalence of patients with a low Prognostic Nutritional Index (PNI) (PNI \\\u003C 40).\n\nPNI value ≥ 50: Normal; PNI value \\\u003C 50: Mild malnutrition; PNI value\\\u003C 45: Moderate to severe malnutrition; PNI value\\\u003C 40: Serious malnutrition.","At baseline and 1 month follow-up.",[14,18,21,24,26,28,30,32,34,37,40,42,44,46,48],{"measure":15,"description":16,"timeFrame":17},"Change from Baseline in Prognostic Nutritional Index (PNI) at 1 Month","Measured with Prognostic Nutritional Index (PNI), PNI value ≥ 50: Normal; PNI value \\\u003C 50: Mild malnutrition; PNI value\\\u003C 45: Moderate to severe malnutrition; PNI value\\\u003C 40: Serious malnutrition.","At baseline and 1 month follow-up",{"measure":19,"description":20,"timeFrame":17},"Change in biologicals parameters","Changes in biological parameters, including complete blood count (CBC).",{"measure":22,"description":23,"timeFrame":17},"Change in biologicals parameters (ionogram)","Changes in biological parameters, including Ionogram (sodium, potassium, chlorides, bicarbonates , unit : mmol\u002FL)",{"measure":19,"description":25,"timeFrame":17},"Changes in biological parameters, including serum albumin",{"measure":19,"description":27,"timeFrame":17},"Changes in biological parameters, including alanine aminotransferase (ALT), aspartate aminotransferase (AST)",{"measure":19,"description":29,"timeFrame":17},"Changes in biological parameters, serum creatinine, C-reactive protein (CRP), and Creatine phosphokinase (CPK)",{"measure":19,"description":31,"timeFrame":17},"Changes in biological parameters, including serum ferritin and transferrin saturation (TSAT)",{"measure":19,"description":33,"timeFrame":17},"Changes in biological parameters, including vitamins B9, B12, and D.",{"measure":35,"description":36,"timeFrame":17},"Malnutrition","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.",{"measure":38,"description":39,"timeFrame":17},"Muscular and functional performance","Handgrip strength, measured in kilograms (kg) using a hand dynamometer.",{"measure":38,"description":41,"timeFrame":17},"Calf circumference of the non-operated leg, measured in centimeters (cm).",{"measure":38,"description":43,"timeFrame":17},"Walking speed over 4 metres, measured in m\u002Fs.",{"measure":38,"description":45,"timeFrame":17},"Time required to complete five chair stands measured in seconds.",{"measure":38,"description":47,"timeFrame":17},"Time required to complete the Timed Up and Go (TUG) test, measured in seconds.",{"measure":49,"description":50,"timeFrame":17},"Pain with VAS","Pain is assessed by a Visual Analogic scale graduated from 0 to 10 (0 = no pain, 10 = the worst pain imaginable)",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":6,"observationalModel":51,"timePerspective":51,"maskingInfo":55},"NA","SINGLE_GROUP",{"masking":56,"maskingDescription":51,"whoMasked":51},"NONE","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).\n\nMalnutrition 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.\n\nMalnutrition 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.\n\nA 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.",[59],{"label":60,"type":61,"description":60,"interventionNames":62},"Total knee arthroscopy","EXPERIMENTAL",[63],"Diagnostic Test: Blood and physical performance tests",[65],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":51},"DIAGNOSTIC_TEST","Blood 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.",[60],[71],{"facility":72,"status":51,"city":73,"state":51,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Clinique des Maussins","Paris","75850","France","FR",{"type":78,"coordinates":79},"Point",[80,81],2.3488,48.85341,{"lat":81,"lon":80},[84],{"name":85,"role":86,"phone":51,"phoneExt":51,"email":51},"Geoffroy NOURISSAT, Dr","CONTACT",{"type":88,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100653193","assessment-of-the-nutritional-status-of-patients-undergoing-prosthetic-orthopedic-surgery-an-exploratory-study-100653193",false,"NCT07782502","Assessment of the Nutritional Status of Patients Undergoing Prosthetic Orthopedic Surgery: An Exploratory Study","ORTHONUTRI","Inclusion Criteria:\n\n* Male or female patients aged ≥18 years at the time of surgery\n* Patients scheduled for total knee arthroplasty.\n* Patients enrolled in the preoperative Enhanced Recovery After Surgery (ERAS) pathway.\n* Patients affiliated with or covered by a social security system.\n* French-speaking patients who have provided written informed consent\n\nExclusion Criteria:\n\n* Patients scheduled for revision total knee arthroplasty\n* Protected patients: adults under guardianship, curatorship, or other legal protection measures, or individuals deprived of liberty by judicial or administrative decision\n* Patients hospitalized without consent.","ALL","18 Years",{"count":99,"type":100},60,"ESTIMATED","INTERVENTIONAL",[53],"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.\n\nThis study is based on the hypothesis that prosthetic orthopedic surgery may induce or worsen malnutrition, an issue that has not been investigated to date.\n\nParticipants will perform an additionnal blood test, physical performance tests and questionnaires as part of this research.",[105],"Total Knee Anthroplasty","NOT_YET_RECRUITING","2026-08-19",{"date":109,"type":110},"2026-08-24","ACTUAL",{"date":112,"type":100},"2026-09-01",{"date":114,"type":100},"2028-03-31",{"name":5,"class":6},1]