[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04210284":3,"trial-entities:NCT04210284":90,"trial-summary:NCT04210284":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":48,"locations":51,"central_contacts":81,"overall_officials":84,"references":88,"see_also_links":89},"NCT04210284","18-01976","Oral Nutritional Optimization in Total Joint Arthroplasty","RECRUITING","2027-06-30","2025-09","2025-09-11","2021-07-06","NYU Langone Health","OTHER",true,"The purpose of this study is to determine the effect on hematological markers of nutritional intervention on nutritionally deficient patients following total joint replacement surgery.","Numerous pre-operative modifiable variables have been extensively investigated for their effect on outcomes in TJA. These include metabolic diseases such as diabetes mellitus, obesity, and smoking status. However, nutritional status has not been as thoroughly investigated; to date, no prospective randomized control study has assessed the effect of oral nutritional supplementation for malnourished patients. This study will be a novel investigation into the role for routine serum screening for malnutrition as well as oral nutritional supplementation in TJA patients. This study could serve as a stepping stone towards creating a new pathway to highlight at-risk patients and pre-operatively optimizing their outcomes after TJA.",[18],"Osteoarthritis",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},72,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DIETARY_SUPPLEMENT","Ensure","Ensure Max Protein Shake is an over the counter available drinkable nutritional supplement. Per serving, it contains:\n\n* 160 Calories, 20 from fat\n* 2g Total fat\n* 0.5g Saturated fat\n* 20mg Cholesterol\n* 135mg Sodium\n* 170mg Potassium\n* 19g Total carbohydrate\n* \\\u003C1g Fiber\n* 4g Sugar\n* 16g Protein\n\nParticipants will receive Ensure High Protein for 2 weeks pre- and 4 weeks post-operatively. These patients will be instructed to consume 1 serving (16fl oz) of Ensure High Protein daily. They will be provided with this product at a pre-operative clinical visit or have it mailed to their home. Hematologic nutritional values will be measured as specified previously.\n\nDescriptive statistics will be used to report baseline characteristics and primary study objectives. Hematologic outcomes will be compared between the control (\"NO ENSURE\") and oral supplementation (\"ENSURE\") arms for the aforementioned baseline and perioperative variables",[33],"Nutritional supplementation",[35],{"measure":36,"description":37,"timeFrame":38},"Changes in the patients' albumin, pre-albumin, and\u002For transferrin levels","Biological specimen collection and laboratory evaluations- all included patients' hematologic markers of malnutrition (albumin, pre-albumin, and transferrin) will be recorded at 2 weeks prior to surgery, the day of surgery, and 6 weeks. These blood tests can all be performed from one sample of blood at each visit. The results will then be accessed via the EMR","Visit 2 (2 wks pre) Visit 3 (surgery day) Visit 5 (4 weeks post)",[],"ALL","55 Years",null,false,{"inclusion":45,"exclusion":46,"raw_text":47},[],[],"Inclusion Criteria:\n\n1. Patient are current candidates for elective primary total hip and total knee arthroplasty\n2. Patients ≥55 years of age but ≤ 95\n3. Patients who meet at least one of the following three laboratory criteria for malnutrition:\n\nTSerum Albumin: ≤3.5 mg\u002Fdl Pre-Albumin: \\\u003C15 mg\u002Fdl Transferrin: \\\u003C200 mg\u002Fdl\n\nExclusion Criteria:\n\n1. Previous history of septic arthritis\n2. Allergy to oral supplementation\n3. Inability to consume oral supplementation\n4. Protein malabsorption syndromes\n5. Eating disorders\n6. End stage renal and hepatic disease\n7. Revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty",[49,50],"ADULT","OLDER_ADULT",[52,68],{"facility":12,"status":7,"city":53,"state":53,"zip":54,"country":55,"contacts":56,"geoPoint":65},"New York","10016","United States",[57,62],{"name":58,"role":59,"phone":60,"email":61},"Daniel Waren","CONTACT","212-598-6245","daniel.waren@nyulangone.org",{"name":63,"role":64},"Ran Schwarzkopf, MD","PRINCIPAL_INVESTIGATOR",{"lat":66,"lon":67},40.71427,-74.00597,{"facility":69,"status":7,"city":70,"state":71,"zip":72,"country":55,"contacts":73,"geoPoint":78},"Rothman Orthopedic Institute","Philadelphia","Pennsylvania","19107",[74],{"name":75,"role":59,"phone":76,"email":77},"Alicia Reyes","267-339-3627","Alicia.Reyes@rothmanortho.com",{"lat":79,"lon":80},39.95238,-75.16362,[82],{"name":58,"role":59,"phone":60,"email":83},"Daniel.waren@nyulangone.org",[85],{"name":86,"affiliation":87,"role":64},"Ran Schwarzkopf","NYU Langone",[],[],{"nct_id":4,"conditions":91,"biomarkers":92},[18],[],{"nct_id":4,"found":14,"summary":94,"prompt_version":103},{"design":95,"status":96,"heading":6,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an interventional study planning to enroll 72 participants. The study aims to investigate the effect of oral nutritional supplementation.","completed","This study is looking at how nutritional support might help patients having total hip or knee replacement surgery for osteoarthritis. Researchers want to see if giving patients a nutritional drink called Ensure Max Protein Shake before and after surgery can improve their nutritional status. You might be able to join if you are 55 to 95 years old, are scheduled for a total hip or knee replacement, and have certain low levels of proteins in your blood (albumin, pre-albumin, or transferrin), which can indicate malnutrition. The study will measure these protein levels to see if the nutritional drink makes a difference. The study is currently unclear on its recruitment status and plans to enroll 72 participants.","Participants will be followed for at least four weeks after surgery, based on the primary endpoint measurements.",116,"You would have blood tests to measure your albumin, pre-albumin, and\u002For transferrin levels at two weeks before surgery, on the day of surgery, and four weeks after surgery.","Not stated in the trial record.",[30],"v2"]