[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522504":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":36,"locations":45,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":29,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":29,"enrollmentInfo":76,"targetDuration":29,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":29,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Vanderbilt University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"GlyNAC (combination of glycine and n-acetylcysteine)","EXPERIMENTAL","GlyNAC 200 mg\u002Fkg\u002Fday (100mg glycine and 100mg N-acetyl-cysteine) will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively. The preparation will be a commercially available product of 1:1 ratio of glycine and N-acetyl-cysteine.",[13],"Drug: GlyNAC (combination of glycine and n-acetylcysteine)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (alanine)","PLACEBO_COMPARATOR","Placebo (alanine) 200 mg\u002Fkg\u002Fday will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],[25],"GlyNAC",{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":29},"Placebo",[15],null,[31,34],{"name":32,"affiliation":5,"role":33},"Stephen Bruehl, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Frederic T Billings, IV, MD",[37,41],{"name":32,"role":38,"phone":39,"phoneExt":29,"email":40},"CONTACT","(615) 936-1821","stephen.bruehl@vumc.org",{"name":42,"role":38,"phone":43,"phoneExt":29,"email":44},"Gail Mayo, RN","615-936-1705","gail.mayo@vumc.org",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Nashville","Tennessee","37212","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.78444,36.16589,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":29,"phoneExt":29,"email":29},"Stephen Bruehl, PhD",{"type":33,"investigatorFullName":61,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Professor of Anethesiology",[65],{"name":66,"class":67},"National Institute on Aging (NIA)","NIH","100522504","phase-4-reducing-perioperative-oxidative-stress-to-prevent-postoperative-chronic-pain-following-total-knee-arthroplasty-100522504",false,"NCT06083480","Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty","Inclusion Criteria:\n\n* Age 50 or older\n* Intact cognitive status and ability to provide informed consent (based on cognitive screening with the Mini Mental State Examination)\n* Ability to read and write in English sufficiently to understand and complete study questionnaires\n* Undergoing unilateral primary TKA\n* Medical diagnosis of osteoarthritis\n* Past 24 hour worst numeric rating scale (NRS) pain of at least 4\u002F10.\n\nExclusion Criteria:\n\n* Diagnosis of pre-existing neuropathy\n* Untreated hypo\u002Fhyperthyroidism\n* Untreated heart disease\n* Alanine transaminase\u002Faspartate transaminase \\>2x upper-limit of normal range\n* serum creatinine \\>1.5 mg\u002Fdl\n* Pregnancy\n* Complex Regional Pain Syndrome (CRPS) diagnosis prior to undergoing TKA\n* Presence of lower extremity vascular disease, inflammatory or autoimmune disorders, or malignancy\n* Presence of current clinically significant chronic pain conditions outside of the lower extremity ( daily pain for \\>3 months and greater ≥3\u002F10 in intensity or the focus of medical care)\n* Presence of other medical conditions that in the opinion of the orthopedic surgeon co-investigators would make a patient's study participation unsafe","ALL","50 Years",{"count":77,"type":78},148,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","This is a prospective randomized controlled trial that will assess preoperative, perioperative, and long-term oxidative stress (OS); pain; and functional outcomes over a 12 month period and test the hypothesis that a potent antioxidant intervention (glycine + N-acetyl-cysteine(GlyNAC)) reduces oxidative stress and chronic post surgical pain (CPSP) in patients undergoing total knee arthroplasty (TKA).",[84,85,86],"Osteoarthritis, Knee","Total Knee Arthroplasty","Chronic Postsurgical Pain","2025-12-05",{"date":89,"type":90},"2025-12-11","ACTUAL",{"date":92,"type":90},"2024-12-06",{"date":94,"type":78},"2029-03",{"name":5,"class":6},1]