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Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
RECRUITINGPhase 4Sponsored by Vanderbilt University Medical Center
Actively Recruiting
PhasePhase 4
SponsorVanderbilt University Medical Center
Started2024-12-06
Est. completion2028-09
Eligibility
Age50 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06083480
Summary
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).
Eligibility
Age: 50 Years+Healthy volunteers accepted
Inclusion Criteria: * Age 50 or older * Intact cognitive status and ability to provide informed consent (based on cognitive screening with the Mini Mental State Examination) * Ability to read and write in English sufficiently to understand and complete study questionnaires * Undergoing unilateral primary TKA * Medical diagnosis of osteoarthritis * Past 24 hour worst numeric rating scale (NRS) pain of at least 4/10. Exclusion Criteria: * Diagnosis of pre-existing neuropathy * Untreated hypo/hyperthyroidism * Untreated heart disease * Alanine transaminase/aspartate transaminase \>2x upper-limit of normal range * serum creatinine \>1.5 mg/dl * Pregnancy * Complex Regional Pain Syndrome (CRPS) diagnosis prior to undergoing TKA * Presence of lower extremity vascular disease, inflammatory or autoimmune disorders, or malignancy * Presence of current clinically significant chronic pain conditions outside of the lower extremity ( daily pain for \>3 months and greater ≥3/10 in intensity or the focus of medical care) * Presence of other medical conditions that in the opinion of the orthopedic surgeon co-investigators would make a patient's study participation unsafe
Conditions4
ArthritisChronic Postsurgical PainOsteoarthritis, KneeTotal Knee Arthroplasty
Locations1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Stephen Bruehl, PhD
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Actively Recruiting
PhasePhase 4
SponsorVanderbilt University Medical Center
Started2024-12-06
Est. completion2028-09
Eligibility
Age50 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06083480