NCT06083480 Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
| NCT ID | NCT06083480 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Osteoarthritis, Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2028-09 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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 Criteria
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 f