Home › Knee Osteoarthritis › NCT06083480
Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
RecruitingPhase 4
Who can join
Ages 50 and older · All sexes
Full 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 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
About the study
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).
What is being tested
- GlyNAC (combination of glycine and n-acetylcysteine) (drug)
- Placebo (drug)
Sponsor: Vanderbilt University Medical Center · Participants: 148 · Started: Dec 6, 2024
Contact the study team
- Stephen Bruehl, Ph.D. · Phone: (615) 936-1821
- Gail Mayo, RN · Phone: 615-936-1705
Official record on ClinicalTrials.gov — NCT06083480
Locations in the U.S.
| Tennessee | Vanderbilt University Medical Center, Nashville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.