Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorVanderbilt University Medical Center
About this trial
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
Qualifiers
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
Disqualifiers
Diagnosis of pre-existing neuropathy
Untreated hypo/hyperthyroidism
Untreated heart disease
Alanine transaminase/aspartate transaminase >2x upper-limit of normal range
Trial design
Treatments tested in this trial
- GlyNAC (combination of glycine and n-acetylcysteine)
- Placebo
Treatment groups
148 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov