Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
In plain words A Phase 4 study of glyNAC in people 50 and older, run by Vanderbilt University Medical Center. It plans to enroll about 148 people at 1 US site.
Who it lists and where
Who the trial lists, as registered
Lists people 50 and older. Conditions: Osteoarthritis, Knee; Total Knee Arthroplasty; Chronic Postsurgical Pain.
- 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
2 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
GlyNAC (combination of glycine and n-acetylcysteine); Placebo
Registered 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).
Where, as registered
1 US site in 1 state.