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Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty

StatusRecruiting
PhasePhase 4
Started2024-12-06
View on ClinicalTrials.gov ↗

Amendment history

2025-12-05
minor
Study Status, Oversight v7
Re-verified, no change to tracked fields
2024-12-06
minor
Study Status v6
Start dateestimated 2024-12→confirmed 2024-12-06
2024-12-04
notable
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start date2024-11-15→2024-12
Study sitesdetails revised at 1 of 1 site
2024-10-03
minor
Study Status, Oversight v4
Start date2024-09-02→2024-11-15
2024-07-08
minor
Study Status v3
Start date2024-06-15→2024-09-02
Show 2 earlier versions
2024-04-29
minor
Study Status v2
Start date2024-03→2024-06-15
2023-11-15
minor
Study Identification, Study Status, Outcome Measures v1
Secondary endpoints6 to 10 entries
Postsurgical Opioid Use (pill count) Postsurgical Opioid Use (days of opioid use in the past week) F2-Isoprostane/Isofuran (IsoP/IsoF) levels Glutathione levels
2023-10-10
minor
Original filing
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).
Trial Details
NCT Number NCT06083480
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute on Aging (NIA)
Conditions Osteoarthritis, Knee, Total Knee Arthroplasty, Chronic Postsurgical Pain
Enrollment 148 participants
Start Date 2024-12-06
Primary Completion 2028-09 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-11