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NCT06083480 · ClinicalTrials.gov registry record · Phase 4
Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
A Phase 4 study of Osteoarthritis, Knee and Total Knee Arthroplasty, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 148
- Enrollment target
- 1
- Study location
NCT06083480: Recruiting Phase 4 study of Osteoarthritis, Knee and Total Knee Arthroplasty, sponsored by Vanderbilt University Medical Center.
NCT06083480 is a Phase 4 study of Osteoarthritis, Knee and Total Knee Arthroplasty that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 148 participants, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06083480, a Phase 4 study of Osteoarthritis, Knee and Total Knee Arthroplasty, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 148 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Mean within participant changes in NRS intensity ratings of worst pain in past 24 hours of measurement at 6 months post TKA. The score is a rating of current acute pain using a 0-100 numeric rating scale (NRS) (0 = "no pain" and 100 = "worst possible pain").
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GlyNAC (combination of glycine and n-acetylcysteine)
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2024-12-06 |
| Est. Completion | 2029-03 |
| Phase | Phase 4 |
What NCT06083480 shows while recruiting
NCT06083480 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (70% lower).
The record links to 3 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06083480 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06083480 about?
NCT06083480 is a clinical study titled "Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty". 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 oxida...
What is the current status of trial NCT06083480?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 148 participants. The study started on 2024-12-06. Estimated completion is 2029-03.
What conditions does trial NCT06083480 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Total Knee Arthroplasty, Chronic Post Surgical Pain.
What interventions are being tested in trial NCT06083480?
The interventions under investigation include: Placebo (DRUG), GlyNAC (combination of glycine and n-acetylcysteine) (DRUG).
Who is sponsoring clinical trial NCT06083480?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06083480 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06083480's enrollment target sits among peer trials
148 48th of 112 higher than 65 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Triamcinolone Ketorolac (TriKe) Knee Trial
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Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes
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ZYNRELEF for Pain Management in Total Knee Arthroplasty
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Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
ACTIVE NOT RECRUITING · Phase 4
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Corticosteroid Meniscectomy Randomized Trial
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Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)
ACTIVE NOT RECRUITING · Phase 4
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