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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 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 578-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06083480
The ClinicalTrials.gov registry entry for NCT06083480 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 578-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (74% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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 Postsurgical 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.
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