Actively Recruiting
Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Led by Vanderbilt University Medical Center · Updated on 2025-12-11
148
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 or older
- Intact cognitive status and ability to provide informed consent
- Ability to read and write in English sufficiently to complete study questionnaires
- Undergoing unilateral primary total knee arthroplasty
- Medical diagnosis of osteoarthritis
- Worst pain rating of at least 4 out of 10 in the past 24 hours
You will not qualify if you...
- Diagnosis of pre-existing neuropathy
- Untreated hypo- or hyperthyroidism
- Untreated heart disease
- Alanine transaminase or aspartate transaminase levels more than twice the upper normal limit
- Serum creatinine over 1.5 mg/dl
- Pregnancy
- Diagnosis of Complex Regional Pain Syndrome before TKA
- Presence of lower extremity vascular disease, inflammatory or autoimmune disorders, or cancer
- Current significant chronic pain outside of the lower extremity lasting over 3 months with intensity 3 or higher
- Other medical conditions that orthopedic surgeons believe make participation unsafe
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
S
Stephen Bruehl, Ph.D.
CONTACT
G
Gail Mayo, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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