Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Prevention
Participants needed
148 (estimated)
Sponsor
Vanderbilt University Medical Center · Other
Who this trial is looking for
This trial is looking for people aged 50 or older who are having knee surgery due to osteoarthritis. Participants will receive a treatment that may help reduce pain after the surgery, and their progress will be checked for a year.
Are You a Good Fit for This Trial?
You may be able to join if
I am 50 years old or older.
I am having a knee surgery for the first time.
I have been diagnosed with osteoarthritis.
I have the ability to read and write in English.
I can understand and give my consent for the study.
I have experienced significant pain in the last 24 hours.
You may not be able to join if
I have a diagnosis of neuropathy.
I have untreated thyroid issues.
I have untreated heart disease.
My liver enzymes are too high.
My creatinine level is above 1.5 mg/dl.
I am pregnant.
I have a diagnosis of Complex Regional Pain Syndrome.
I have significant pain in areas other than my knee.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 (TK…
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 Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 p…
Inclusion Criteria:
* 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
* Medical diagnosis of osteoarthritis
* Past 24 hour worst numeric rating scale (NRS) pain of at least 4/10.
Exclusion Criteria:
* Diagnosis of pre-existing neuropathy
* Untreated hypo/hyperthyroidism
* Untreated heart disease
* Alanine transaminase/aspartate transaminase \>2x upper-limit of normal range
* serum creatinine \>1.5 mg/dl
* Pregnancy
* Complex Regional Pain Syndrome (CRPS) diagnosis prior to undergoing TKA
* Presence of lower extremity vascular disease, inflammatory or autoimmune disorders, or malignancy
* Presence of current clinically significant chronic pain conditions outside of the lower extremity ( daily pain for \>3 months and greater ≥3/10 in intensity or the focus of medical care)
* Presence of other medical conditions that in the opinion of the orthopedic surgeon co-investigators would make a patient's study participation unsafe
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