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

RECRUITINGPhase 4Sponsored by Vanderbilt University Medical Center
Actively Recruiting
PhasePhase 4
SponsorVanderbilt University Medical Center
Started2024-12-06
Est. completion2028-09
Eligibility
Age50 Years+
Healthy vol.Accepted
Locations1 site

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).

Eligibility

Age: 50 Years+Healthy volunteers accepted
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

Conditions4

ArthritisChronic Postsurgical PainOsteoarthritis, KneeTotal Knee Arthroplasty

Locations1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Stephen Bruehl, PhD

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