Reducing oxidative stress to prevent chronic pain after knee surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective randomized controlled trial aimed at evaluating the effects of a potent antioxidant intervention, GlyNAC, on oxidative stress and chronic postsurgical pain in patients undergoing total knee arthroplasty (TKA). The study will assess preoperative, perioperative, and long-term outcomes over a 12-month period, focusing on pain levels and functional improvements. By targeting oxidative stress, the trial seeks to determine if reducing this biological factor can lead to better pain management and recovery for TKA patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Stephen Bruehl, Ph.D. — Vanderbilt University Medical Center
• Study coordinator: Stephen Bruehl, Ph.D.
• Email: stephen.bruehl@vumc.org
• Phone: (615) 936-1821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.