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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether a special combination of antioxidants, called glycine and N-acetyl-cysteine (GlyNAC), can help reduce pain and improve recovery for people undergoing total knee replacement surgery due to osteoarthritis. The researchers want to see if taking these antioxidants before and after the surgery can lower a harmful process in the body known as oxidative stress, which might lead to chronic pain after the operation. The study will follow participants for a year to measure their pain levels and how well they function.

To participate in this trial, you need to be 50 years or older, have a diagnosis of osteoarthritis, and be planning to have a single knee replacement surgery. You should also be able to understand and fill out study questionnaires in English. However, if you have certain medical conditions, like untreated heart disease or other serious health issues, you may not be eligible. If you join the study, you can expect close monitoring and support from the research team to help you through the process.

Gender

ALL

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 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