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

Last updated: December 6, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Chronic Pain

Pain

Knee Replacement

Treatment

GlyNAC (combination of glycine and n-acetylcysteine)

Placebo

Clinical Study ID

NCT06083480
231668
1R01AG085287-01
  • Ages > 50
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age 50 or older

  • Intact cognitive status and ability to provide informed consent (based on cognitivescreening with the Mini Mental State Examination)

  • Ability to read and write in English sufficiently to understand and complete studyquestionnaires

  • Undergoing unilateral primary TKA

  • Medical diagnosis of osteoarthritis

  • Past 24 hour worst numeric rating scale (NRS) pain of at least 4/10.

Exclusion

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 thelower extremity ( daily pain for >3 months and greater ≥3/10 in intensity or thefocus of medical care)

  • Presence of other medical conditions that in the opinion of the orthopedic surgeonco-investigators would make a patient's study participation unsafe

Study Design

Total Participants: 148
Treatment Group(s): 2
Primary Treatment: GlyNAC (combination of glycine and n-acetylcysteine)
Phase: 4
Study Start date:
December 06, 2024
Estimated Completion Date:
March 31, 2029

Study Description

One of the most common surgical procedures performed in older adults is total knee arthroplasty (TKA), with an estimated 1 million TKAs performed annually in the United States. TKA directly addresses the pathology underlying knee joint pain and mobility limitations resulting from osteoarthritis. For most patients, TKA is effective for pain reduction and increasing function. However, a subgroup of 15-20% of TKA patients report unsatisfactory long-term pain outcomes well after postsurgical healing has occurred despite technical success of the procedure. Chronic postsurgical pain (CPSP) following TKA has been reported to be worse than the preoperative pain in 7% of TKA patients at up to 4-years. A potential biological mechanism is perioperative oxidative stress (OS),

The proposed project seeks to confirm the mechanistic role of OS in post-TKA CPSP and test the hypothesis that a perioperative intervention to reduce OS may reduce risk for CPSP post-TKA. 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 (GlyNAC) reduces OS and CPSP in patients undergoing total knee arthroplasty (TKA).

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Active - Recruiting

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