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NCT06083480 | NOT YET RECRUITING | Osteoarthritis, Knee

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

Vanderbilt University Medical Center

Information provided by (Responsible Party):

Stephen Bruehl, PhD

Brief 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).

Condition or disease

Osteoarthritis, Knee

Total Knee Arthroplasty

Chronic Postsurgical Pain

Intervention/treatment

GlyNAC (combination of glycine and n-acetylcysteine)

Placebo

Phase

PHASE4

Detailed 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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 148 participants
Masking : QUADRUPLE
Primary Purpose : PREVENTION
Official Title : Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Actual Study Start Date : 2024-09-02
Estimated Primary Completion Date : 2028-09
Estimated Study Completion Date : 2029-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty

Location Details

NCT06083480

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Locations

Not yet recruiting

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212