Recruiting

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

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06083480

Conditions

Osteoarthritis, Knee

Total Knee Arthroplasty

Chronic Postsurgical Pain

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

GlyNAC (combination of glycine and n-acetylcysteine)

Placebo

Study Details

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).

Conditions

Osteoarthritis, Knee

Total Knee Arthroplasty

Chronic Postsurgical Pain

Study ID

NCT06083480

Start date

Dec 6, 2024

Status verified date

Dec, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not 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

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: GlyNAC (combination of glycine and n-acetylcysteine)

GlyNAC 200 mg/kg/day (100mg glycine and 100mg N-acetyl-cysteine) will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively. The preparation will be a commercially available product of 1:1 ratio of glycine and N-acetyl-cysteine.

placebo comparator: Placebo (alanine)

Placebo (alanine) 200 mg/kg/day will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively.

Interventions

GlyNAC (combination of glycine and n-acetylcysteine)

Placebo

Placebo (alanine) 200 mg/kg/day will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively.

Primary outcome measure

Numeric Rating Scale (NRS) Rating of Worst Pain in the past 24 hours [ Time Frame: Baseline to 6 months post TKA (approximately 7 months) ]

Central Contacts and Locations

Central contacts

Stephen Bruehl, Ph.D.

(615) 936-1821 stephen.bruehl@vumc.org

Gail Mayo, RN

615-936-1705 gail.mayo@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-12-11.