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

NCT06083480 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-12-11

No results posted yet for this 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).

Conditions

  • Osteoarthritis, Knee
  • Total Knee Arthroplasty
  • Chronic Postsurgical Pain

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

Principal Investigators

  • Stephen Bruehl, Ph.D. · Vanderbilt University Medical Center

  • Frederic T Billings, IV, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-06
Primary Completion
2028-09-30
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06083480 on ClinicalTrials.gov