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Antioxidant

GlyNAC for Postoperative Pain After Knee Replacement

Phase 4

Waitlist Available

Led By Stephen Bruehl, Ph.D.

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50 or older

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 week pre-tka assessment, and 6 weeks, 6 months and 12 months post tka (13 months)

Awards & highlights

Study Summary

This trial tests if GlyNAC can reduce post-op pain & oxidative stress in knee replacement patients over 12mo.

Who is the study for?

This trial is for individuals over 50 with osteoarthritis who are experiencing significant pain and are scheduled for total knee replacement surgery. They must be able to understand and consent to the study, as well as complete questionnaires in English. People with pregnancy, vascular diseases, autoimmune disorders, cancer, neuropathy, untreated thyroid or heart conditions, certain liver or kidney issues, or other significant chronic pains are not eligible.Check my eligibility

What is being tested?

The trial is testing whether a combination of antioxidants called GlyNAC (glycine and n-acetylcysteine) can reduce oxidative stress and prevent long-term chronic pain after knee replacement surgery. Participants will receive either GlyNAC or a placebo before and after their surgery in this randomized controlled study.See study design

What are the potential side effects?

While specific side effects of GlyNAC aren't detailed here, common side effects may include gastrointestinal discomfort such as nausea or diarrhea. Antioxidants like N-acetylcysteine sometimes cause allergic reactions or skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I am mentally capable of understanding and agreeing to the trial.

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My worst pain in the last 24 hours was at least a 4 out of 10.

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I have been diagnosed with osteoarthritis.

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I am having a knee replacement surgery on one knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 week pre-tka assessment, and 6 weeks, 6 months and 12 months post tka (13 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 week pre-tka assessment, and 6 weeks, 6 months and 12 months post tka (13 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 week pre-tka assessment, and 6 weeks, 6 months and 12 months post tka (13 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

F2-Isoprostane/Isofuran (IsoP/IsoF) levels

Glutathione levels

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GlyNAC (combination of glycine and n-acetylcysteine)Experimental Treatment1 Intervention

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.

Group II: Placebo (alanine)Placebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GlyNAC (combination of glycine and n-acetylcysteine)

2014

Completed Phase 1

~20

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,668 Previous Clinical Trials

28,004,916 Total Patients Enrolled

30 Trials studying Osteoarthritis

10,008 Patients Enrolled for Osteoarthritis

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,044 Total Patients Enrolled

5 Trials studying Osteoarthritis

612 Patients Enrolled for Osteoarthritis

Stephen Bruehl, Ph.D.Principal InvestigatorVanderbilt University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned GlyNAC (glycine and n-acetylcysteine amalgamation) for clinical use?

"As the GlyNAC treatment is already approved, there exists ample evidence of its safety and as such it was given a score of 3 on our team's scale."

Answered by AI

Are researchers still accepting participants into this investigation?

"The data found on clinicaltrials.gov suggests that this medical study is not currently enlisting participants. This trial was posted to the website in March of 2024 and has experienced its most recent update in October 2023; however, there are 1,356 other studies actively recruiting now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Stephen Bruehl, PhD 2024. "Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06083480.

All > Osteoarthritis Knee > Knee Replacement