BridgeMD
New treatment option for Osteoarthritis, Knee
Official title Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06083480
What this study is testing
What is GlyNAC (combination of glycine and n-acetylcysteine)?
GlyNAC (combination of glycine and n-acetylcysteine) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for osteoarthritis, knee.
Also referred to as GlyNAC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.