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New treatment option for Osteoarthritis, Knee
Official title Preventing Injured Knees From osteoArthritis: Severity Outcomes
ClinicalTrials.gov ID: NCT06096259
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for osteoarthritis, knee.
Also referred to as Glumetza, Fortamet.
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 study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior cruciate ligament (ACL) reconstruction. This research study will compare metformin to placebo.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- Age 25-45 or Age 18-24 with preoperative KOOS Pain \<80 (0-100, 100 best) recorded at least 14 days after the day of ACL injury
- Plan to undergo ACL reconstruction within 12 months of injury
You likely can't join if
- Inflammatory arthritis
- Pregnancy and/or lactation, or plans to become pregnant in the next 12 months
- Known contraindication to metformin
- Current use of metformin or topiramate
- Diabetes mellitus or diabetic ketoacidosis
- Acute or chronic renal insufficiency
See the full eligibility criteria
- Age 25-45 or Age 18-24 with preoperative KOOS Pain \<80 (0-100, 100 best) recorded at least 14 days after the day of ACL injury
- Plan to undergo ACL reconstruction within 12 months of injury
- Inflammatory arthritis
- Pregnancy and/or lactation, or plans to become pregnant in the next 12 months
- Known contraindication to metformin
- Current use of metformin or topiramate
- Diabetes mellitus or diabetic ketoacidosis
- Acute or chronic renal insufficiency
- History of prior ACL tear on the index knee, with or without reconstruction
- History of ACL tear on the contralateral knee within the past 12 months
- Applying for or receiving Workers' Compensation for their knee injury
- Joint space narrowing AND definite osteophyte(s) on weightbearing radiograph on index knee
- Tibial plateau fracture on index knee
- Concomitant avulsion fracture of index knee that will be treated surgically
- Concomitant posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament injury on index knee requiring surgical repair/reconstruction
- Contraindication to MRI
- Unable to speak and understand English
- Diagnosis of cognitive impairment or otherwise unable to provide informed consent
- Insufficient time for recruitment and drug titration: Surgery scheduled for \<14 days from the time of screening
- Date of injury more than 6-months ago, relative to date of screening
- Presence of a condition or abnormality that in the opinion of the surgeon investigator would compromise the safety of the patient or the quality of the data
- Plan for allograft at time of consent
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Iowa City, Iowa, United States; Lexington, Kentucky, United States; Boston, Massachusetts, United States; Omaha, Nebraska, United States; New York, New York, United States and 3 more location(s). 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.