Preventing Injured Knees From osteoArthritis: Severity Outcomes
Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)
Brigham and Women's Hospital
512 participants
May 6, 2024
INTERVENTIONAL
Conditions
Summary
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. The placebo tablet looks exactly like metformin, but contains no metformin. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat type II diabetes. Notably, it also has anti-inflammatory effects, suggesting it could benefit people who have an ACL injury and are undergoing ACL reconstruction.
Eligibility
Inclusion Criteria2
- 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
Exclusion Criteria20
- 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
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Interventions
Metformin is an oral anti-hyperglycemic agent widely used as first-line treatment for type II diabetes to improve glycemic control. It is the fourth most commonly prescribed drug in the United States. Participants will receive commercially available extended-release metformin 500mg tablets manufactured by Granules India Limited, Hyderabad, India and then sourced, packaged, and labeled for the study by Sharp Labs. The study will follow standard dosing procedures for extended-release metformin. Participants will begin by taking 1x500 mg pill once a day, and then the dose will be increased in 500 mg/day increments every 5 days as tolerated, up to a maximum dose of 1500 mg daily.
The study will use matching placebo tablets that are almost indistinguishable from the 500 mg metformin ER tablets. Participants will begin by taking 1x500 mg pill once a day, and then the dose will be increased in 500 mg/day increments every 5 days as tolerated, up to a maximum dose of 1500 mg daily.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT06096259