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Anti-diabetic agent

Metformin for Osteoarthritis After ACL Surgery (PIKASO Trial)

Phase 2

Recruiting

Led By Morgan H Jones, MD, MPH

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

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

Must have

Plan to undergo ACL reconstruction

Be between 18 and 65 years old

Must not have

Inflammatory arthritis

Known contraindication to metformin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Summary

This trial will see if taking metformin can help reduce pain & delay PTOA after ACL surgery. Placebos will be used to compare results & see if the effects are due to the drug or other reasons.

Who is the study for?

This trial is for adults aged 25-45, or those 18-24 with significant preoperative knee pain, who have an ACL tear confirmed by MRI and plan to undergo reconstruction. It's not for individuals with inflammatory arthritis, kidney issues, heavy alcohol use, hepatic disease, pregnancy plans within a year, current metformin users or those with certain other knee injuries.

What is being tested?

The study tests if metformin can reduce pain and delay post-traumatic osteoarthritis after ACL surgery compared to a placebo (a pill without the drug). Metformin is known as a diabetes medication but may help due to its anti-inflammatory properties.

What are the potential side effects?

While the side effects specific to this trial are not listed here, common side effects of metformin include gastrointestinal symptoms like nausea and diarrhea. Placebos typically do not cause side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am planning to have ACL reconstruction surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have inflammatory arthritis.

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I cannot take metformin due to health reasons.

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I am currently taking metformin or topiramate.

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I have had ACL reconstruction surgery on one of my knees.

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My knee X-ray shows cartilage loss and bone spurs.

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I have a broken upper part of my shinbone in my knee.

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I am scheduled for a transplant from a donor.

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I need surgery for a knee ligament injury besides the ACL.

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I am able to understand and give consent for my treatment.

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My surgery is scheduled in less than 14 days from now.

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I have Type 1 diabetes or have experienced diabetic ketoacidosis.

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I drink heavily or have a liver disease.

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I have a knee fracture that requires surgery.

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I have kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months for reporting.