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NCT06096259RECRUITINGIRB Ready

Preventing Injured Knees From osteoArthritis: Severity Outcomes

(PIKASO)

Sponsored by Brigham and Women's Hospital

Quick Self-Assessment

See if you qualify and express your interest

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1 of 512 participants interested
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Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion 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 2. Plan to undergo ACL reconstruction within 12 months of injury

Exclusion Criteria

Inflammatory arthritis 2. Pregnancy and/or lactation, or plans to become pregnant in the next 12 months 3. Known contraindication to metformin 4. Current use of metformin or topiramate 5. Diabetes mellitus or diabetic ketoacidosis 6. Acute or chronic renal insufficiency 7. History of prior ACL tear on the index knee, with or without reconstruction 8. History of ACL tear on the contralateral knee within the past 12 months 9. Applying for or receiving Workers' Compensation for their knee injury 10. Joint space narrowing AND definite osteophyte(s) on weightbearing radiograph on index knee 11. Tibial plateau fracture on index knee 12. Concomitant avulsion fracture of index knee that will be treated surgically 13. Concomitant posterior cruciate ligament

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

512 participants

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Age Range

18 Years - 45 Years

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Gender

ALL

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Sponsor

Brigham and Women's Hospital

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Atlanta

Georgia

Location available
View Atlanta location page
RECRUITING

Iowa City

Iowa

Location available
View Iowa City location page
RECRUITING

Lexington

Kentucky

Location available
View Lexington location page
RECRUITING

Boston

Massachusetts

Location available
View Boston location page
RECRUITING

Omaha

Nebraska

Location available
View Omaha location page
RECRUITING

New York

New York

Location available
View New York location page
RECRUITING

Chapel Hill

North Carolina

Location available
View Chapel Hill location page
RECRUITING

Cleveland

Ohio

Location available
View Cleveland location page
RECRUITING

Columbus

Ohio

Location available
View Columbus location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for ACL Tear Treatment in Atlanta?

Join others in Georgia exploring innovative treatment options through clinical research

ACL Tear Treatment Options in Atlanta, Georgia

If you're searching for ACL Tear treatment in Atlanta, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Atlanta, Iowa City, Lexington and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with ACL Tear. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Georgia
Now Enrolling
Up to 512 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for ACL Tear?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for ACL Tear

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This ACL Tear Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06096259. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.