Preventing Injured Knees From osteoArthritis: Severity Outcomes

Description

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.

Conditions

Osteoarthritis, Knee, Post-traumatic Osteoarthritis, ACL Tear

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Study Overview

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Study Details

Study overview

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.

Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)

Preventing Injured Knees From osteoArthritis: Severity Outcomes

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40504

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

New York

Hospital for Special Surgery, New York, New York, United States, 10021

Chapel Hill

The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 25599

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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. ACL tear documented on MRI within 6 months prior to screening
  • 3. Plan to undergo ACL reconstruction
  • 1. 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. Type I diabetes mellitus or diabetic ketoacidosis
  • 6. Heavy alcohol consumption and/or known hepatic disease
  • 7. Acute or chronic renal insufficiency
  • 8. History of ACLR on either knee
  • 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, medial collateral ligament, or lateral collateral ligament injury on index knee requiring surgical repair/reconstruction
  • 14. Contraindication to MRI
  • 15. Unable to speak and understand English
  • 16. Diagnosis of cognitive impairment or otherwise unable to provide informed consent
  • 17. Insufficient time for recruitment and drug titration: Surgery scheduled for \<14 days from the time of screening
  • 18. 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
  • 19. Plan for allograft at time of consent

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Morgan H Jones, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Cale A Jacobs, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2029-12