RECRUITING

Preventing Injured Knees From osteoArthritis: Severity Outcomes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Preventing Injured Knees From osteoArthritis: Severity Outcomes (PIKASO)

Quick Facts

Study Start:2024-05-06
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06096259

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. ACL tear documented on MRI within 6 months prior to screening
  3. 3. Plan to undergo ACL reconstruction
  1. 1. Inflammatory arthritis
  2. 2. Pregnancy and/or lactation, or plans to become pregnant in the next 12 months
  3. 3. Known contraindication to metformin
  4. 4. Current use of metformin or topiramate
  5. 5. Type I diabetes mellitus or diabetic ketoacidosis
  6. 6. Heavy alcohol consumption and/or known hepatic disease
  7. 7. Acute or chronic renal insufficiency
  8. 8. History of ACLR on either knee
  9. 9. Applying for or receiving Workers' Compensation for their knee injury
  10. 10. Joint space narrowing AND definite osteophyte(s) on weightbearing radiograph on index knee
  11. 11. Tibial plateau fracture on index knee
  12. 12. Concomitant avulsion fracture of index knee that will be treated surgically
  13. 13. Concomitant posterior cruciate ligament, medial collateral ligament, or lateral collateral ligament injury on index knee requiring surgical repair/reconstruction
  14. 14. Contraindication to MRI
  15. 15. Unable to speak and understand English
  16. 16. Diagnosis of cognitive impairment or otherwise unable to provide informed consent
  17. 17. Insufficient time for recruitment and drug titration: Surgery scheduled for \<14 days from the time of screening
  18. 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. 19. Plan for allograft at time of consent

Contacts and Locations

Study Contact

Faith Selzer, PhD
CONTACT
617-525-8617
fselzer@bwh.harvard.edu
Lily M Waddell, BA
CONTACT
6175259727
lmwaddell@bwh.harvard.edu

Principal Investigator

Morgan H Jones, MD, MPH
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Cale A Jacobs, PhD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Emory University
Atlanta, Georgia, 30322
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Kentucky
Lexington, Kentucky, 40504
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Hospital for Special Surgery
New York, New York, 10021
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 25599
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-06
Study Completion Date2029-12

Study Record Updates

Study Start Date2024-05-06
Study Completion Date2029-12

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee
  • Post-traumatic Osteoarthritis
  • ACL Tear