Preventing Injured Knees From osteoArthritis: Severity Outcomes

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 19, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Preventing Injured Knees From Osteoarthritis: Severity Outcomes," is investigating whether the medication metformin can help reduce pain and delay the development of post-traumatic osteoarthritis (PTOA) in patients who have undergone surgery for an anterior cruciate ligament (ACL) tear. The study will compare those taking metformin to a group receiving a placebo, which is a look-alike pill that contains no active medication. Metformin is commonly used to treat type II diabetes, but it also has properties that may help reduce inflammation, potentially benefiting individuals recovering from an ACL injury.

To participate in this trial, individuals must be between 18 and 45 years old and have a documented ACL tear that occurred within the last six months. They should also plan to have ACL reconstruction surgery. There are several conditions that would exclude someone from joining, such as having certain types of arthritis, being pregnant, or having specific health issues. Participants can expect to take either metformin or the placebo and will be monitored for their pain levels and knee function over time. This study aims to provide valuable information on whether metformin could be a helpful treatment for preventing further knee issues after an ACL injury.

Gender

ALL

Eligibility criteria

• Inclusion 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. Plan to undergo ACL reconstruction within 12 months of injury
• Exclusion Criteria:
• • 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. 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, 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. Date of injury more than 6-months ago, relative to date of screening
• • 19. 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
• • 20. Plan for allograft at time of consent