• Home
  • Study Details
Open

Preventing Injured Knees from osteoArthritis

PIKASO compares the effects on pain relief and arthritis prevention of metformin or placebo, taken for a year following anterior cruciate ligament reconstruction (ACLR). *This study is a collaboration with the UNC Sports Medicine Institute*

Age & Gender

  • 18 years ~ 45 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Extended hours (M-F, early morning or evening)
  • Weekend hours, if needed
  • Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

The study will consist of two treatment arms: 1) metformin + physical therapy, or 2) placebo + physical therapy. The intervention will consist of a single daily dose of metformin or placebo administered orally for 1 year, in addition to standard-of-care physical rehabilitation. You will complete an MRI, X-Ray, patient reported surveys and an optional blood and urine collection pre-operatively. An optional knee aspiration and tissue biopsy will be conducted in the surgical limb at the time of ACLR. You will complete a questionnaire at 3-, 6-, 9- and 18-months post ACLR. You will also complete follow up assessments at 12- and 24-months including patient reported surveys, X-rays, MRIs and an optional urine/blood collection and physical tests.

Incentives

Compensation up to $1,660 - $2,260 if you complete all components of the study.

In-person visits:
3
Phone or online visits:
4
Total length of participation:
2 years

Looking for Specific Volunteers

Able to participate:

  • Anterior cruciate ligament tear within the past 6 months
  • Planning or scheduled for ACL reconstruction
  • between the ages of 18 and 45 years old

Not eligible if:

  • no history of anterior cruciate ligament reconstruction

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Biomedical Research Imaging Center
Marsico Hall (UNC-Chapel Hill)
125 Mason Farm Rd, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Orthopaedics (OrthoNow)
UNC Health at Carolina Pointe II
6011 Farrington Rd, Chapel Hill, NC 27517, USA

Additional Study Information

Principal Investigator

Joseph Hart
Orthopaedics

Study Type

Clinical or Medical
Interventional

Study Topics

Bones, Joints, Muscles
Pain
Wellness and Lifestyle
Surgery and post-operative healing

IRB Number

23-2674

ClinicalTrials.gov

NCT06096259

Research for Me logo

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

  • This email address is being protected from spambots. You need JavaScript enabled to view it.
logo for the North Carolina Translational and Clinical Sciences Institute
logo for UNC Health
logo for UNC School of Medicine
logo for UNC Research