Preventing Injured Knees From osteoArthritis: Severity Outcomes

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06096259
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Metformin is an oral anti-hyperglycemic agent widely used as first-line treatment for type II diabetes to improve glycemic control. It is the fourth most commonly prescribed drug in the United States. Participants will receive commercially available extended-release metformin 500mg tablets manufactured by Granules India Limited, Hyderabad, India and then sourced, packaged, and labeled for the study by Sharp Labs. The study will follow standard dosing procedures for extended-release metformin. Participants will begin by taking 1x500 mg pill once a day, and then the dose will be increased in 500 mg/day increments every 5 days as tolerated, up to a maximum dose of 1500 mg daily.
  • Placebo — DRUG
    The study will use matching placebo tablets that are almost indistinguishable from the 500 mg metformin ER tablets. Participants will begin by taking 1x500 mg pill once a day, and then the dose will be increased in 500 mg/day increments every 5 days as tolerated, up to a maximum dose of 1500 mg daily.

Study Details

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.

Key Dates

Start date
May 6, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
512 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Metformin
    3x500mg metformin hydrochloride (HCl) extended-release (ER) tablets taken orally once a day for 1 year
  • Placebo Comparator: Placebo
    3x metformin placebo tablets matching metformin extended-release taken orally once a day for 1 year

Primary Outcome Measure

KOOS Pain Score [ Time Frame: Average of 12 and 24 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Gregory D Myer, PhD (PRINCIPAL_INVESTIGATOR)
University of Iowa Hospitals and ClinicsIowa CityIowa52242
Don D Anderson, PhD (PRINCIPAL_INVESTIGATOR)
Brian R Wolf, MD (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40504
Austin V Stone, MD, PhD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Rachel Lovejoy
[email protected]
6177326934
Morgan H Jones, MD, MPH (PRINCIPAL_INVESTIGATOR)
Cale A Jacobs, PhD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Elizabeth A Wellsandt, PT, PhD (PRINCIPAL_INVESTIGATOR)
Yvonne Golightly, PT, PhD (PRINCIPAL_INVESTIGATOR)
Hospital for Special SurgeryNew YorkNew York10021
Scott A Rodeo, MD (PRINCIPAL_INVESTIGATOR)
Miguel Otero, PhD (PRINCIPAL_INVESTIGATOR)
The University of North Carolina at Chapel HillChapel HillNorth Carolina25599
Joe M Hart, PhD (PRINCIPAL_INVESTIGATOR)
Brian G Pietrosimone, PhD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Kurt Spindler, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Laura C Schmitt, PT, PhD (PRINCIPAL_INVESTIGATOR)
Robert A Magnussen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory University· Atlanta, GAUniversity of Iowa Hospitals and Clinics· Iowa City, IAUniversity of Kentucky· Lexington, KYBrigham and Women's Hospital· Boston, MAUniversity of Nebraska Medical Center· Omaha, NEHospital for Special Surgery· New York, NY

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