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Preventing Injured Knees From osteoArthritis: Severity Outcomes
NCT06096259 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG Placebo
- DRUG Metformin
Study Locations (9)
Ohio
- Cleveland Clinic — Cleveland
- The Ohio State University — Columbus
Georgia
- Emory University — Atlanta
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
Kentucky
- University of Kentucky — Lexington
Massachusetts
- Brigham and Women's Hospital — Boston
Nebraska
- University of Nebraska Medical Center — Omaha
New York
- Hospital for Special Surgery — New York
North Carolina
- The University of North Carolina at Chapel Hill — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2024-05-06 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06096259
The ClinicalTrials.gov registry entry for NCT06096259 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 512 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06096259 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Ohio, Georgia, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06096259 about?
NCT06096259 is a clinical study titled "Preventing Injured Knees From osteoArthritis: Severity Outcomes". 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,...
What is the current status of trial NCT06096259?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 512 participants. The study started on 2024-05-06. Estimated completion is 2029-12.
What conditions does trial NCT06096259 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Post-traumatic Osteoarthritis, ACL Tear. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06096259?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06096259?
This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06096259 being conducted?
This trial has 9 study locations across Georgia, Iowa, Kentucky, Massachusetts, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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