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NCT06096259 · ClinicalTrials.gov registry record · Phase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
A Phase 2 study of Osteoarthritis, Knee and Post-traumatic Osteoarthritis, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 512
- Enrollment target
- 9
- Study locations
NCT06096259: Recruiting Phase 2 study of Osteoarthritis, Knee and Post-traumatic Osteoarthritis, sponsored by Brigham and Women's Hospital.
NCT06096259 is a Phase 2 study of Osteoarthritis, Knee and Post-traumatic Osteoarthritis that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 512 participants, roughly in line with the 493-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target. The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06096259, a Phase 2 study of Osteoarthritis, Knee and Post-traumatic Osteoarthritis, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 512 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
To determine whether metformin leads to reduced pain as measured by the KOOS pain subscale compared to placebo between 12 and 24 months postoperatively. Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS pain subscale contains 9 items and is scored on a 0-100 scale, 100 being best.
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 |
What NCT06096259 shows while recruiting
NCT06096259 is an interventional study that assigns participants to a tested intervention. The registered 512 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 493-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target.
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.
NCT06096259 lists 9 locations in 8 states (Ohio, Georgia, Iowa).
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.
What interventions are being tested in trial NCT06096259?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT06096259?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Osteoarthritis, Knee
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06096259's enrollment target sits among peer trials
512 19th of 112 higher than 94 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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