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NCT04641351 · ClinicalTrials.gov registry record · Phase 4
Corticosteroid Meniscectomy Randomized Trial
A Phase 4 study of Osteoarthritis, Knee and Meniscus Tear, sponsored by The Cleveland Clinic.
- Active
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT04641351 is a Phase 4 study of Osteoarthritis, Knee and Meniscus Tear that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 150 participants, below the 578-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04641351, a Phase 4 study of Osteoarthritis, Knee and Meniscus Tear, is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study Summary
Synovitis has an important role in the symptoms and progression of Osteoarthritis (OA). Inflamed synovium has been associated with both increased symptoms and increased progression in OA patients. Furthermore, synovitis observed during knee arthroscopy in our patients undergoing arthroscopic partial meniscectomy (APM) was associated with worse symptoms while adjusting for confounding factors.Therefore, a better understanding of synovitis as a predictor of outcome after APM and as a target for treatment is needed to improve outcomes in this patient population. Triamcinolone has been shown to decrease synovitis-associated outcomes in both animal and human studies after anterior cruciate ligament (ACL) injury. In a porcine model of ACL injury, treatment with triamcinolone resulted in decreased formation of synovitis-related collagen breakdown products as well as decreased cellularity of the synovium.And in a trial of triamcinolone injected after ACL injury, similar findings of decreased C-telopeptide of type II collagen (CTX-II), associated with collagen type II breakdown, was found in knees administered triamcinolone compared to placebo controls.
Conditions Studied
Interventions
- DRUG Zilretta Injectable Product or Placebo
Study Locations (2)
Massachusetts
- Bringham and Women's Hospital - Boston
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-05-27 |
| Est. Completion | 2026-08-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04641351
The ClinicalTrials.gov registry entry for NCT04641351 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 578-participant average among 91 other Osteoarthritis, Knee trials with a reported enrollment target (74% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 1 intervention - of which Zilretta Injectable Product or Placebo is the first listed.
NCT04641351 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT04641351 about?
NCT04641351 is a clinical study titled "Corticosteroid Meniscectomy Randomized Trial". Synovitis has an important role in the symptoms and progression of Osteoarthritis (OA). Inflamed synovium has been associated with both increased symptoms and increased progression in OA patients. Furthermore, synovitis observed during knee arthroscopy in our patients undergoing arthroscopic partial...
What is the current status of trial NCT04641351?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2021-05-27. Estimated completion is 2026-08-01.
What conditions does trial NCT04641351 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Meniscus Tear, Synovitis, Meniscus; Degeneration.
What interventions are being tested in trial NCT04641351?
The interventions under investigation include: Zilretta Injectable Product or Placebo (DRUG).
Who is sponsoring clinical trial NCT04641351?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04641351 being conducted?
This trial has 2 study locations across Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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