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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: Active Phase 4 study of Osteoarthritis, Knee and Meniscus Tear, sponsored by The Cleveland Clinic.
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 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (70% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Knee pain of participants; a higher score represents a desired outcome; zero representing extreme knee problems and 100 representing no knee problems
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 |
What the registry record for NCT04641351 still lists
NCT04641351 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (70% lower).
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 a single indexed study location in 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.
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 NCT04641351's enrollment target sits among peer trials
150 43rd of 112 higher than 66 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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