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NCT04274543 · ClinicalTrials.gov registry record · Phase 2
Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military
A Phase 2 study, sponsored by Kessler Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04274543: Completed Phase 2 study, sponsored by Kessler Foundation.
NCT04274543 is a Phase 2 study that has completed, run by Kessler Foundation. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04274543, a Phase 2 study, has completed, sponsored by Kessler Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Knee injuries are common among active-duty military personnel. One of the most common knee injuries is a meniscus tear, which can have several consequences. Immediately, the soldier may be separated from the military for over one year or assigned a permanent activity limiting duty profile. Over time, meniscal tears may also increase the risk of other knee injuries, such as osteoarthritis, which is one of the most common medical reasons for discharge from active duty service. The current standard of care includes conservative treatments, such as physical therapy and rest. Once conservative treatments fail, surgery is generally the next option. However, there is limited evidence that surgery is effective and some studies suggest it can accelerate the development of osteoarthritis. The goal of this study is to evaluate the efficacy of a regenerative treatment for meniscal tears termed micro-fragmented adipose tissue in reducing pain and restoring activity levels. We will recruit active-duty military personnel and civilians with meniscal tears and provide them with either the adipose tissue treatment or a control treatment consisting of saline. We will then follow these individuals for up to one year and evaluate differences in pain and function between the two groups. The ultimate goal is to show that micro-fragmented adipose tissue is a viable alternative for the treatment of meniscal tears in active-duty military personnel.
Primary Outcome
Knee pain intensity will be assessed using an 11-point numerical rating scale (NRS; 0-10, ranging from 0 = "no pain" to a maximum of 10= "pain as bad as you can imagine". Pain intensity is the most common pain domain assessed in research and clinical settings. Although different rating scales have proven to be valid for assessing pain intensity, the 11-point NRS has the most strengths and fewest weaknesses of available measures. An 11-point NRS measure of pain intensity allows for comparison acr
Interventions
- DRUG Normal Saline
- DEVICE Lipogems
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2024-12-01 |
| Phase | Phase 2 |
What the finished NCT04274543 record still lists
NCT04274543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT04274543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04274543 about?
NCT04274543 is a clinical study titled "Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military". Knee injuries are common among active-duty military personnel. One of the most common knee injuries is a meniscus tear, which can have several consequences. Immediately, the soldier may be separated from the military for over one year or assigned a permanent activity limiting duty profile. Over time...
What is the current status of trial NCT04274543?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2019-07-01. Estimated completion is 2024-12-01.
What interventions are being tested in trial NCT04274543?
The interventions under investigation include: Normal Saline (DRUG), Lipogems (DEVICE).
Who is sponsoring clinical trial NCT04274543?
This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04274543's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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