CompletedPhase 2

Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military

United States3 participantsStarted 2019-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-45 years old. * At least one of the following symptoms consistent with torn meniscus: joint line pain, clicking, popping, pain with pivot or torque. * Physical examination findings consistent with a meniscal tear: joint line tenderness; localized pain with flexion; and other provocative tests such as McMurray's and Thessaly test. * MRI or arthroscopic evidence of meniscal tear without significant additional joint pathology. * Failed conservative treatment for a minimum of 4 weeks, which has included rest, ice, anti-inflammatory or other medications for pain; physical therapy; with or without/ injections, including corticosteroid and/or hyaluronic acid injections. Additional criteria: Patients who have been told by an orthopedic surgeon that they would be a candidate for arthroscopic partial meniscectomy. Exclusion Criteria: * Chronically locked knee. * Greater than Kellgren-Lawrence Grade II. * Prior surgery performed on the effected knee. * Assessment showing anything other than degenerative tears of the medial meniscus requiring surgical intervention. * Recent (within 6 weeks) treatment with PRP, cortisone (oral or injection), or hyaluronic injection. * Any disease or condition the investigator feels would hinder treatment. * Any contra-indication to lipoaspirate, including a bleeding disorder, infection, pregnancy, or allergy to anesthetic agents. * Chronic inflammatory diseases such as rheumatoid arthritis. * Possible joint infection including…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Numerical Rating Scale

Timeframe: 3 months

Trial details

NCT IDNCT04274543

SponsorKessler Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

View on ClinicalTrials.gov More Tibial Meniscus Injuries trials