Status:
COMPLETED
Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military
Lead Sponsor:
Kessler Foundation
Collaborating Sponsors:
Walter Reed National Military Medical Center
Uniformed Services University of the Health Sciences
Conditions:
Tibial Meniscus Injuries
Knee Injuries
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief 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 f...
Detailed Description
This is randomized controlled trial to determine the efficacy of autologous, micro-fragmented adipose tissue (MFAT) injection under ultrasound guidance for meniscal injuries in active duty military pe...
Eligibility Criteria
Inclusion
- 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
- 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 Lyme disease of the joint.
- Malignancy within the last 5 years.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04274543
Start Date
July 1 2019
End Date
December 1 2024
Last Update
December 18 2024
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052