Clinical trial NCT04274543: Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military
Official title: Use of Autologous, Micro-Fragmented Adipose Tissue to Treat Meniscal Injuries in Active Duty Military Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tibial Meniscus Injuries
Knee Injuries
Knee Injuries and Disorders
Keywords: Regenerative Medicine
Knee Pain
Meniscus Tear
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Walter Reed National Military Medical Center
name: Uniformed Services University of the Health Sciences
First posted: 2020-02-18
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 personnel. The control for this study, to which MFAT will be compared, is trephination with saline injection into the meniscal tear. Eighty (80) healthy, phyisically-fit men and women with confirmed, acute meniscal tears will be recruited and placed into one of two treatment groups.

Percutaneous trephination with MFAT: Micro-fragmented adipose tissue will be obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any additives. The final product will consist of micronized fat tissue yielding fat clusters with preserved vascular stroma of about 500 microns with intact stromal vascular niches and harboring regenerative cellular elements. Approximately 1-2 mL of micro-fragmented adipose will be injected into the meniscus with an 18-gauge x 3.5 inch needle under continuous ultrasound guidance. An additional 4-5 mL will be injected into the knee joint. No other biological or pharmacological agents will be used in combination with the micro-fragmented adipose.

Percutaneous trephination with saline: In this group, the physician will identify the mensical lesion using ultrasound and will trephinate the torn meniscus with normal saline (0.9%) solution using an 18 guage x 3.5 inch needle. Approximately 1-2 mL will be injected into the meniscus and an additional 4-5 mL will be injected into the knee joint under ultrasound guidance.

Both Groups: Participants will be followed for adverse events and changes in shoulder pain intensity on an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine"); the Knee Injury and Osteoarthritis Outcome Score (KOOS); the PROMIS Physical Functioning short form; knee physical and ultrasound examinations; and a 5-point subject global impression of change (SGIC) scale. Subjects will be examined at 1 month, 2 months, 3 months, 6 months, and 12 months after the treatment.

Eligibility criteria: 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 Lyme disease of the joint.
* Malignancy within the last 5 years.

Primary outcomes:
measure: Change in Numerical Rating Scale
timeFrame: 3 months
Secondary outcomes:
measure: Patient Global Impression of Change
timeFrame: 3 months
measure: Patient Global Impression of Change
timeFrame: 6 months
measure: Patient Global Impression of Change
timeFrame: 12 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 3 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 6 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 12 months
measure: Change in Numerical Rating Scale
timeFrame: 6 months
measure: Change in Numerical Rating Scale
timeFrame: 12 months
measure: PROMIS-Physical Functioning Short Form
timeFrame: 3 months
measure: PROMIS-Physical Functioning Short Form
timeFrame: 6 months
measure: PROMIS-Physical Functioning Short Form
timeFrame: 12 months
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: