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

NCT ID: NCT04274543

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2024-12-01

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.

Conditions

Tibial Meniscus Injuries; Knee Injuries; Knee Injuries and Disorders

Keywords

Regenerative Medicine; Knee Pain; Meniscus Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Micro-Fragmented Adipose Tissue

Participants will receive a single injection of normal saline (0.9%) solution into the lesion (e.g. tear) and knee joint under ultrasound guidance using an 18 gauge x 3.5 inch needle.

Group Type: EXPERIMENTAL

Lipogems

Intervention Type: DEVICE

The Lipogems system (Lipogems International SpA, Milan, Italy) is designed to isolate autologous, micro-fragmented adipose tissue without enzymes or other additives. It uses mild mechanical forces to break down adipose tissue that is extracted from the patient into a form that can be injected into the meniscal lesion and other degenerated tissues in a sterile and safe manner. The resulting product is rich in pericytes and mesenchymal stromal cells, retained within an intact stromal vascular niche, that is ready for use in clinical applications.

Saline

Participants will receive a single injection of micro-fragmented adipose tissue into the lesion (e.g. tear) and knee joint under ultrasound guidance using an 18 gauge x 3.5 inch needle.

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: DRUG

Normal Saline solution is a mixture of sodium chloride in water (9 g NaCl per liter water, 0.9% saline). Trephination allows for vascular growth and healing, especially in the inner avascular regions of the meniscus, by puncturing the meniscus. Small "tunnels" are created, which allow for healing factors to reach the avascular inner region of the meniscus from the vascular peripheral regions.

Interventions

Lipogems

The Lipogems system (Lipogems International SpA, Milan, Italy) is designed to isolate autologous, micro-fragmented adipose tissue without enzymes or other additives. It uses mild mechanical forces to break down adipose tissue that is extracted from the patient into a form that can be injected into the meniscal lesion and other degenerated tissues in a sterile and safe manner. The resulting product is rich in pericytes and mesenchymal stromal cells, retained within an intact stromal vascular niche, that is ready for use in clinical applications.

Intervention Type: DEVICE

Normal Saline

Normal Saline solution is a mixture of sodium chloride in water (9 g NaCl per liter water, 0.9% saline). Trephination allows for vascular growth and healing, especially in the inner avascular regions of the meniscus, by puncturing the meniscus. Small "tunnels" are created, which allow for healing factors to reach the avascular inner region of the meniscus from the vascular peripheral regions.

Intervention Type: DRUG

Other Intervention Names

Micro-fragmented Adipose Tissue; Percutaneous Trephination with Saline

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R-1065-19

Identifier Type: -

Identifier Source: org_study_id