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

NCT04274543 | Completed Phase 2 DMC FDA Device

• 1 other identifier: R-1065-19
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Meniscus Injuries; Knee Injuries; Knee Injuries and Disorders

Keywords

Regenerative Medicine; Knee Pain; Meniscus Tear

Outcome Measures

Primary Outcomes (1)

• Change in Numerical Rating Scale

  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 across clinical trials of chronic pain treatment and has been recommended by the IMMPACT consensus group for use in pain clinical trials and by the 2006 NIDRR SCI Pain outcome measures consensus group. We will evaluate changes in scores between baseline and 3 months.

  3 months

Secondary Outcomes (11)

• Patient Global Impression of Change

  3 months

• Patient Global Impression of Change

  6 months

• Patient Global Impression of Change

  12 months

• Knee Injury and Osteoarthritis Outcome Score

  3 months

• Knee Injury and Osteoarthritis Outcome Score

  6 months

Study Arms (2)

Micro-Fragmented Adipose Tissue

EXPERIMENTAL

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.

Device: Lipogems

Saline

ACTIVE COMPARATOR

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.

Drug: Normal Saline

Interventions

Lipogems 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.

Also known as: Micro-fragmented Adipose Tissue

Micro-Fragmented Adipose Tissue

Normal Saline 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.

Also known as: Percutaneous Trephination with Saline

Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• Walter Reed National Military Medical Center: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Tibial Meniscus Injuries; Knee Injuries; Disease

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blinded to treatment group when analyzing data for publication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: February 18, 2020
• Study Start: July 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

US (1)