Use of Autologous, Micro-Fragmented Adipose Tissue to Treat Meniscal Injuries in Active Duty Military Personnel
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Numerical Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor will be blinded to treatment group when analyzing data for publication.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Lipogems (Device)
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.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change in Numerical Rating Scale
时间窗: 3 months
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.
次要结局
- Patient Global Impression of Change(12 months)
- Change in Numerical Rating Scale(12 months)
- PROMIS-Physical Functioning Short Form(12 months)
- Knee Injury and Osteoarthritis Outcome Score(12 months)