Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Knee MRI measurements of fat pad volume (mm3)
研究概览
简要总结
This study is to assess the effect of Renuva® on fat pad regeneration in patients with Fat pad Impingement
详细描述
The fat pad of the knee works to stabilize the patella and releases cytokines, growth factors, and stem cells. These cytokines, growth factors, and stem cells exhibit anti-inflammatory, anabolic effects that can be recruited to heal the articular tissues of the knee and ameliorate their catabolic effects during osteoarthritis (OA).
The majority of the current treatments for fat pad impingement (FPI) and its sequelae are primarily symptom-modifying, and structure-modifying therapies both at the joint and peri-articular structures levels cannot be overemphasized.
Renuva® (MTF Biologics) is a Food and Drug Administration approved, off-the-shelf, injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue. Once injected, native cell populations infiltrate the AAM, and over time, the AAM remodels into native tissue and stimulates both adipogenesis and angiogenesis within the tissue.
Our specific aim is to assess the effect of Renuva® on fat pad regeneration in patients with FPI. The investigators hypothesize that injection of Renuva® into a diseased fat pad of the knee increase the volume of the fat pad and reduce any hemorrhage, edema or fibrosis present, when pre-to post-treatment images are compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-85 years of age
- •Fat pad impingement
- •Knee MRI taken before study enrollment
- •Working knowledge of English language (to be able to complete all outcome scores)
- •Ability to attend all follow-up appointments.
- •Able to undergo MRI
排除标准
- •Medical condition that may impact outcomes of procedure including:
- •Systemic inflammatory disorders that impact the joints like rheumatoid arthritis, lupus, etc
- •Undergoing current cancer treatment (other than non-melanoma skin malignancies)
- •Gout, Pseudogout (including radiographic evidence of chondrocalcinosis)
- •History of infection or current infection at the affected joint
- •Smoking (Former smokers< 1 year from quit date)
- •Significant allergies manifested by a history of anaphylaxis or severe allergen sensitivity
研究组 & 干预措施
Renuva Injection
Each subject will receive a single injection of up to 3ccs of Renuva into their diseased fat pad.
干预措施: Renuva (Biological)
结局指标
主要结局
Knee MRI measurements of fat pad volume (mm3)
时间窗: 6 Months
Knee MRI will be taken at 6 months post injection to compare the fat pad volume to the MRI taken prior to the injection of Renuva.
Knee MRI measurements of fat pad surface area (mm2)
时间窗: 6 Months
Knee MRI will be taken at 6 months post injection to compare the fat pad surface area (mm2) to the MRI taken prior to the injection of Renuva.
Knee MRI measurements of fat pad thickness (mm)
时间窗: 6 Months
Knee MRI will be taken at 6 months post injection to compare the fat pad thickness (mm) to the MRI taken prior to the injection of Renuva.
次要结局
- Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome(Baseline, 1 month, 3 month and 6 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome(Baseline, 1 month, 3 month and 6 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire(6 Months)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome(Baseline, 1 month, 3 month and 6 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome(Baseline, 1 month, 3 month and 6 month)
- Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome(Baseline, 1 month, 3 month and 6 month)
研究者
Michael Baria
Associate Professor of Physical Medicine and Rehabilitation
Ohio State University