Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment

Study Overview
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Brief Summary
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This study is to assess the effect of Renuva® on fat pad regeneration in patients with Fat pad Impingement

Detailed Description
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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.

Official Title
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Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment

Conditions
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Fat Pad Syndrome

Intervention / Treatment
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* Biological: Renuva


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renuva Injection<br>Each subject will receive a single injection of up to 3ccs of Renuva into their diseased fat pad. | Biological: Renuva<br>* Renuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee MRI measurements of fat pad thickness (mm) | 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. | 6 Months | 
| Knee MRI measurements of fat pad surface area (mm2) | 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. | 6 Months | 
| Knee MRI measurements of fat pad volume (mm3) | 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. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire | KOOS Pain evaluates short-term and long-term pain in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee pain. | 6 Months | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome | KOOS symptoms evaluates short-term and long-term symptoms in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee symptoms. | Baseline, 1 month, 3 month and 6 month | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome | KOOS ADL evaluates short-term and long-term function in daily living in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to daily living activity. | 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 | KOOS Sport/Rec evaluates short-term and long-term function in sports and recreation in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to sports or recreation activity. | Baseline, 1 month, 3 month and 6 month | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome | KOOS QOL evaluates short-term and long-term knee quality of life in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee related issues in regards to quality of life. | Baseline, 1 month, 3 month and 6 month | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome | KOOS Pain evaluates short-term and long-term pain in subjects with knee injury and osteoarthritis. Scores range from 0-100 where 100 represents no knee pain. | Baseline, 1 month, 3 month and 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fat Pad Impingement, Adipose Allograft Matrix