Fat Pad Syndrome
Conditions
Keywords
Fat Pad Impingement, Adipose Allograft Matrix
Brief summary
This study is to assess the effect of Renuva® on fat pad regeneration in patients with Fat pad Impingement
Detailed description
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.
Interventions
BIOLOGICALRenuva
Renuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee MRI measurements of fat pad thickness (mm) | 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. |
| Knee MRI measurements of fat pad surface area (mm2) | 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 volume (mm3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire | 6 Months | 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. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome | Baseline, 1 month, 3 month and 6 month | 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. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome | Baseline, 1 month, 3 month and 6 month | 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. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome | Baseline, 1 month, 3 month and 6 month | 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. |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome | Baseline, 1 month, 3 month and 6 month | 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. |
Countries
United States
Outcome results
None listed