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

Ohio State University3 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fat Pad Syndrome

Interventions

RenuvaBIOLOGICAL

Renuva® (MTF Biologics) is an injectable decellularized allograft adipose matrix (AAM) used to increase volume in adipose tissue.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States

Ohio State Outpatient Lewis Center

Lewis Center, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 6 Months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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