Clinical trial NCT05880888: Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment
Official title: Investigating the Clinical Impact of a Novel Adipose Allograft Matrix on Knee Fat Pad Impingement Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fat Pad Syndrome
Keywords: Fat Pad Impingement
Adipose Allograft Matrix
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee MRI measurements of fat pad thickness (mm)
timeFrame: 6 Months
measure: Knee MRI measurements of fat pad surface area (mm2)
timeFrame: 6 Months
measure: Knee MRI measurements of fat pad volume (mm3)
timeFrame: 6 Months
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire
timeFrame: 6 Months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome
timeFrame: Baseline, 1 month, 3 month and 6 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome
timeFrame: Baseline, 1 month, 3 month and 6 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome
timeFrame: Baseline, 1 month, 3 month and 6 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome
timeFrame: Baseline, 1 month, 3 month and 6 month
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome
timeFrame: Baseline, 1 month, 3 month and 6 month
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Jameson Crane Sports Medicine Institute
state: Ohio
city: Lewis Center
country: United States
facility: Ohio State Outpatient Lewis Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Michael Baria
role: PRINCIPAL_INVESTIGATOR
References: