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Completed

NCT Number: NCT05880888

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

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

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jameson Crane Sports Medicine Institute, Columbus, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renuva

Biological

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

Primary outcomes

  1. Knee MRI measurements of fat pad thickness (mm)

    Time frame: 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.

  2. Knee MRI measurements of fat pad surface area (mm2)

    Time frame: 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.

  3. Knee MRI measurements of fat pad volume (mm3)

    Time frame: 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 outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome questionnaire

    Time frame: 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.

  2. Knee injury and Osteoarthritis Outcome Score (KOOS) Symptoms patient reported outcome

    Time frame: 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.

  3. Knee injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) patient reported outcome

    Time frame: 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.

  4. Knee injury and Osteoarthritis Outcome Score (KOOS) Function in Sport and Recreation (Sport/Rec) patient reported outcome

    Time frame: 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.

  5. Knee injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life (QOL) patient reported outcome

    Time frame: 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.

  6. Knee injury and Osteoarthritis Outcome Score (KOOS) Pain patient reported outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 30, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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