Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial

July 14, 2024 updated by: Michael Baria, Ohio State University

The study aims to conduct a randomized trial comparing the clinical outcomes of PRP (standard intervention) versus Microfragmented adipose tissue (investigational) for the treatment of knee osteoarthritis.

Hypothesis: Both interventions will result in significant improvement in patient-reported outcomes. We hypothesize that Microfragmented adipose tissue will provide superior outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background

Knee osteoarthritis is a leading cause of disability worldwide. Standard of care treatments for knee OA include activity modification, weight loss, therapeutic exercise and injections like corticosteroids and viscosupplement. These commonly used non-operative treatments focus on symptom palliation, but are not disease modifying.

Orthobiologics have emerged as a promising treatment for knee OA. The most widely studied orthobiologic is platelet-rich plasma (PRP). PRP is a dense concentration of platelets derived from autologous whole blood and platelets are concentrated 2-5x compared to baseline. The platelets have demonstrated anti-inflammatory and chondroprotective properties.6 PRP has been shown superior to placebo and viscosupplement for knee OA in several clinical trials.

While PRP is the most widely studied and used orthobiologic, it contains only platelets. Therefore, a simple, office-based intervention able to collect additional reparative cells to treat knee OA would be ideal. Adipose (fat) is a known source of reparative cells like pericytes and it can be easily and safely aspirated in the clinic. The adipose tissue aspiration and processing is accomplished through a simple process. After local anesthesia to the site of adipose aspiration (lower abdomen or buttock), 30ml of adipose is aspirated through a cannula. That adipose is then processed in accordance with FDA guidelines including minimal manipulation to remove oils.. Using minimally manipulated Microfragmented adipose tissue has been shown safe for use as injection therapy for knee OA for 3 years.

Methods:

Patients / Outcome Measures / Sample size: Patients with unilateral symptomatic knee OA will be recruited from the sports medicine and orthopedics clinics, as well as advertising flyers within the clinic. All patients' first visit will include a medical evaluation and assess best treatment plan for that patient, regardless of candidacy for this study. This evaluation includes x-rays of their knees as a standard part of the evaluation. If they meet criteria and choose to enroll, they will be randomly assigned to either the PRP or Microfragmented adipose tissuetreatment group. Patients will complete follow up visits and surveys at defined time points through 12 months.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43221
        • The Ohio State University Sports Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 25-75 years
  • BMI < 40
  • Diagnosis of knee OA (primary and post-traumatic)
  • Radiographic evidence of OA of the target knee (Kellgren-Lawrence grades 1-4)
  • Continued OA pain in the target knee despite at least 6 weeks of 1 of the following nonoperative treatments: activity modification, weight loss attempt, physical therapy, or NSAID / acetaminophen.
  • Knee Osteoarthritis Outcomes Score (KOOS)-Pain subscale 20-65
  • Working knowledge of English language (to be able to complete all outcome scores)
  • Ability to attend all follow-up appointments

Exclusion Criteria:

  • Isolated patellofemoral OA
  • 3+ effusion of the target knee (stroke test grading system)
  • Significant (10 degree) valgus or varus deformities
  • Prior injection therapy:
  • Steroid injection in target knee in the last 3 months
  • Viscosupplementation in target knee in the last 6 months
  • PRP in the target knee in the last 1 year
  • No other cellular treatments in index knee (bone marrow, amniotic suspensions etc) all time
  • Participation in any experimental device or drug study within 1 year before screening visit
  • Oral or IM steroids for last 3 months
  • Medical condition that may impact outcomes of procedure including:
  • anemia
  • thrombocytopenia
  • bleeding disorders
  • inflammatory disorders like rheumatoid arthritis, lupus
  • diabetes
  • any history of cancer (other than non-melanoma skin malignancies)
  • taking anticoagulants (aspirin, Plavix, eliquis, Xarelto, warfarin, lovenox)
  • Taking immunosuppressants, having a severe systemic infection
  • Previous cartilage repair procedure on the injured cartilage surface (ie, OATS, ACI, MFX)
  • Previous surgery at the target knee within the past 1 year
  • Any degree of cognitive impairment.
  • OA of either hip
  • Pregnancy, lactating, or intent to become pregnant during treatment period
  • Gout
  • History of infection or current infection at the affected joint
  • Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Platelet Rich Plasma
157cc of whole blood will be harvested via standard venipuncture from the antecubital fossa and mixed with 24cc ACD-A (manufacturer recommends 8cc ACD-A per 52cc of whole blood). 156ml of whole blood will be processed in the FDA Cleared Angel cPRP system at 2% hematocrit. 1ml of whole blood and the resultant PRP will be analyzed in the Sysmex XN-350 for complete analysis (platelet, leukocyte, red blood cell counts). The remaining PRP will be injected under sterile technique using ultrasound-guidance through a superolateral approach. For patient comfort, 2cc of 1% lidocaine can be administered using a 26-gauge needle (into soft tissues only). PRP will then be injected using a 25-guage needle. A maximum of 6ml of PRP will be injected. Injection site will be cleaned and bandaged and patient will be dismissed with post-injection precautions and 1 month follow-up scheduled.
Device: Platelet Rich Plasma

Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.

Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.

Other Names:
  • Microfragmented adipose tissue
Active Comparator: Microfragmented adipose tissue
Adipose is aspirated from the subcutaneous tissue of the buttock or abdomen. Aspiration site is injected with 10ml 1% lidocaine with epinephrine. A small poke incision is made with an 11-blade scalpel. Then 120ml of Klein solution is injected into the adipose tissue. Solution sits for 15 minutes to allow for adequate anesthesia. Aspiration cannula is inserted and moved in a back and forth motion for 2 minutes to allow for adipose aspiration. 30ml fat will be aspirated. Aspiration site is cleaned and bandaged. The aspirated fat is processed using the Lipogems system. 30ml of adipose is transferred to the device, saline is run through the device to remove oils and then approximately 5-7ml of adipose tissue is removed and ready for injection. The Microfragmented adipose tissue are then injected in identical fashion to the PRP above.
Device: Platelet Rich Plasma

Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.

Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.

Other Names:
  • Microfragmented adipose tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS Pain [Knee Injury and Osteoarthritis Outcome Score]
Time Frame: 6 months
The Knee injury and Osteoarthritis Outcome Pain Score [KOOS questionnaire] is a self-reported outcome measure assessing the patient's opinion about the pain in their knee. Standardized answer options are given [5 Likert boxes] and each question is assigned a score from 0 to 4. A normalized score [100 indicating no pain and 0 indicating extreme pain] is calculated.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS [Visual Analog Pain Scale] Pain Score
Time Frame: 6 months
The visual analog pain scale [VAS] is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 [no pain] and 10 [worst pain].
6 months
Tegner Activity Scale
Time Frame: 6 months
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Michael Baria, MD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2020

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

July 5, 2022

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

July 14, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019H0448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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