Clinical trial NCT04351087: Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial
Official title: Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Microfragmented Adipose Tissue
Platelet-Rich Plasma
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 79
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-treatment parallel-design
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: KOOS Pain [Knee Injury and Osteoarthritis Outcome Score]
timeFrame: 6 months
Secondary outcomes:
measure: VAS [Visual Analog Pain Scale] Pain Score
timeFrame: 6 months
measure: Tegner Activity Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Sports Medicine Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Michael Baria, MD
role: PRINCIPAL_INVESTIGATOR
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