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

About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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
Sites / Locations
- The Ohio State University Sports Medicine Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Platelet Rich Plasma
Microfragmented adipose tissue
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.
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.