Clinical trial: Lipogems Prospective Study (NCT03922490)

Eligibility criteria:
Inclusion Criteria:

          -  Age between 18 and 70 years

          -  Knee pain and symptoms for >2 months - clicking, popping, giving way, pain with pivot
             or torque, pain that is episodic, and pain that is acute and localized to one joint

          -  Conservative treatment >4 weeks with one or more of:

          -  Non-steroidal Anti-inflammatory Drugs (NSAIDS) or acetaminophen or contraindication to
             use of NSAIDs and acetaminophen, Activity limitations, Physical Therapy (PT)

          -  Hospital for Special Surgery (HSS) MRI demonstrating grade 1-3 knee joint
             effusion/synovitis based on MRI Osteoarthritis Knee Score (MOAKS) criteria

          -  K-L grade 0-3 on radiographs and/or cartilage thinning on MRI w/ or w/o meniscal tear

          -  Ability to provide informed consent

        Exclusion Criteria: The patients listed below are excluded due to potential confound
        factors which may alter clinical outcomes in either treatment group (1,3,4,5 7,8, 11,
        12,13), if they may potentially cause a ceiling or floor effect to our clinical outcomes
        (2,6,) or if the treatment may constitute and undue risk to the patient or be outside of
        the standard of practice of treatment for that patient (1, 9, 10,14, 15, 16)

          -  1. Under 18 years of age or skeletally immature

          -  2. Grade 4 radiographic Osteoarthritis (OA) as defined by the K-L classification

          -  3. Grade 4 chondral lesion of patellofemoral joint on diagnostic arthroscopy

          -  4. Major coronal plane malalignment (>5° valgus or varus deviation)

          -  5. Knee ligamentous instability

          -  6. Pretreatment Numeric Rating Scale (NRS) pain score of <40 of 100

          -  7. Systemic disorders such as diabetes, inflammatory arthritis (Rheumatoid Arthritis
             (RA), gout, psoriatic arthritis, Calcium Pyrophosphate Deposition Diseases (CPPD)),
             hematological diseases (coagulopathies),severe cardiovascular diseases, systemic
             infections, or immunodeficiencies.

          -  8. History of septic arthritis

          -  9. Ventral hernia (if abdominal donor site)

          -  10. Lipomatous neoplasm in region of proposed donor site.

          -  11. Current use of anticoagulant medications in the 5 days before surgical
             intervention

          -  12. Recent intra-articular injection of corticosteroids (within 30 days) or

          -  13. prior treatment with Hyaluronic acid (HA) in past 6 months.

          -  14. Knee surgery within the previous 2 months

          -  15. Pregnancy or possible pregnancy

          -  16. Epilepsy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment