Lipogems Prospective Study
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Lipogems Device PLUS debridement; Debridement only
Intervention description: Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.; Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to study the clinical outcomes and effects of the injection of
      fat-derived stem cells (the scientific name being "adipose derived autologous stem cell
      transplantation (ADAT)") as an addition to knee arthroscopy in the treatment of knee swelling
      and pain associated with mild to moderate knee osteoarthritis. Management of this condition
      remains a pervasive problem within orthopaedics. Lipogems is a Food and Drug Administration
      (FDA) approved technique. Lipogems is the name of the technology used to obtain stem cells
      from fat that will be aspirated/removed by suction from the abdomen. Fat will be processed to
      obtain stem cells which will then be injected into the knee after the physician completes
      knee arthroscopy. The study that we are asking patients to enroll in is important because it
      will attempt to answer the question about whether fat-derived stem cells added to knee
      arthroscopy is better, worse or no different than knee arthroscopy alone. Currently, without
      this study, we do not have an answer to this question.
    

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