Lipogems Prospective Study

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Protocol Outline: The patient will undergo a diagnostic knee arthroscopy. This procedure would have been performed regardless of enrollment in the study. During the diagnostic knee arthroscopy, the surgeon will determine whether the patient is eligible to participate in the study. If the patient has a torn meniscus, inflamed joint lining or loose fragments in the knee, this will be removed and treated and he/she will still be eligible for the study. If, however, the physician determines that the patient needs more invasive treatments (such as cartilage transplantation, meniscal repair, removal of a substantial amount of your meniscus), then he/she will be excluded from the study and will not have fat tissue suctioned from his/her abdomen. The standard of care treatment will then proceed based on the physician's judgement. After the surgeon completes the arthroscopic procedure, the recommended amount of fat-derived stem cells (about 2 teaspoons) will be injected into the knee. There will be approximately 1 teaspoon of excess fat derived stem cells, which will be transported to our research facility so that the contents can be stored for later examination. After surgery, 5 visits are required by the patient over the following 12 months: at 2 weeks after surgery to monitor his/her incision, at 6 weeks, 12 weeks, 6 months and then finally 12 months.

Official Title
-----------------
Adipose Derived Stromal Cell Transplantation as an Adjunct to Arthroscopy in Treatment of Effusion Synovitis of the Early Degenerative Knee

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Lipogems Device PLUS debridement
* Procedure: Debridement only


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)<br>Experimental Group: will undergo diagnostic knee arthroscopy with injection of adipose derived stem cells. Will also carry out all procedures associated with study (Physical Exam, Magnetic Resonance Imaging (MRIs), X-rays, Questionnaires). | Device: Lipogems Device PLUS debridement<br>* 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.<br>|
| Other: Observation Cohort: Knee Arthroscopy<br>Observational Group: will undergo diagnostic knee arthroscopy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires). | Procedure: Debridement only<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale | Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms | Questions related to other knee symptoms other than pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op | 
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL) | Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op | 
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec) | Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op | 
| Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL) | Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op | 
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Form | Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms) | Baseline, 2-Week post-op, 6-Week post-op | 
| Change in Numerical Pain Rating Scale (NPRS) | Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable) | Baseline, 2-Week post-op, 6-Week post-op | 
| Change in Marx Activity Rating Scale | Measures frequency of activity in healthiest and most active state during past year Includes four knee functions, each rated 0-4 total scale range 0-16 (higher score indicates more frequent participation/activity) | Baseline, 2-Week post-op, 6-Week post-op | 
| Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10) | 10-item questionnaire with nine 5-point (as well as a single 11-point) rating scales. The results are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the T-Score. The average T-Score for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. 11-point scale question recalculated to a 5 point scale. only 8 of 10 questions used for scoring calculations (Each sub-score is generated by 4/8 questions) - 4Qs, 5 points each Scale from 0-20 to calculate Global Mental Health Raw Score (higher score means better outcome) Scale from 0-20 to calculate Global Physical Health Raw Score (higher score means better outcome) The raw scores are then standardized to general population using the T-score: Global physical health t-score range: 16.2-67.7 Global mental health t-score range: 21.2-67.6 | Baseline, 2-Week post-op, 6-Week post-op |