Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lipogems Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922490
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date April 26, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
Change in Knee Injury and Osteoarthritis Outcome (KOOS) pain subscale [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03922490 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to other knee symptoms other than pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
  • Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL) [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
  • Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec) [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
  • Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL) [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
  • Change in International Knee Documentation Committee (IKDC) Subjective Knee Form [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms)
  • Change in Numerical Pain Rating Scale (NPRS) [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable)
  • Change in Marx Activity Rating Scale [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    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)
  • Change in Patient-Reported Outcomes Measurement Information System Global-10 short form (PROMIS-10) [ Time Frame: Baseline, 2-Week post-op, 6-Week post-op, 12-Week post-op, 24-Week post-op, 1 year post-op ]
    Measures symptoms, functioning and quality of life Includes 10 questions measuring general domains of health and functioning (9 question have scale range 1-5; higher score indicating higher level of health or functioning) (1 question has scale range 0-10; 0: No pain - 10: worst imaginable pain)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipogems Prospective Study
Official Title  ICMJE Adipose Derived Stromal Cell Transplantation as an Adjunct to Arthroscopy in Treatment of Effusion Synovitis of the Early Degenerative Knee
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Device: Lipogems Device PLUS debridement
    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.
  • Procedure: Debridement only
    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.
Study Arms  ICMJE
  • Experimental: Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
    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).
    Intervention: Device: Lipogems Device PLUS debridement
  • Observation Cohort: Knee Arthroscopy
    Observational Group: will undergo diagnostic knee arthscropy (No injection of adipose derived stem cells). Will also carry out all procedures associated with study (Physical Exam, MRIs, X-rays, Questionnaires).
    Intervention: Procedure: Debridement only
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tyler Warner 2126061693 warnert@hss.edu
Contact: Riley Williams, MD 2126061855
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922490
Other Study ID Numbers  ICMJE 2018-1534
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Riley Williams, MD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP