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Lipogems Prospective Study

Primary Purpose

Knee Osteoarthritis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lipogems Device PLUS debridement
Debridement only
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)

Observation Cohort: Knee Arthroscopy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
Change in Numerical Pain Rating Scale (NPRS)
Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable)
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)
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

Full Information

First Posted
April 10, 2019
Last Updated
January 18, 2023
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03922490
Brief Title
Lipogems Prospective Study
Official Title
Adipose Derived Stromal Cell Transplantation as an Adjunct to Arthroscopy in Treatment of Effusion Synovitis of the Early Degenerative Knee
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment was suspended due to the COVID pandemic and it was decided not to resume the study.
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee Arthroscopy + Adipose Derived Stem Cells (ADSC)
Arm Type
Experimental
Arm Description
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).
Arm Title
Observation Cohort: Knee Arthroscopy
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Lipogems Device PLUS debridement
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.
Intervention Type
Procedure
Intervention Name(s)
Debridement only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Pain Subscale
Description
Questions related to knee pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Time Frame
Baseline, 2-Week post-op, 6-Week post-op
Secondary Outcome Measure Information:
Title
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Symptoms
Description
Questions related to other knee symptoms other than pain Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Time Frame
Baseline, 2-Week post-op, 6-Week post-op
Title
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Daily Living (ADL)
Description
Questions related to function in daily living Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Time Frame
Baseline, 2-Week post-op, 6-Week post-op
Title
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Function in Sport and Recreation (Sport/Rec)
Description
Questions related to function in sport and recreation Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Time Frame
Baseline, 2-Week post-op, 6-Week post-op
Title
Change in Knee Injury and Osteoarthritis Outcome (KOOS) Quality of Life (QOL)
Description
Questions related to knee-related quality of life Scale range: 0-100 points (100 indicating no symptoms and 0 indicating extreme symptoms)
Time Frame
Baseline, 2-Week post-op, 6-Week post-op
Title
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form
Description
Questions related to knee function over periods of time (100 indicating no symptoms and 0 indicating extreme symptoms)
Time Frame
Baseline, 2-Week post-op, 6-Week post-op
Title
Change in Numerical Pain Rating Scale (NPRS)
Description
Numerical pain rating scale for pain in knee (0-10) (0: no pain - 10: worst pain imaginable)
Time Frame
Baseline, 2-Week post-op, 6-Week post-op
Title
Change in Marx Activity Rating Scale
Description
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)
Time Frame
Baseline, 2-Week post-op, 6-Week post-op
Title
Change in Patient-Reported Outcomes Measurement Information System Global-10 Short Form (PROMIS-10)
Description
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
Time Frame
Baseline, 2-Week post-op, 6-Week post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riley Williams, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Lipogems Prospective Study

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