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出境医 / 临床实验 / Lipogems Prospective Study

Lipogems Prospective Study

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Lipogems Device PLUS debridement Procedure: Debridement only Phase 4

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose Derived Stromal Cell Transplantation as an Adjunct to Arthroscopy in Treatment of Effusion Synovitis of the Early Degenerative Knee
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : August 12, 2021
Estimated Study Completion Date : August 12, 2021
Arms and Interventions
Arm Intervention/treatment
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).
 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.
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).
 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.
Outcome Measures
Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Layout table for investigator information
Principal Investigator: Riley Williams, MD 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 February 15, 2021
Actual Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date August 12, 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
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 *
  • Atukorala I, Kwoh CK, Guermazi A, Roemer F, Boudreau R, Hannon MJ, Hunter DJ. Response to: 'Synovitis in knee osteoarthritis: a precursor or concomitant feature?' by Zeng et al. Ann Rheum Dis. 2015 Oct;74(10):e59. doi: 10.1136/annrheumdis-2015-207800. Epub 2015 Aug 7.
  • Ceserani V, Ferri A, Berenzi A, Benetti A, Ciusani E, Pascucci L, Bazzucchi C, Coccè V, Bonomi A, Pessina A, Ghezzi E, Zeira O, Ceccarelli P, Versari S, Tremolada C, Alessandri G. Angiogenic and anti-inflammatory properties of micro-fragmented fat tissue and its derived mesenchymal stromal cells. Vasc Cell. 2016 Aug 18;8:3. doi: 10.1186/s13221-016-0037-3. eCollection 2016.
  • Fellows CR, Matta C, Zakany R, Khan IM, Mobasheri A. Adipose, Bone Marrow and Synovial Joint-Derived Mesenchymal Stem Cells for Cartilage Repair. Front Genet. 2016 Dec 20;7:213. doi: 10.3389/fgene.2016.00213. eCollection 2016. Review.
  • Jannelli E, Fontana A. Arthroscopic treatment of chondral defects in the hip: AMIC, MACI, microfragmented adipose tissue transplantation (MATT) and other options. SICOT J. 2017;3:43. doi: 10.1051/sicotj/2017029. Epub 2017 Jun 7.
  • Karpinski K, Müller-Rath R, Niemeyer P, Angele P, Petersen W. Subgroups of patients with osteoarthritis and medial meniscus tear or crystal arthropathy benefit from arthroscopic treatment. Knee Surg Sports Traumatol Arthrosc. 2019 Mar;27(3):782-796. doi: 10.1007/s00167-018-5086-0. Epub 2018 Aug 20.
  • Koh YG, Kwon OR, Kim YS, Choi YJ, Tak DH. Adipose-Derived Mesenchymal Stem Cells With Microfracture Versus Microfracture Alone: 2-Year Follow-up of a Prospective Randomized Trial. Arthroscopy. 2016 Jan;32(1):97-109. doi: 10.1016/j.arthro.2015.09.010. Epub 2015 Nov 14.
  • Koh YG, Choi YJ, Kwon SK, Kim YS, Yeo JE. Clinical results and second-look arthroscopic findings after treatment with adipose-derived stem cells for knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1308-16. doi: 10.1007/s00167-013-2807-2. Epub 2013 Dec 11.
  • MacFarlane LA, Yang H, Collins JE, Jarraya M, Guermazi A, Mandl LA, Martin SD, Wright J, Losina E, Katz JN; MeTeOR Investigator Group. Association of Changes in Effusion-Synovitis With Progression of Cartilage Damage Over Eighteen Months in Patients With Osteoarthritis and Meniscal Tear. Arthritis Rheumatol. 2019 Jan;71(1):73-81. doi: 10.1002/art.40660. Epub 2018 Nov 29.
  • Marchal JA, Picón M, Perán M, Bueno C, Jiménez-Navarro M, Carrillo E, Boulaiz H, Rodríguez N, Álvarez P, Menendez P, de Teresa E, Aránega A. Purification and long-term expansion of multipotent endothelial-like cells with potential cardiovascular regeneration. Stem Cells Dev. 2012 Mar 1;21(4):562-74. doi: 10.1089/scd.2011.0072. Epub 2011 Jun 17.
  • Randelli P, Menon A, Ragone V, Creo P, Bergante S, Randelli F, De Girolamo L, Alfieri Montrasio U, Banfi G, Cabitza P, Tettamanti G, Anastasia L. Lipogems Product Treatment Increases the Proliferation Rate of Human Tendon Stem Cells without Affecting Their Stemness and Differentiation Capability. Stem Cells Int. 2016;2016:4373410. doi: 10.1155/2016/4373410. Epub 2016 Jan 6.
  • Schiavone Panni A, Vasso M, Braile A, Toro G, De Cicco A, Viggiano D, Lepore F. Preliminary results of autologous adipose-derived stem cells in early knee osteoarthritis: identification of a subpopulation with greater response. Int Orthop. 2019 Jan;43(1):7-13. doi: 10.1007/s00264-018-4182-6. Epub 2018 Oct 3.
  • Striano R. D., Chen H., Bilbool N., Azatullah K., Hilado J., Horan K. Case Study: Non-Responsive Knee Pain with Osteoarthritis and Concurrent Meniscal Disease Treated With Autologous Micro-Fragmented Adipose Tissue Under Continuous Ultrasound Guidance CellR4 2015; 3 (5): e1690
  • Tremolada, Carlo. (2017). Mesenchymal Stem Cells and Regenerative Medicine: How Lipogems Technology Make Them Easy, Safe and More Effective to Use. MOJ Biology and Medicine. 2. 10.15406/mojbm.2017.02.00047.
  • Tremolada C, Ricordi C, Caplan AI, Ventura C. Mesenchymal Stem Cells in Lipogems, a Reverse Story: from Clinical Practice to Basic Science. Methods Mol Biol. 2016;1416:109-22. doi: 10.1007/978-1-4939-3584-0_6.
  • Wang X, Jin X, Han W, Cao Y, Halliday A, Blizzard L, Pan F, Antony B, Cicuttini F, Jones G, Ding C. Cross-sectional and Longitudinal Associations between Knee Joint Effusion Synovitis and Knee Pain in Older Adults. J Rheumatol. 2016 Jan;43(1):121-30. doi: 10.3899/jrheum.150355. Epub 2015 Nov 15.

*   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 Suspended
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019) 		75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 12, 2021
Estimated Primary Completion Date August 12, 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
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
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 February 2021

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

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