A Randomized, Multi-center, Double Blind, Parallel Study to Examine the Effect of Lipogems Processed Microfragmented Adipose Tissue in Comparison to Corticosteroid for the Treatment of Knee Osteoarthritis
Overview
- Phase
- Phase 3
- Intervention
- Corticosteroid
- Conditions
- Knee Osteoarthritis
- Sponsor
- Lipogems International spa
- Enrollment
- 173
- Locations
- 18
- Primary Endpoint
- Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to examine the effect of a single autologous, intra-articular injection of MFat versus corticosteroid injection for the treatment of pain and function associated with K/L grade 2/3 knee Osteoarthritis.
Participants will receive an injection of MFat or a corticosteroid.
Detailed Description
This study will investigate The Lipogems System in a clinical study to examine the effect of micro fragmented adipose tissue processed using The Lipogems System in comparison to corticosteroid for the treatment of knee osteoarthritis. This study will be randomized and double-blinded. The subjects will be randomized at a 2:1 ratio (investigational to control) and will enroll 173 patients at up to 20 sites in the United States.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, participants must meet all of the following criteria:
- •Age ≥ 18 years old at the date of screening
- •Have both clinical and radiographic findings consistent with osteoarthritis of the knee:
- •Participant has clinical findings including (but not limited to) tenderness to palpation, swelling/effusion, stiffness, chronic limited range of motion.
- •Participant has a diagnosis of knee OA defined as Grade 2 to 3 by (K/L) weight bearing X-ray and physician review within the past 3 months.
- •The index knee must present with symptomatic knee pain using WOMAC-A Visual Analog Scale (VAS) of 40mm or greater despite conservative therapies for 3 months prior to enrollment:
- •a. Failure of conservative therapies include the following: Participants must have failed a minimum of at least 3 months, including (1) physical therapy, and (2) oral OTC pain medications such as an NSAID (Aleve® or Advil®) or Acetaminophen (Tylenol®), or a prescription NSAID, for a period of 90 days at the Maximum Tolerable Dose according to the respective manufacturer's instructions on dose and duration, or their physician's over-riding guidance. Patients who are unable to tolerate this dosing regimen for 90 days, or those in whom NSAIDS or Acetaminophen are contraindicated, shall be deemed to have satisfied this inclusion criteria.
- •Willing to give written Informed Consent to voluntarily participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) Authorization prior to study participation
- •Ability to return for multiple follow-up visits
- •Ability read and understand English language
Exclusion Criteria
- •Participants who meet any of the following criteria will be excluded from participating in this study. Study eligibility of participants reporting isolated use of prohibited medications during the restricted periods defined by this protocol, will be evaluated on a case-by-case basis by the medical monitor.
- •Diagnosis of knee OA defined as K/L grade 1 or
- •BMI greater than 35 kg/m
- •Diagnosis of rheumatoid arthritis, psoriatic arthritis, or any other disorder which attributes to the primary source of their knee pain, including but not limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.
- •Presence of any clinically observed active infection including in the index knee joint, infection at the site of adipose tissue harvest, and/or any active systemic or local infection.
- •Undergone injection in target knee within 6 months prior to screening visit, including but not limited to corticosteroids, hyaluronic acid (HA), bone marrow concentrate (BMAC) platelet rich plasma (PRP), human cellular exosomes, amniotic fluid or any human birth tissue.
- •Undergone surgical procedures of either knee within 6 months prior to the screening visit.
- •Bilateral knee pathology can only be treated in one knee for the study. The contralateral knee must have a WOMAC-A Visual Analog Scale (VAS) pain score of no more than 20mm for the past 3 months prior to enrollmentat the time of screening (48-hr recall).
- •Index knee greater than 10 degrees varus/valgus deformities (anatomic tibiofemoral angle).
- •Knee pain associated with osteochondritis dissecans, ligament damage or displaced meniscus tear.
Arms & Interventions
Corticosteroid Injection
The cases assigned to this group will be injected intra-articularly in the knee with a corticosteroid. It will be administered once at the baseline visit of the study.
Intervention: Corticosteroid
Microfragmented Adipose Tissue (Mfat)
Injection of Microfragmented Adipose Tissue derived using Lipogems® Kit The cases assigned to this group will be injected intra-articularly with Lipogems®. The patients will undergo lipoaspiration of their own adipose tissue for Mfat then this Mfat will be injected intra-articularly in the knee. It will be administered once at the baseline visit of the study.
Intervention: Microfragmented Adipose Tissue
Outcomes
Primary Outcomes
Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score
Time Frame: 12-month visit
The change from baseline to Month 12 for the Western Ontario and McMaster Universities Osteoarthritis Index pain (WOMAC-A) subscale score (superiority); Scale = 0-100, where 100 is extreme pain
WOMAC-C Subscale Score
Time Frame: 12-month visit
The change from baseline to Month 12 for the Western Ontario and McMaster Universities Osteoarthritis Index function (WOMAC-C) subscale score (non-inferiority), scale 0-100, where 100 is extreme difficulty performing a function.
Secondary Outcomes
- Change in WOMAC-C Function Sub Score(12-month visit)
- Change in Total WOMAC scores(12-month visit)
- Change in WOMAC-A Pain Sub Score(12-month visit)