Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis
- Conditions
- Knee OsteoarthritisOsteo Arthritis Knee
- Registration Number
- NCT06121882
- Lead Sponsor
- Lipogems International spa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 173
Inclusion Criteria:<br><br> - In order to be eligible to participate in this study, participants must meet all of<br> the following criteria:<br><br> 1. Age = 18 years old at the date of screening<br><br> 2. Have both clinical and radiographic findings consistent with osteoarthritis of<br> the knee:<br><br> 1. Participant has clinical findings including (but not limited to)<br> tenderness to palpation, swelling/effusion, stiffness, chronic limited<br> range of motion.<br><br> 2. Participant has a diagnosis of knee OA defined as Grade 2 to 3 by (K/L)<br> weight bearing X-ray and physician review within the past 3 months.<br><br> 3. The index knee must present with symptomatic knee pain using WOMAC-A Visual<br> Analog Scale (VAS) of 40mm or greater despite conservative therapies for 3<br> months prior to enrollment:<br><br> CONFIDENTIAL Page 12 of 52 Version 2.0, 10JUL2023<br><br> a. Failure of conservative therapies include the following: Participants must<br> have failed a minimum of at least 3 months, including (1) physical therapy, and<br> (2) oral OTC pain medications such as an NSAID (Aleve® or Advil®) or<br> Acetaminophen (Tylenol®), or a prescription NSAID, for a period of 90 days at<br> the Maximum Tolerable Dose according to the respective manufacturer's<br> instructions on dose and duration, or their physician's over-riding guidance.<br> Patients who are unable to tolerate this dosing regimen for 90 days, or those<br> in whom NSAIDS or Acetaminophen are contraindicated, shall be deemed to have<br> satisfied this inclusion criteria.<br><br> 4. Willing to give written Informed Consent to voluntarily participate in the<br> study and sign the Health Insurance Portability and Accountability Act (HIPAA)<br> Authorization prior to study participation<br><br> 5. Ability to return for multiple follow-up visits<br><br> 6. Ability read and understand English language<br><br> 7. Females of child-bearing potential must have a negative urine pregnancy test<br> performed within 7 days of study enrollment or be postmenopausal (for at least<br> 2 years) or surgically sterilized (bilateral tubal ligation, bilateral<br> oophorectomy, or hysterectomy)<br><br>Exclusion Criteria:<br><br> - Participants who meet any of the following criteria will be excluded from<br> participating in this study. Study eligibility of participants reporting isolated<br> use of prohibited medications during the restricted periods defined by this<br> protocol, will be evaluated on a case-by-case basis by the medical monitor.<br><br> 1. Diagnosis of knee OA defined as K/L grade 1 or 4.<br><br> 2. BMI greater than 35 kg/m2.<br><br> 3. Diagnosis of rheumatoid arthritis, psoriatic arthritis, or any other disorder<br> which attributes to the primary source of their knee pain, including but not<br> limited to: osteonecrosis, radiculopathy, bursitis, tendinitis, tumor, cancer.<br><br> 4. Presence of any clinically observed active infection including in the index<br> knee joint, infection at the site of adipose tissue harvest, and/or any active<br> systemic or local infection.<br><br> 5. Undergone injection in target knee within 6 months prior to screening visit,<br> including but not limited to corticosteroids, hyaluronic acid (HA), bone marrow<br> concentrate (BMAC), platelet rich plasma (PRP), human cellular exosomes,<br> amniotic fluid, or any human birth tissue.<br><br> 6. Undergone surgical procedures of either knee within 6 months prior to the<br> screening visit.<br><br> 7. Bilateral knee pathology can only be treated in one knee for the study. The<br> contralateral knee must have a WOMAC-A Visual Analog Scale (VAS) pain score of<br> no more than 20mm at the time of screening (48-hr recall).<br><br> 8. Index knee greater than 10 degrees varus/valgus deformities (anatomic<br> tibiofemoral angle).<br><br> 9. Knee pain associated with osteochondritis dissecans, ligament damage or<br> displaced meniscus tear.<br><br> 10. Current or historical autoimmune disease that requires immunosuppressive<br> medication.<br><br> 11. Any disorder affecting musculoskeletal pain and/or function, including<br> symptomatic OA of the back, hips, or ankle that would interfere with the<br> evaluation of the treated knee.<br><br> 12. Planned or expected surgery within the next 12 months.<br><br> 13. Allergy to lidocaine, epinephrine, or valium.<br><br> 14. Diagnosis of HIV or viral hepatitis.<br><br> 15. Use of oral systemic corticosteroids within the last 90 days and for the<br> duration of the study.<br><br> 16. History of any chemotherapy or radiation therapy of the targeted/treatment leg<br> or adipose harvest site.<br><br> 17. Active worker's compensation case.<br><br> 18. Diagnosis of coagulation disorders (e.g., Von Willebrand's disease) and/or<br> currently on anti-coagulant therapy.<br><br> 19. Occurrence of knee trauma to the index knee within six months prior to<br> screening.<br><br> 20. Unwilling to stop usage of over-the-counter pain medication (e.g.,<br> Acetaminophen or NSAID), Rescue Analgesics, for 7 days prior to any follow-up<br> visit, with the exception of one baby aspirin per day for cardiovascular<br> therapy or prophylaxis.<br><br> 21. Unwilling to stop taking prescription pain or prescription anti-inflammatory<br> medication for the duration of the study, with the exception of Tramadol during<br> the immediate post-procedure period noted below.<br><br> 22. Unwilling to abstain from NSAIDS for 7 days pre-injection and 2 weeks<br> post-injection. Tramadol is allowed during the 72 hours immediately<br> post-injection, with diary documentation of usage.<br><br> 23. Currently taking prescription pain medication for a condition other than the<br> index knee.<br><br> 24. Currently in prison.<br><br> 25. Untreated symptomatic injury of the index knee (e.g., acute traumatic injury,<br> anterior cruciate ligament injury, clinically symptomatic meniscus injury<br> characterized by mechanical issue such as locking or catching).<br><br> 26. Impossibility to harvest enough adipose tissue.<br><br> 27. Any medical issue that the clinician feels would be a contraindication to the<br> study treatment including, but not limited to:<br><br> 1. Uncontrolled diabetes defined as HbA1c >7%,<br><br> 2. History of uncontrolled hypertension defined by average systolic BP >140<br> mmHg or diastolic BP > 90 mmHg on = 3 blood pressure medications,<br><br> 3. History of cardiovascular disease,<br><br> 4. History of cerebrovascular disease,<br><br> 5. Uncontrolled asthma, defined as symptomatic (i.e., shortness of breath<br> and/or wheezing) despite therapy,<br><br> 6. History of solid organ or hematologic transplantation,<br><br> 7. Diagnosis of non-basal cell malignancy within preceding 5 years,<br><br> 8. Change in prescription medication within 1 month prior to enrollment,<br><br> 9. Clinically significant abnormalities in vital signs at the time of<br> screening defined by<br><br> - Systolic BP >140 or <90
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score;Change in WOMAC-C (function) Subscale Score
- Secondary Outcome Measures
Name Time Method Change in WOMAC-A Pain Sub Score;Change in WOMAC-C Pain Sub Score;Change in Total WOMAC scores