Osteo Arthritis Knee
Conditions
Keywords
Osteo Arthritis Knee, Autologous Adipose Tissue
Brief summary
Evaluating the safety and efficacy of a single injection of autologous adipose tissue for treatment of osteoarthritis of the knee.
Detailed description
This clinical trial is a single site, double blinded, paired within groups, controlled clinical study to investigate the safety and efficacy in the use of adult autologous adipose tissue for the treatment of pain associated with joint OA. The hypothesis of this trial is that the treatment will be safe and the proposed clinical outcome measures of reduced pain resulting from the treatment of OA of the knee joint with autologous adipose tissue will be superior to a placebo control treatment.
Interventions
OTHERInjection of Autologous Adipose Tissue
Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis
OTHERInjection of lactated ringers
Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.
Sponsors
Aestique Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patient and treating physician are both blinded, being that neither are aware of which knee received the autologous adipose tissue injection and which knee received the placebo lactated ringers injection
Intervention model description
Double blind parallel groups assignment
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Bilateral K-L Grade II through Grade IV osteoarthritis as diagnosed by physician review of weight bearing X-ray or MRI excluding subjects whose knee pain is caused by, (i) diffuse edema, (ii) displaced meniscus tear, (iii) lesion greater than 1 cm in any direction, or (iv) osteochondritis dissecans. 2. Study Participants must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed. 3. Males and females 40-75 years old. 4. Participants will be in good health (ASA Class I-II) with a BMI \< 35. 5. Continued pain in the knee despite conservative therapies for at least 6 months. 6. Participants must present with a bilateral knee pain scores ≥6 and ≤16 using the short-form WOMAC pain (A1 subscale, 20 total points). 7. Must speak, read and understand English. 8. Subjects must be reasonably able to return for multiple follow-up visits.
Exclusion criteria
1. Participants who have had surgery of either knee within 6 months prior to the screening visit. 2. Participants who have had a major injury to either knee within 12 months prior to enrolling in the study. 3. Participants who have had an injection in either knee in the prior 6 months, including corticosteroids, viscosupplementation or platelet rich plasma (PRP). 4. Participants who have gout, rheumatoid arthritis, lupus arthropathy, psoriatic arthritis, avascular necrosis, severe bone deformity, infection of the knee joint, fibromyalgia, pes anserine bursitis, or neurogenic or vascular claudication. 5. Participants who have symptomatic OA of the hips, spine, or ankle that would interfere with the evaluation of the treated knee. 6. Participants that are unwilling to stop taking prescription pain medication 7 days prior to any visit. 7. Participants that are allergic to lidocaine, epinephrine or valium 8. History of bleeding disorders, anticoagulation therapy that cannot be stopped 3 days prior to injection 9. Subjects that use any form of tobacco to include e-cigarettes more than once a week within the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Incidence of Treatment-Emergent Adverse Events | 6 months | Subjects will be monitored for adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Change in Pain Scores on the WOMAC Scale at All Follow-Up Visits | 1 week, 6 weeks, 3 months, and 6 months | Patient outcomes for pain will be recorded |
| Efficacy - Change in Function Scores on the WOMAC Scale at All Follow-Up Visits | 1 week, 6 weeks, 3 months, and 6 months | Patient outcomes for function will be recorded |
| Efficacy - Change in Stiffness Scores on the WOMAC Scale at All Follow-Up Visits | 1 week, 6 weeks, 3 months, and 6 months | Patient outcomes for stiffness will be recorded |
Other
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Change in Function Scores on the VAS Scale at All Follow-Up Visits | 1 week, 6 weeks, 3 months, and 6 months | Patient outcomes for function will be recorded |
| Efficacy - Change in Stiffness Scores on the VAS Scale at All Follow-Up Visits | 1 week, 6 weeks, 3 months, and 6 months | Patient outcomes for stiffness will be recorded |
| Efficacy - Change in Pain Scores on the VAS Scale at All Follow-Up Visits | 1 week, 6 weeks, 3 months, and 6 months | Patient outcomes for pain will be recorded |
Countries
United States
Outcome results
None listed