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Corticosteroid
Lipogems Injection for Osteoarthritis
N/A
Waitlist Available
Led By Dustin Richter, MD
Research Sponsored by Dustin L. Richter, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to procedure then post-procedure at 2 weeks
Awards & highlights
Study Summary
This trial will study a new procedure (Lipogems) to reduce knee joint pain in patients with osteoarthritis. It will compare Lipogems to a placebo & intra-articular corticosteroids, hoping to reduce pain & improve joint functionality.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prior to procedure then post-procedure at 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to procedure then post-procedure at 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Visual Analog Pain Scale (VAS) Over Time
Secondary outcome measures
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Over Time
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Over Time
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Lipogems InjectionExperimental Treatment1 Intervention
Patients who are randomized to the Lipogems treatment group will undergo a lipoaspiration from their abdomen and autologous injection of the harvested adipocytes into their knee. It is standard to harvest three to four times more adipose tissue than is planned to be injected to account for tissue processing by the Lipogems device. The investigators plan to inject 7cc of autologous adipose tissue. Thus, the investigators will harvest between 25 and 30 cc of adipose tissue from each patient. The tissue will be processed immediately and 7cc will be injected. Any remaining adipose tissue will be disposed of immediately in biohazardous waste.
Group II: Corticosteroid InjectionActive Control1 Intervention
Patients who are randomized to the corticosteroid group will receive an injection of 2cc (80mg) of triamcinalone acetonide injectable suspension mixed with 5 cc of 1% plain lidocaine for a total of 7cc of fluid injected in the affected knee.
Group III: Placebo InjectionPlacebo Group1 Intervention
Patients who are randomized to the placebo group will receive an injection of 7cc of sterile saline in the affected knee.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Microfragmented Adipose Tissue (Lipogems)
2018
N/A
~80
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Who is running the clinical trial?
Dustin L. Richter, MDLead Sponsor
Dustin Richter, MDPrincipal InvestigatorUNM Health Sciences Center, Dept of Orthopaedic Surgery
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