Safety and Efficacy of Percutaneous Injection of Lipogems Micro-Fractured Adipose Tissue for Osteoarthritic Knees

STUDY PRESENTATION

This report details the outcome of an IRB-approved study of 17 subjects with 26 symptomatic knees with a history of knee OA (Kellgren–Lawrence grade of 3 or 4) diagnosed by a radiograph. Patient demographics are described in the Table.

_{Abbreviation: BMI, body mass index.}

The study patients were evaluated by an orthopedic surgeon, Mitchell Sheinkop, who commonly performs total joint replacement in his practice and considers potential patients as candidates for TKA. These patients presented with a Kellgren-Lawrence grade of 3 or 4 knee OA, and all had significant pain that was refractory to conservative treatment, which included medications, physical therapy, and injections. The study patients were offered the Lipogems procedure as an alternative to TKA. Following this procedure, the study subjects were clinically evaluated using the numerical pain rating scale (NPRS), the 100-point Knee Society Score (KSS) with its functional component (FXN), and the lower extremity activity scale (LEAS) at 6 weeks, 6 months, and 12 months. The 1989 KSS12 was used for this study. Adverse reactions were also monitored throughout the study period.

METHODS

After obtaining informed consent, the subjects were taken into the operating room, moved to the procedure table, and placed in the prone position for aspiration. After scrubbing with Betadine and draping, 1 mL of lidocaine was used to anesthetize the skin, and a pre-prepared preparation of lidocaine, epinephrine, and sterile saline was infused into the subcutaneous tissue. The micro-fragmented adipose tissue was obtained with minimal manipulation using Lipogems, a closed system using mild mechanical forces and reduction filters. The system processes the lipoaspirate without the addition of enzymes or any other additives. The final product consists of adipose tissue clusters with preserved vascular stromal niche of approximately 500 microns. The lipoaspirate was processed in the same room via a closed system. During the processing, the subject’s puncture wounds were dressed. The knee injection site was prepped with a Betadine swab and DuraPrep. Then, Lipogems was injected intra-articularly under ultrasound guidance.

After the completion of the injection, manual range of motion was administered to the treated joint. The subject was then transferred to the recovery room where vital signs were monitored. Post-procedure instructions were reviewed with the patient by the study staff. The subject was instructed to use an assistive device and avoid weight-bearing for 48 hours and maintain the activities of daily living to a minimum on the day of the procedure. Non-weight-bearing for 48 hours was recommended for reducing discomfort to avoid the use of opioids. Nonsteroidal anti-inflammatory drugs, alcohol, and marijuana must be avoided for 4 weeks after the procedure. Pretreatment and post-treatment outcomes were collected using the NPRS, the 100-point KSS with its FXN, and the LEAS at 6 weeks, 6 months, and 12 months after this procedure. The 1989 KSS12 was used for this study since the same scale was used for previous TKA procedures by our authors, allowing for future comparisons of results.

STATISTICAL ANALYSIS

Mean and standard deviation were used to estimate central tendency and variability. Outcome measures were analyzed using the t test, with the pairwise t test was used for paired and subsequent measurements of the same patient or a knee. All analyses were performed with significance set at P <.05. The minimal clinically important difference (MCID) in patients who underwent TKA for primary OA was between 5.3 and 5.9 for KSS, while the MCID for FXN was between 6.1 and 6.4.13 These values were referenced for our analysis.

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