Richard D Striano1*, Gerard A Malanga2, Norma Bilbool3, Khatira Azatullah4
Background: Chronic shoulder pain and rotator cuff abnormalities affect a large portion of the population and result in substantial impairments and loss of useful functions, thus affecting patient quality of life. One of the most common causes of shoulder pain in the adult population is osteoarthritis. It is the third most prevalent musculoskeletal disorder after low back and neck pain. If current standard non-operative methods fail, there are few viable options available other than shoulder replacement surgery. Recently biological treatments using adult stem cell treatments, mesenchymal stem cells (MSC’s) have been shown to have potential benefits in orthopedic applications. One such source of regenerative cellular tissue is adipose, which is known to be a robust source of stem cells. Adipose tissue is readily accessible, easily harvested and few complications have been reported. This study embarks on reporting the safety, efficacy and long term benefits from ultrasound guided injection of an autologous, minimally manipulated, microfragmented adipose tissue.
Materials and Methods: Material and Methods: An explanation of the treatment was provided and informed consent obtained. The micro-fragmented adipose tissue was obtained with minimal manipulation using Lipogems® (Lipogems USA, Atlanta Ga.) a closed system using normal saline cleansing, mild mechanical separation of waste products and reduction filters. The system provides a 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 injections were delivered into the joint and each soft tissue abnormality under direct ultrasound guidance as was found to be clinically relevant. Numeric pain scores and The American Shoulder and Elbow Surgeons Score (ASES) were collected immediately following treatment, and at weeks 1 and 5, months 3, 6 and 12.
Results: Significant improvement was noted through all time points to one year. Outcomes assessed immediately following treatment, at weeks 1 and 5, months 3, 6 and 12 by Numerical Pain Scale (NPS) and The American Shoulder and Elbow Surgeons Score (ASES). NPS (p<0.00008), ASES (p< 0.00017). The average improvement of NPS was from 7.5 to 3.6 at one year. The average ASES from 33.7 to 69.2 at one year (0-100 scale 100 perfect function). No post procedural complications or serious adverse events were reported.
Conclusions: While the limitations of this study are a low number of subjects and not a randomized controlled trial, it is noteworthy that most published studies are shorter term follow up 3-6 months. The results from this study demonstrate significant improvements in pain, function and quality of life as represented by positive outcomes in all measured scores through twelve months.