Refractory Shoulder Pain with Osteoarthritis, and Rotator Cuff Tear, Treated With Micro-Fragmented Adipose Tissue

Richard D Striano1*, Gerard A Malanga2, Norma Bilbool3, Khatira Azatullah4

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Abstract

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.

Non-Responsive Shoulder Pain with Osteoarthritis and Rotator Cuff Tears Treated With Autologous, Micro-Fragmented and Minimally Manipulated Adipose Tissue Under Continuous Ultrasound Guidance

R.Striano, G. Malanga, J. Bowen, N. Bilbool, K. Azatullah, J. Hilado

ABSTRACT

Background: Orthopedic pain from osteoarthritis (OA) and rotator cuff disease affect a large portion of the adult population. The result is pain, reduced range of motion, impairment in activities of daily living and a worsening quality of life. Currently, there are limited treatments if non-operative care fails. In this context, the autologous fat graft is gaining interest. Fat is readily accessible and simple to harvest, to provide volume, cushion, structural support, repair and replacement of damaged tissues. In addition, fat graft is a heterogeneous mix of cellular and non-cellular elements that produce trophic cascades.

Objective: To study the safety and benefits of using an autologous, minimally manipulated adipose tissue graft for treating degenerative shoulder pathology with pain having failed conventional care.

 Study description: To remove variables in assessing outcomes of the fat graft exclusively, no other biologics or pharmacologics were introduced with the treatment. 18 subjects (19 shoulders) reached one-year follow-up, which was part of an ongoing IRB study approved by IRCM (Institute of Regenerative and Cellular Medicine).  Two subjects were lost to follow up prior to one year.  The patients were ages: 39 – 89 with moderate to advanced degeneration. Tears (all confirmed on MRI): Glenohumeral Osteoarthritis: Severe n=10, moderate n=8. Acromio-clavicular arthrosis: n=8. Rotator Cuff: Supraspinatus: Full thickness tears n=8, complete tear n=2, partial thickness tears n=7, tendinosis n=8, fatty atrophy n=5. Infraspinatus: Tendinosis n=6, full thickness tear n=1.  Subscapularis: Tendinosis n=4, intra-substance tear n=1. Labrum: Tear n=7. Bicep tendon: Tendinosis n=1, partial thickness tear n=4.

Material and Methods: An autologous, mircofragmented, fat graft was obtained using a minimal manipulation technology in a closed system, without the addition of enzymes or other additives.

The graft was injected in 1cc aliquots under continuous ultrasound guidance, into each joint and/or each tendon / soft tissue defect.  Clinical outcomes are shown in Fig. 1-7.

 Results: Other than pain consistent with multiple injections, no adverse events were reported. The improvement of the symptoms occurred within a few days after treatment and all measured scores (symptoms, signs, and function) showed significant improvement to one-year follow-up (NPS p<0.0001, ASES p<0.0002, Constant p< 0.0006. Figures 1-7).

 Conclusion: Although more investigation is needed, these results show promise where other methods have failed. The injection of autologous, micro-fragmented, and minimally manipulated adipose tissue appears very effective in patients with shoulder disease that failed conventional treatments.