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Why Sacrix chose HAP-TCP Resorbable Blast Media (RBM) Surface Coating

January 20, 2023

by Dr. Kingsley R Chin MD MBA and Dr. Jason A Seale MBA

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SacroFuse Sacroiliac Joint Screws feature a surface texture enhanced by Resorbable Blast Media (RBM) coating. The RBM treatment effectively roughens the implant surface, leaving no residual embedded blast particles or debris. This surface enhancement is pivotal, as it enables SacroFuse to achieve unparalleled osseointegration. By elevating the success rate of Bone to Implant Contact (BIC), it facilitates seamless bone integration around the implant while concurrently reducing the risk of post-surgery infections. Additionally, the RBM process bolsters retention strength, further enhancing the efficacy of SacroFuse.

The precise topography achieved through RBM coating, down to the micrometer scale, exerts a profound influence on the attachment and growth of new bone cells. This effect is characterized by accelerated and more stable bone cell growth. The RBM coating process incorporates Hydroxyapatite (HAP) and TriCalcium Phosphate (TCP), both known for their exceptional resorbable and biocompatible properties, which significantly aid in bone formation.

What sets this process apart is the use of Calcium Phosphate as the blasting material, eliminating the necessity for harsh acids to remove residual blasting material remnants. Consequently, the RBM surface technology yields outstanding osseointegration with an almost negligible chance of disruption. Even in the rare event of particle disruption, these particles are entirely biocompatible, fostering early bone in-growth and heightened implant stability during the crucial initial weeks following sacroiliac joint screw placement.

HAP-TCP RBM Coating

Top 3 Properties

  • Complies with standards: ASTM F1185 and F1088

  • Composition : Pure biphasic HA 85% / TCP 15% 

  • Particle size : 250-560µm, 160-250µm, 160-400µm ; 75-160µm ; 25-75µm

Top 3 Advantages

  • 100% biocompatible media forming an optimal surface morphology

  • Excellent solubility of the grains

  • Achievable roughness range for pure Ti and Ti alloy substrates: Ra > 2.0µm

In summary, the RBM (Resorbable Blast Media) technology encompasses both blasting and gentle etching of the screw surface. Its key advantages include:

1) Utilization of biocompatible blasting shots that can be easily removed, leading to the creation of an ideal surface morphology.

2) Incorporation of a soft chemical treatment, ensuring a high degree of surface cleanliness with no potential for particle contamination or surface damage.

References

About Sacrix LLC

Sacrix LLC, a distinguished member of the KICVentures Group portfolio, is dedicated to pioneering a revolutionary percutaneous fluoroscopic lateral-oblique transfixation technique for sacroiliac joint fusion, primarily aimed at addressing sacroiliac dysfunction and sacroiliitis. Sacrix has ingeniously developed the patented Sacrofuse variable threaded implant, designed for percutaneous insertion, and received FDA clearance for its use in 2015.

Distinguishing itself further, the Gen1 Sacrofuse implant was subjected to a head-to-head comparison with the market leader SI bone (SIBN) and demonstrated an astonishing 400% increase in pull-out strength. This attests to the exceptional durability and performance of the Sacrofuse implant.

Sacrix has also undertaken the critical task of training over 200 interventional pain physicians, orthopedic surgeons, and neurosurgeons. Their goal is to enable these medical professionals to safely and effectively perform the groundbreaking Sacrix SIJ fusion technique through a minimally invasive 1.5 cm incision, all within the confines of outpatient ambulatory surgery centers. This commitment to training underscores Sacrix's dedication to improving patient outcomes through advanced surgical approaches.

About the Author

Dr. Kingsley R. Chin MBA is a board-certified Professor of Orthopedic Spine Surgery and honors graduate of Harvard Medical School, the Harvard Combined Orthopedic Residency Program and Harvard Business School for leadership. He did his spine fellowship with Dr. Henry H Bohlman. He was Chief of Spine Surgery at the University of Pennsylvania.

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