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Trinity ELITE®

Description

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DESCRIPTION​​​

Trinity ELITE, a third generation allograft with viable cells, provides a unique alternative to autograft, long considered the standard for bone grafting. Exclusively processed for Orthofix by our premier partner, the Musculoskeletal Transplant Foundation (MTF), Trinity ELITE builds on the exemplary safety profile of more than 175,000 Trinity Evolution® and Trinity ELITE procedures to date. Trinity ELITE offers an enhanced handling experience, while providing a viable grafting alternative supplying the three physiologic and essential components for robust bone formation:

  • Osteoconductive scaffold
  • Verified osteoinductive potential​​
  • A reliable number of cells retained within the bone matrix1

In addition to these three essential elements for robust bone formation, Trinity ELITE provides the unique feature of being fully moldable by the user.​

Trinity ELITE is processed by MTF, a nonprofit organization dedicated to providing quality tissue. Each step in the processing of Trinity ELITE is designed to maximize the health and viability of mesenchymal stem cells (MSCs) and osteoprogenitor cells ​(OPCs). Research shows that MSCs decline with age, and as cells age, there are changes in differentiation and regeneration capacity.2  In Trinity ELITE, cell health begins with quality cells:

  • Strict donor screening standards
  • Time-sensitive processing and controlled-rate of freezing for optimal cell viability
  • Cryopreservation and storage in vapor-phase liquid nitrogen at -185˚C
  • Expiration dating that reflects real-time testing and must pass MTF's stringent release criteria​

Footnotes

  1. Data on File (MTF).
  2. Caplan, Al. The Mesengenic Process. Clin Plast Surg, 1994 Jul; 21(3); p.429-35.

Indication

Trinity ELITE is an allograft intended for the treatment of musculoskeletal defects.

Clinical References

Clinical References

  • Bostrom MPG, and Seigerman DA. The clinical use of allografts, demineralized bone matrices, synthetic bone graft substitutes and osteoinductive growth factors: A survey study. 2005. HSS Journal 1(1):9-18.
  • Pacaccio DJ, and Stern SF. Demineralized bone matrix: Basic science and clinical applications. 2005. Clin Podiatr Med Surg 22:599-606.

Non-Clinical References​

  • Seo, B.M., et al., Recovery of stem cells from cryopreserved periodontal ligament. J Dent Res, 2005. 84(10): p. 907-12.
  • Woods, E.J., et al., Optimized cryopreservation method for human dental pulp-derived stem cells and their tissues of origin for banking and clinical use. Cryobiology, 2009. 59(2): p. 150-7.
  • Wildermann B, Kadow-Romacker A, Haas NP, Schmidmaier G. Quantification of various growth factors in different demineralized bone matrix preparations. 2007. J Biomed Mater Res A 81(2):437-442.
  • ​Caplan, Al. Tsengenic Process. Clin Plast Surg, 1994 Jul; 21(3); p.429-35.​​​

Resources

Instructions for Use