Design Rationale

Design Rationale

Shaping the Future of Bone Repair: The Science of Bone Formation

Use of bone graft substitutes can improve clinical outcomes and allow for more rapid and predictable bone formation.  These materials are commonly used alone or in conjunction with autogenous bone graft.  An ideal graft material contains four properties:

  1. Osteoconductivity (OC) – provides a 3-D matrix to host migrating bone cells and a structural lattice for mechanical load sharing.
  2. Osteoinductivity (OI) – promotes the proliferation and differentiation of stem cells into mature bone forming cells.
  3. Osteogenesis (OG) – provides and/or recruits precursor cells that participate in the early stages of healing, uniting the graft to host bone.
  4. Durability – must keep all OI, OC and OG constituents in place during lavage and irrigation, while remodeling occurs.

Composite grafts not only provide for ease of use, confidence, clinically proven constituents and flexibility; they eliminate the following concerns associated with autograft harvesting1:

  • Autograft donor site complications
  • Procurement morbidity
  • Disability
  • Chronic pain at graft site
  • Cell death once separated from blood supply
  • Donor-site infection

Historically, doctors relied on autograft to provide for the osteoconductive, osteoinductive and osteogenic elements required in bone formation, yet not without complications. Today, an optimal bone graft provides for these elements and eliminates the concerns associated with harvesting autograft. Our composite grafts offer maximum efficiency with enhanced site retention, optimal demineralized bone matrix (DBM) concentrations, flexible mixing options and an ideal performance that autograft does not offer. A composite graft that optimizes bone repair and regeneration with clinically proven constituents and eliminates concerns associated with autograft provides “A Great Day in the O.R.”

Our Composite Grafts Offer…

  1. Osteoconduction: At Exactech, we developed a refined recipe to include a combination of cortical and cancellous bone chips that are optimally sized, shaped and 100 percent densely packed to provide the mandatory three-dimensional scaffold required for the attachment, migration and distribution of osteogenic cells.
  2. Osteoinduction: We studied different concentration levels of DBM to carrier and looked for those levels of DBM that provided for the optimal new bone formation. Only DBM that has been tested in-vivo and scored using histology is used in our composite grafts. Every lot is tested in-vivo.
  3. Osteogenesis: Our composite grafts are delivered and stored in a dry powdered form, lyophilized to maintain the bioactivity of the material. The grafts can then be hydrated at the time of surgery with autologous diluents to provide for new bone growth.
  4. Osteocompatibility: To prevent migration or wash out of the DBM, we have developed inert delivery systems that retain the bone forming constituents at the intended graft site.
All of our bone graft products have received 510(k) clearance as medical devices.

 

References

1. Seiler JG, Johnson J, Hand G. Illiac crest autogenous bone grafting: donor site complications. J South Orthop Assoc 2000;9(2):91-7

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