CopiOs® Bone Void Filler

Providing an environment for optimal bone growth 1

The CopiOs Bone Void Filler Sponge alone is an osteoconductive bone graft substitute; the addition of autologous bone marrow aspirate (BMA) provides osteogenic and osteoinductive properties necessary for bone growth. The moderately acidic composition of CopiOs Sponge (calcium phosphate dibasic) creates an environment where an abundance of soluble mineral is available and osteoinductive bone morphogenic protein (BMP) is preserved. These features, together with a highly porous collagen scaffold provide elements required to maximise the healing processes for bone production and maturation.

  • High soluble calcium and phosphate concentrations
  • High porosity collagen scaffold
  • Bone forming cells
  • Endogenous growth factors

In conclusion, composite grafts of synthetic bone grafts substitutes and bone marrow aspirate have proven to be effective alternatives to autograft. 2,3,4

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An effective autograft alternative

* CopiOs Sponge provides the benefits of autograft without the limitations

* No need for second surgical procedure to harvest graft

* Readily available with consistent quality

* Combined with autologous bone marrow aspirate, provides the three requisite properties for bone growth:

  1. Osteoconductive
  2. Osteogenic
  3. Osteoinductive

* Pre-clinical studies show CopiOs Sponge to be biocompatible and non-toxic

* CopiOs Sponge was nonimmunogenic in animal studies

* Pre-clinical studies with CopiOs Sponge plus bone marrow aspirate show bone healing performance equivalent to autograft

Autograft limitations

Autograft is widely regarded as the ideal construct for graft procedures, supplying osteoinductive growth factors, osteogenic cells, and a structural scaffold.3 It also has the benefits of no disease transmission or graft rejection. However, autograft has its limitations:1,3

*Requires second surgical procedure associated with increase costs

  • Longer OR and recovery times
  • Greater blood loss
  • Extended hospital stays

*Limited bone supply and often issues with bone quality, especially in the elderly

*Donor site morbidity

*Major complications (25%-29%)1 have been reported including disabling chronic pain at donor site

There are documented risks associated with the surgical harvest of the iliac crest including:1

  • Infection
  • Chronic, severe pain
  • Gait disturbances
  • Neurologic and vascular damage
  • Herniation of muscle and abdomen
  • Pelvic fracture or instability

CopiOs Sponge strength performance

Mechanical property evaluations: Rabbit radial critical size defect model, 11 weeks5

CopiOs Sponge with BMA was equivalent to autograft in failure torque and torsional rigidity testing.

CopiOs Sponge bone growth performance

Radiographic analysis: Rabbit radial critical size defect model, 11 weeks 5

CopiOs Sponge with BMA was equivalent to autograft showing cortical rim formation at 11 weeks.

Histologic analysis: Rabbit radial critical size defect model, 12 weeks, low-power 6x magnification5

CopiOs Sponge with BMA shows trabecular bone formation at 12 weeks equivalent to autograft.

The Next Generation in synthetic bone graft materials

CopiOs Sponge contains calcium and phosphorus which are primary constituents of natural bone

A unique mineral chemistry that contains no tricalcium phosphate or hydroxyapatite

Calcium phosphate, dibasic provides over 200 times more soluble calcium and phosphate at equilibrium than either tricalcium phosphate or hydroxyapatite (Fig. 1)

Fig. 1: Equilibrium solubilities for calcium salts5

Fig. 2: Concentration of BMP-2 in a calcium salt solution 5

CopiOs Sponge provides an acidic environment that promotes solubility of endogenous growth factors (Fig. 2)

Thus, more soluble BMPs may remain available in the early stages of bone formation

The concentration of BMP-2 in a solution decreases substantially when HA or TCP is present (Fig. 2)

Collagen scaffold has approximately 93% porosity with interconnecting, multi-directional pores ranging in size between 5-1000μm to allow for rapid, complete absorption of autologous fluids (Fig. 3)

Three-dimensional structure resembles human cancellous bone

Combined, these attributes promote cellular attachment, nutrient and oxygen infiltration and vascularization throughout the graft material

Fig. 3: Microscopic view of collagen scaffold

Non-chemical cross-linking provides strength and durability for the scaffold to persist until replaced by bone in-growth

Alone, CopiOs Sponge is an osteoconductive bone graft substitute; with the addition of bone marrow it provides the osteogenic and osteoinductive elements essential for bone growth

As new bone growth occurs, the scaffold is resorbed

It resorbs more quickly than hydroxyapatite and allows for better imaging and visualisation of the healing process

References

1 Szpalski M, Gunzburg R. Applications of calcium phosphate-based cancellous bone void fillers in trauma surgery. Orthopedics. May 2002; 25(5 Supp):S601-S609.

2 Chapman MW, Bucholz R, Cornell C. Treatment of acute fractures with a collagen-calcium phosphate graft material: a randomized clinical trial. J Bone Joint Surg (Am). 1997; 79:495-502.

3 Betz RR. Limitations of autograft and allograft: new synthetic solutions. Orthopedics. May 2002; 25(5 Supp):S561-S570.

4 Vaccaro AR. The role of the osteoconductive scaffold in synthetic bone graft. Orthopedics. May 2002; 25(5 Supp):S571-S578.

5 Data on file at Zimmer, Inc.