Leírás

PROPRIETARY TECHNOLOGY – METHOD OF ACTION

CERASORB® CPC is a synthetic composition of biomineral powders and a non-aqueous carrier liquid. The components form a cohesive, viscous bone graft substitute that transforms into a microcrystaline calcium deficient hydroxyapatite after a self-setting process.

CONSISTENCY & COMPRESSIVE STRENGTH

 

 

 

Once the setting process is initiated, the compressive strength of CERASORB® CPC increases continuously. Just 10 minutes after injection, a hard outer shell covers the pasty core, enabling the surgeon to immediately place an osteosynthesis implant such as plates and screws. As early as 16 to 24 hours after injection, the compressive strength is similar to that of cancellous bone. Final compressive strength is achieved after about 96 hours (depending on the volume/geometry of the filled bone defect and the supply of body fluid). At this point, the compressive strength of CERASORB® CPC is three to four times higher than with healthy cancellous bone.

 

 

PHASE EVOLUTION

 

 

 

After initiation of the crystallization process, the chemical composition of CERASORB® CPC adapts to the surrounding bone. By means of an X-ray diffraction analysis carried out over the complete course of the setting reaction, this reaction can be clearly verified. After about seven days, the analysis shows a continuous change to low-calcium hydroxyapatite. The similarity between human bone (red line) and the chemical composition and crystalline structure of CERASORB® CPC (purple lines) is clearly evident seven days after implantation.

 

 

COHESION & DEFECT FILLING

The release of particles during the setting reaction of a bone substitute cement is significantly influenced by the cohesion. Accordingly, during the development of CERASORB® CPC, care was taken to minimize particle release to below 2 % after injection in water. Thus, even in the case of screw augmentation, CERASORB® CPC fills the entire defect and remains completely in the bone cavity instead of flowing back along the screw from the tip to the head or leaking out under the screw head.

RADIO-OPACITY

The high mineral density of CERASORB® CPC makes it more visible under the fluoroscope. This makes it easier to follow and adjust the flow of the calcium phosphate cement.

INDICATIONS

CERASORB® CPC is an orthobiological, biomineral bone cements for regenerative bone augmentation. The biodegradeable and self-setting calcium phosphate cement are indicated for filling bone defects, reinforcing temporary osteosynthesis fixation and filling or reconstructing non-load-bearing bone defects.

The scope of application includes, but is not limited to:

❯ metaphyseal defect fractures, (such as fractures of the tibia, radius and humerus).
❯ bone defects following resection (such as of benign tumors and cysts)
❯ bone defects after removal or replacement of osteosynthetic implants
❯ support for the fixation of osteosynthetic implants (such as bone screws)

CERASORB® CPC must only be used on well-vascularized and non-infected bone sites. Correct repositioning and stabilization of fractures by means of suitable fixation must also be ensured.

(For the complete list of indications and contraindications, please refer to the current version of the Instructions for use).