Bone defects are common and occur in many clinical situations including high grade open fractures with bone loss, high energy trauma, blast injuries, infection requiring debridement of bone, and resection of bone tumors or cysts.

There is a significant burden of disease associated with the management of bone defects, particularly if the bone defect is critical sized or when the planned reconstruction requires secondary surgery and autogenous bone grafting, often complicated by drawbacks such as donor site morbidity, limited graft volume, anesthesia time, need for additional surgical resources, and poor results in a significant number of patients.

A huge number of challenges can be solved with the latest addition to curasan’s orthobiologic portfolio, CERASORB® CPC Bone Void Fillers.

Reasons for CERASORB® CPC
Bone Void Fillers

Regenerative biomaterial
❯ resorbed by cell-mediated processes and replaced by endogenous bone
❯ steady remodeling process
❯ radio-opaque 
Precise in application
❯ self-setting in aqueous environment no setting in applicator syringe
❯ complete setting and hardening after
❯ contact with aqueous body fluids 
Provides structural support
❯ highly cohesive calcium phosphate cement
❯ high compressive strength (up to 45 MPa)
❯ supports osteosynthesis by increased stability 
Saves time and effort
❯ no mixing or preparation
❯ ready-to-use
❯ easy-to-use 
Packaging, storage and transportation
❯ syringe is contained in a sterile double blister within a protective cardboard box
❯ stored at temperatures between 5° C and 25° C (room temperature recommended)  
❯ transport validation up to 55° C. 
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EASY TO FOLLOW
PRODUCT HANDLING

❯ 01 Open and assemble

Open blister with the pre-filled syringe and the Tyvek pouch with the spindle drive (spindle nut and threaded spindle) and the PE-bag with the cannula. Push the spindle nut onto the syringe until a clear click sound is heard. Check that both sides of the spindle nut are locked.

❯ 02 Insert and adjust the spindle

Insert the threaded spindle into the spindle nut. Screw the threaded spindle in the spindle nut until it is in direct contact with the piston.

❯ 03 Adjust setting and application

Shorten the application cannula if needed. Attach the application cannula if necessary. By slowly turning the spindle clockwise, CERASORB® CPC can be applied to the bone defect.

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.
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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. 
LEARN MORE ABOUT THE INDICATIONS

CASE REPORTS
INDICATIONS

CERASORB® CPC’ s are is an orthobiological, biomineral bone cements for regenerative bone augmentation. The biodegradeable and self-setting calcium phosphate cements 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).

Download IFU CERASORB® CPC

CASE REPORTS
Clinical case examples

University Hospital Regensburg, Germany. Department of Trauma Surgery
Lateral tibial plateau fracture left tibia, type Schatzker V

 

❯ 01-02 Pre-operative X-rays of tibial plateau fracture, type Schatzker V
❯ 03 Open reduction of lateral tibial plateau left and bone defect filling with CERASORB® CPC
❯ 04-05 Day 1 post-operative x-rays.
❯ 06 6 months post-operative x-rays.
❯ Clinical follow-up.

❯ CERASORB® CPC was easy to handle during the operation and allowed sufficient bone defect filling.
❯ 6 months post-operative, X-rays showed complete fracture healing with osseous integration and initial degradation of CERASORB® CPC.  No subsidence of the articular surface could be observed.
❯ CERASORB® CPC supports the defect through good osseous integration and is gradually replaced by the newly formed bone. 

University Hospital Regensburg, Germany. Department of Trauma Surgery
Ankle fracture type WEBER C with bony defect of distal fibula

❯ 01-02 Pre-operative X-rays of ankle fracture type WEBER C with bony defect of distal fibula
❯ 03 Day 1 post-operative x-ray. Open reduction and filling of the fibula defect with CERASORB® CPC
❯ 04-05 10 weeks post- operative X-rays.
❯ Clinical follow-up.

❯ CERASORB® CPC was easy to handle during the operation
and allowed sufficient bone defect filling.
❯ 10 weeks post-operative, X-rays showed complete fracture healing
with beginning of osseous integration of CERASORB® CPC.
❯ CERASORB® CPC supports the defect through good osseous
integration and is gradually replaced by the newly formed bone.

EMPOWERING BONE HEALING PRODUCTS
CERASORB® β-TCP
BONE REGENERATION MATERIALS

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CERASORB®
Features and
Benefits

❯ CERASORB® is a purely synthetic Bone Regeneration Material (BRM) with a phase purity of > 99% (contains less than 1% HA), which is referenced as the global ICDD gold-standard. There are no infection risks with CERASORB®.

❯ CERASORB® contains a well desinged and defined microporous sintering structure, that avoids particle break-up when used correctly. The primary particle size is < 63µm (d50= 10µm) to avoid phagocytosis and to be aligned with the natural bone resorption and remodelling ratio.

❯ The micro-, meso- and macropores of CERASORB® provide fast integration of vital cells, a high release of Calcium ions during resorption through hydrolytic corrosion and contribute to the transformation of osteoblasts to osteocytes.

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