GRAFTYS® QUICKSET

About

GRAFTYS® QUICKSET is a patented phosphocalcic macroporous injectable hardening resorbable cement. Its physicochemical structure provides advanced osteoconductive properties adapted to Trauma surgery. GRAFTYS® QUICKSET features high viscosity and excellent cohesiveness to address surgical situations with significant blood flow to help ensure good stabilization of bone fragments. This cement facilitates resorption/substitution by mineralized healthy bone and thus limits the risk of fibrosis enc apsulation and seroma syndromes. The short initial setting time (8 min) avoids losing per operative time and reinforces the cohesiveness properties of the material.

Composition

The powder mineral phase is a gauged mix of calcium phosphates including an organic phase (HPMC) which confers wettability and porosity to facilitate percolation of the body fluids throughout the implant and improves the cohesion, elasticity, rheological properties, and injectability. The liquid phase (sodium phosphate solution) facilitates mix homogenization and setting time management (crystallization) of the cement.
After complete hardening the final product is apatite crystals similar to native bone crystals.

Physicochemical properties

Global Porosity 70% distributed as below:
• Micro porosity (<10 µm): 88%;
• Meso porosity ([10 - 100 µm]): 2%;
• Macro porosity (>100 µm): 10%
Available Initial Porosity measured after complete hardening (24h) at 37 °C (98°F body temperature) in biological conditions (Ringer's solution).

• No shrinkage during the crystallization process
• Non exothermic reaction: 1-3 °C
• Mechanical compressive strength: 24MPa (24 hours after implantation). This product has to be used in an intrinsic stable site or in association with material which will stabilize the surgical site.
• Cohesiveness: Excellent resistance to fluid.

Preparation

GRAFTYS® QUICKSET provides an easy, closed mixing system (which eliminates the messy bowl/spatula). Ring on injection end of syringe is shipped in "Closed" position. To initiate mixing, hold injection end upright and rotate ring to "Transfer". Press fluid into the powder side. Mix thoroughly for 2 minutes. Rotate ring to "Inject" and inject the material directly by hands or with injection gun. (Cf. synoptic of preparation)
• Mixing time (room temperature): 2 min
• Injection time (room temperature): 2-4 min
• Low sensitivity to temperature variations of a functional operating theatre
• Diameter of usable cannulas: ≤7 Ga
• Initial setting time (37°C -98°F body temperature- in biological conditions): 8 min
• Complete hardening (37°C -98°F body temperature- in biological conditions): 24 hours

Mechanism of action

GRAFTYS® QUICKSET is a macroporous injectable hardening resorbable cement. The mineral part allows the formation of a close bond with the native bone. The implant is gradually resorbed by cells participating in the natural bone remodeling cycle. Conduction and formation of mineralized healthy bone is thereby ensured as quick as the material resorbs without voids formation (overly rapid dissolution can lead to fibrosis). The organic part confers wettability and porosity to facilitate percolation of the body fluids throughout the implant and improves the cohesion, elasticity, rheological properties, and injectability.

Features