06.01 Bone cement

BONE CEMENT IS USED FOR CEMENTATION AND FIXATION OF BONES. IT IS INTENDED FOR FILLING
AND STABILIZATION OF BONE DEFECTS AS PART OF INTERNAL FIXATION TREATMENT.
EACH BONE CEMENT CONSISTS OF TWO COMPONENT SYSTEMS, SUCH AS POWDER AND LIQUID.

COMPOSITION
A package of bone cement of standard viscosity contains one bag of cement powder and one glass ampoule of monomeric liquid.

    Powder formula 40 g
    Methyl polymethacrylate 36.16 g
    Barium sulfate 3.50 g
    Benzoyl peroxide 0.34 g
    Liquid formula 20 ml
    Methyl methacrylate 19.84 ml
    N, N-dimethyl p-toluidine 0.16 ml
    Hydroquinone 20 ppm

PREPARATION AND APPLICATION
– sterile work area;
– sterile bowl made of ceramic, stainless steel, polypropylene or other material specifically approved for contact with bone cement dough;
– sterile spoon or spatula made of ceramic, stainless steel, polypropylene or other material specifically approved for contact with bone cement dough.

Only after confirming the integrity of the package does the assistant open the outer blister and remove the inner blister containing the bag and ampoule, keeping it sterile.
The inner blister can be applied to a sterile work surface. The bag and ampoule should only be opened under absolute sterility, immediately before preparing the bone cement and subsequent application. The dose is prepared by pouring the entire contents of the ampoule of the liquid component into a bowl containing the entire amount of powder included in one bag.

OPENING UNDER STERILE CONDITIONS:
– Open the outer PE paper bag in a designated area under sterile conditions to ensure that the inner PE paper bag remains sterile when removed. Also, open the blister pack at the designated point under sterile conditions to ensure that the glass vial remains sterile when removed.
– Before opening the inner PE paper bag, move the contents downward by shaking or tapping to ensure that no powder is lost when the bag is cut at the top. To facilitate opening the glass ampoule, a predetermined break point is provided when moving to the ampoule head.
– Do not open the ampoule above the mixing device to prevent glass fragments from contaminating the cement.
– The 20 ml ampoule is equipped with a removal device (tube) to facilitate the opening procedure. If this is the case, take the attached device instead of the ampoule head and break the ampoule head above it. When the ampoule head comes off, it remains inside the tubing.

THE PREPARATION AND APPLICATION OF BONE CEMENT IS APPLIED IN THE FOLLOWING FOUR PHASES:
1. MIXING.
2. WAITING
3. BREEDING
4. APPLICATION.

STIRRING:
It is recommended to measure the liquid first and then add the powder. If this order is not followed, moth nests are more likely to form as a result of polymerization starting directly on the surface.Both components, i.e. the relative proportions of powder and monomer, are exactly the same. Therefore, if an optimal mixture is to be achieved, the bag and ampoule should be completely emptied.

The cement components must be placed in the mixing bowl immediately before mixing.Filling and mixing should always be carried out under sterile conditions. The mixing time is 30 seconds. During this time, both components are mixed evenly. The result is a homogeneous pulp. Always mix the powder polymer completely with the monomer liquid ampoule.
When preparing and applying bone cement, higher temperatures accelerate curing and lower temperatures slow it down.
– Stir regularly, not too fast, and continue for one minute. Do not exceed the mixing time.
– The viscosity gradually increases due to the polymerization reaction during phases II to IV.
– Continue to wait until phase II is complete (waiting phase) and then proceed with application (phase III, cement has become a dough).

For other additional information, indications, contraindications, storage conditions, see the instructions