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Why ?

A In the long run, i.e. after twenty years, polyethylene, despite tribology progresses, will unavoidably result in osteolysis, metal metal friction cause potential local or general toxicity risks. Any incident, dislocation, impingement, three bodies wear may release large quantities of chrome and cobalt. Although very small quantities of chrome and cobalt are tolerated by the body, large quantities are highly toxic. Cobalt is eliminated through the urine, but chrome is not or little eliminated, and builds up in the body. The long term consequences of such a build up cannot be forecasted.

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Alumina head surface ( 1 micron )

Acetabular implant design

In light of the lessons drawn from the use of solid alumina ceramic implants, with or without metal back, it seems advisable to insert the ceramic cup, the female element of the unit, in a PE core..

Combining both materials helps take advantage of the undisputed advantages of some of PE's properties.

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    • PE helps soften and spread stress
    • With PE, the ceramic cup edge can be covered and protected, preventing a possible conflict with the neck of the femoral prosthesis
    • In the event of an installation with a metal back ring, the PE core and its ceramic insert is installed precisely, without any misplacing risk
    • The PE inserted between the ceramic and the metal back is subjected to little stress: the stress is spread over larger surfaces.

     

    Polyethylene stress transmission is different with an all polyethylene cup and with a sandwich cup. The head sends loads to spots, which concentrates the stress and leads to creeping. In the event of a sandwich, the alumina cup transmits broad loads to the polyethylene, and the better stress distribution reduces the polyethylene deterioration risks. The alumina cup is inserted in the polyethylene core by hot crimping.

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    The spreading of the stress helps reduce creeping risks significantly.

    The PE is not in contact with the head, and therefore is not subjected to any friction.

    In such conditions, the use of PE helps take advantage of PE's properties while preventing its deterioration and serious resulting problems.

    The minimum polyethylene thickness is 5 mm. The polyethylene is UHMW and reticulated in order to provide increased break resistance, as in this instance, there is no need to increase the friction resistance, since none of the polyethylene will be subjected to friction.
    The quality and resistance of the crimping has been tested. The alumina cup resistance and that of the polyethylene have also been tested..

     

     

    Laboratory tests

    The Burst test consists in applying a force to a head placed in the cup, which is held in a support with a 25 % angle. No fracture of the alumina or polyethylene cup or metal back was observed under a 100 kn load equivalent to a 10 ton load.

    Burst test

    The Lever out test was used to check the resistance to a rotation torque exerted on the edge of the alumina cup. The lever out test resistance was 3 295 N

    Lever out test

    The push out test exerts a force in the head axis on the alumina cup embedded in a polyethylene core placed on a flat basis, without any metal back and any peripheral support. This test showed a 2300 N resistance.

     

    Push out test

     

    Lastly, the torsion test, which exerts a rotation on the axis of the alumina cup, showed resistance to a force of 2200 N per centimetre.

    Torsion test

     

    The burst tests is rather similar to the forces exerted in a hip, and the resistance to a 10 ton + load is much higher than any usual stress.

    The lever out test could simulate a conflict between the cup neck and edge (impingement), prevented by the polyethylene edge and the end-of-operation testing we describe below.

    The Push out test corresponds to the barely imaginable absence of metal back or bony support.

    The Torsion test is satisfactory, since the particularly low alumina alumina friction torque is much less than the required 220 kg per cm for mobility.

    All the values above are much higher than human clinic conditions, and therefore are highly reliable.

    Technical requirements

    * The special impactor for alumina alumina FH acetabulum provides support all around the core in the polyethylene section, not at the centre on the alumina. The use of this impactor is mandatory as any impaction on the alumina cup using a conventional impacter would weaken the cup.

    * As a remainder, for the metal back, the cup surroundings need to be cleared before impacting the core, in order to prevent any conflict between the insert and soft tissues that could interfere.
    * Impingement, a conflict between the femoral neck and the edge of the cup, fearsome with all types of prosthesis, regardless of the friction combination. It stresses the acetabulum anchoring and results in debris. Impingement in metal metal and ceramic ceramic friction is all the more fearsome when the neck wears out in contact with the cup edge, weakens, may break and release metal debris.
    That is why we have added a polyethylene edge on the acetabulum insert, which comes between the neck and the cup automatically in the event of impingement.

     

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    As a reminder, like for any prosthesis, great care should be taken in placing the femoral and acetabulum prosthesis parts and in checking, at the end of the operation, the absence of neck-cup contact in maximum positions, especially in forced external extension-rotation.

    It is essential to use a perfectly compatible alumina alumina combination and therefore strongly inadvisable to mix both parts : it is safe to use the alumina alumina combination delivered by FH-Orthopedics or by distributors, which guarantees compatibility.

    Welcome - The various Atlas - Primary stability - Insert stability - Insert thickness - Secondary stability - Alumina/Alumina - Explant analysis
    Low-friction - Surgical procedure - Clinical data - Quality requirement - The inventor - Contact - International distribution