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BIO-SPACER

BIO-SPACER




GENERAL


The BIO-SPACER ® is a temporary modular implant, designed for the replacement of infected hip prosthesis by mean of a two stages surgical technique, according to a detailed plan. This implant allows the surgeon to adjust it to the patient anatomy for the femur as well as for the head. As a matter of fact, the BIO-SPACER ® is composed of a stem, available in various length and sizes, and of a head, also available in various diameters.



DESCRIPTION






         


- The Femoral stem is reinforced with stainless steel heart, (AISI 316L), coated with a pmma bone cement of high resistance (strength).
- Head in PEHD, in which 4 small tanks of 1 cc will allow the surgeon to adjust the antibioterapic treatment (drug therapy).
- These tanks are sealed by a small hole which allows the setting of drug into them and from which there will be the slow release of drugs when implanted.
- It is strictly asked to use the supplied enclosed needle for the filling of these tanks: the use of needles of various diameters is strictly prohibited.



TRIAL IMPLANTS


                 



                 

         Thanks to trial implants of various lengths and sizes, as well as for the femoral
         or head parts, the surgeon is able to fit perfectly to the patient anatomy and case.
         The surgeon studies and works out the optimal implant's combination, adapted for
         the surgical site.



SURGERY TECHNIQUE


Any of surgical way allows the BIO-SPACER ® surgery and implantation.

- When the infected prosthesis is withdrawn, prepare carefully the bone situ, take out all the remainings of late bone cement particles.
- High pressure washing of the surgical site.
- Use the trial stems to select the right size to the femoral canal.
- As soon as this trial stem is in place, select the trial head fitting with the patient anatomy.
- Set up this head onto the stem already in place, reduce it within the acetabular cavity.
- If the tests in tension, length and non luxations are met, take the final implants which are equivalent to the selected trial implants.
- Should the tests ask for a more stable solution, draw out the first trial implants and do again the tests with other trial implant parts to find out the right combination.
- When the choice is finally fitting with the anatomy, select the final implants.
- Set up the final stem into the femoral diaphysis.
- Take the relative head and the surgeon will then fill each tank with the right antibiotic treatment for the patient infection.
- Set up the head onto the stem, (the link is done by impacting the morse taper) then reduce it within the acetabular cavity.



ADVANTAGES


- Many sizes are available for the best adjustment of the patient anatomy.
- The capacity to add many antibiotic or sedative analgesic substances is unic and very innovative.
- The right and perfectly adapted antibiotic treatment will meet efficiently the infection germs, thanks to the antibiotic tanks.
- The drug release was studied to spread a large quantity of drugs into the site at the beginning for the efficiency (flash effect), and then a progressive locale diffusion within the time.
- Muscular work in between to avoid the amyothophia.
- Patient is quickly able to walk on partial and painless upright support (Two crutches are necessary to move after the first day of surgery)*

*(The surgeon must appreciate the anatomical conditions, bony quality and the clinical circumstances during the period of rehabilitation. Care must be taken to minimize the risk of damaging bone tissue and the implant through excessive weight bearing or forced mobilization).

- On economic point, a quick return at home is also a main factor for the good psychological state of the patient.
- Easy removal of the BIO-SPACER ® at the second operating step, which avoids :

                                                   . fibrosis                                                   
                                                      . retraction
                                                       . bad position

- No luxation: The BIO-SPACER ® has a complete range to be perfectly adapted to surgical condition.



RELEASED CURVE





SIZE & REFERENCE




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