With SpineJack®, you get a controlled cranio-caudal expansion, a maintenance of the height restoration and a trabecula preservation. With Balloon Kyphoplasty, you have no control during multidirectional balloon expansion; the hydraulic inflation controls pressure but not height and you have an unpredictable inflation path, which follows the least resistant path. Moreover, there is no height maintenance with a limited restoration and a potential recollapse just before cement injection. Lastly, no trabecula preservation with the creation of a void in the vertebral body and no interdigitation of cement: creation of cement marble, potentially less stabilization.
It is needed to check the correct position of the implant in the vertebra before its expansion, the implant once open cannot be closed again. Since the implant cannot be closed again after opening, it is imperative to open it once it is in the correct position in the vertebral body.
If the surgical technique is followed, and no steps skipped, the surgeon will have three positioning steps to verify the correct placement:
All three steps MUST be checked in both the AP and lateral views.
The implant is made of a titanium alloy, Ti6Al4V, according to standards ISO 5832-3 and ASTM F136.
The SpineJack® system is indicated for use in the reduction of mobile spinal fractures that may result from osteoporosis, trauma (fractures types A according to the Magerl classification) and malignant lesions myeloma or osteolitic metastasis.
The SpineJack® implant is available in 3 diameters and the product range allows to cover 95% of VCF (potentially from T5 to L5, depending on type of patient, fracture).
SpineJack® can be used for VCF in patients with traumatic injuries and good bone quality, used in combination with Interface™ Bone Fixation Composite (recommended).
SpineJack® can be used in tumor cases: malignant lesions myeloma or osteolitic metastasis. Benefits compared to Vertebroplasty are: height restoration and restoration maintenance to decrease the risk of fracture on the adjacent vertebrae, recurrent and/or progressive kyphosis and disc degeneration.
Once the cement has hardened, yes.
The main difference is the 50% HA composing Interface™ Bone Fixation Composite and the PMMA percentage ratio.
Yes, Trauma Registry with 2 year follow-up is a solid proof regarding this point as it includes patients with traumatic injuries in good bone quality.
Interface™ Bone Fixation Composite is a non bioresorbable cement. Meanwhile with his unique composition of 50% Hydroxyapatyte (30% PMMA and 20% Zr02) Interface™ Bone Fixation Composite has osteoconductivity properties which enhances biocompatibility for bone tissue apposition.