Artikel
Early clinical results using a new interlaminar device (INTRA Spine) in lumbar D.D.D.
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Autoren
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G. Guizzardi
- Neurosurgical Department, University and City Hospital Careggi, Florence, Italy
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P. Petrini
- Orthopaedic Department, City Hospital, Città di Castello, Perugia, Italy
| Veröffentlicht: | 30. Mai 2008 |
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Gliederung
Text
Objective: All interspinous systems presently available create, even if in different degrees, a significant reduction of the flexion-extension and, to a lesser degree of the bending and axial rotation. Furthermore, they are distant from the IAR.
Methods: We present a new device for interlaminar assistance in the degenerative pathologies of mobile lumbar segments. The device, made of medical silicone (75/80 shore) with a polyethylene terephthalate coating, has an advantage with respect to other similar interspinous devices, which is that it may be implanted more anteriorily (interlaminar) and therefore as close as possible to the center of istantaneous rotation of the segment.
Furthermore, with this device, it is possible to restore the physiological lumbar lordosis, thanks to the augmentation of the supraspinous fibrous complex by means of a robust artificial ligament that is passed around the two adjacent spinous processes.
A surgical instrument, created ad hoc, allows us to perform the procedure with a mininvasive monolateral approach and with the maximum anatomical respect for the structures.
The indications are:
- Black disc-facet syndrome
- Soft and/or foraminal stenosis
- Lumbar canal stenosis after decompression (no laminectomy)
- Large dimension lumbar disk herniations in young patients
- Topping-off (to prevent the junctional pathology)
Results: The first results (100 implants) seem promising, even though taken after a short follow-up.
Compared to the pre-operative controls performed with CT scan, dynamic X Ray and MRI, these identical post-operative examinations demonstrate that the physiological movement of the motion segment that was previously altered, is now restored.
The clinical results are evaluated by VAS and Oswestry.
Conclusions: We think we can say that the interlaminar devices, seen as they closer to the IAR, help re-create a ROM that is very similar to the physiological one, and therefore opens the way to a new and improved possibility of motor preservation in the surgical treatment of the degenerative lumbar spine pathology.
We are so satisfied with the first clinical results that we decided to begin an international randomized study in a few months which is controlled by an independent observer to validate the use of this new device.
