Mechanical supplementation by non-rigid fixation in degenerative intervertebral lumbar segments: the Wallis system.

A first-generation implant for non-rigid stabilization of lumbar segments was developed in 1986. It included a titanium interspinous blocker and an artificial ligament made of dacron. Following an initial observational study in 1988 and a prospective controlled study from 1988 to 1993, more than 300 patients have been treated for degenerative lesions with this type of implant with clinical and mechanical follow-up. After careful analysis of the points that could be improved, a second-generation implant called the "Wallis" implant, was developed. This interspinous blocker, which was made of metal in the preliminary version, is made of PEEK (polyetheretherketone) in the new model. The overall implant constitutes a "floating" system, with no permanent fixation in the vertebral bone, to avoid the risk of loosening. It achieves an increase in the rigidity of destabilized segments beyond normal values. The clinical trials of the first-generation implant provided evidence that the interspinous system of non-rigid stabilization is efficacious against low-back pain due to degenerative instability and free of serious complications. The first-generation devices achieved marked, significant resolution of residual low-back pain. These results warrant confirmation. A randomized clinical trial and an observational study of the new implant are currently underway. Non-rigid fixation clearly appears to be a useful technique in the management of initial forms of degenerative intervertebral lumbar disc disease. This method should rapidly assume a specific role along with total disc prostheses in the new step-wise surgical strategy to obviate definitive fusion of degenerative intervertebral segments. At present, the Wallis system is recommended for lumbar disc disease in the following indications: (i) discectomy for massive herniated disc leading to substantial loss of disc material, (ii) a second discectomy for recurrence of herniated disc, (iii) discectomy for herniation of a transitional disc with sacralization of L5, (iv) degenerative disc disease at a level adjacent to a previous fusion, and (v) isolated Modic I lesion leading to chronic low-back pain.