Abstract
Study Design: We describe innovative minimally invasive Israeli made Expandable Spinal Fusion System for lumbar spinal fusion, in patients with all caused of mechanical back pain: Degenerative Disc Disease (DDD) at one or two levels from L2–S1, up to Grade l spondylolysthesis. The purpose of the study was to provide a preliminary evaluation of the safety and efficacy of the Expandable Spinal Fusion System in establishing vertebral stability and fusion, and in improving the quality of life of the patients.
The relatively large diameter of currently used cages dictates extensive manipulations, damaging structures that are crucial for spinal stability.
The Expandable Spinal Fusion System, is 5 mm in diameter in closed configuration, applied in a minimally invasive technique, through a 6mm entering opening by an open or percutaneous posterior procedures. Once in position, its dimensions are increased to a precut size in a controlled procedure. Thus, this system maintains the integrity of facet joints, with no or minimal laminectomy, and minimal damage to the surrounding tissues.
Methods: Data were collected in a series of 60 patients with DDD in levels L3–S1. The patients wee operated in the open posterior approach with or without Pedicle Screws and percutaneous posterolateral. Both end-plates faces were treated by special curettes and partially removed. Posterior iliac bone graft was used and 2 tubes device were introduced to the inter-somatic space under direct vision controlled by X-rays C-Arm intensifying magnification.
Data: The implantation approach was posterior in 52 patients, anterior in 2 and percutaneous in 6 patients. Maximal follow up period is 12 months. Patients follow up was completed according to investigational protocol mandate follow up visit at 1.5, 3, 6, 12 months postoperatively. The main at the time of the surgery was 52 years old. 57 underwent surgery at one level as follows: 3 at L3-L4, 32 at L4-L5, and 21 at L5-S1, and 3 underwent surgery at two levels.
Patient questionnaire pain and quality of life was evaluated using the Oswestry questionnaire and VAS measurement. The patient fill those pre-operatively and at each follow up visit.
Results: Although follow up period is short according to preliminary data, the Expandable Spinal Fusion System has proved to be safe, effective, as well as easy to handle for treating all cases of mechanical back pain: DDD. There was no neurological injury, no infection, no death and no worsening of clinical symptoms. There was no breakage or migration of the implant at the last follow-up. Flexion-Extension X-ray show good stability. VAS score for pain dropped from 8 pre op to 2.6 in average 3 months post-op.
The abstracts were prepared by Orah Naor. Correspondence should be addressed to him at the Israel Orthopaedic Association, PO Box 7845, Haifa 31074, Israel.
