Abstract
The safety of nucleus implants remains an open issue in the treatment of intervertebral disc degeneration. Post-operative migration and subsequent extrusion represent a high risk of potential unsatisfactory outcome. The effectiveness of additionally sewing a biointegrative nucleus implant into an annulus defect was investigated therefore in this experiment.
Laminectomy preserving the facet joints was performed on seven human functional spinal units (FSU’s). A reproducible annulus defect of 6×6 mm was incised, followed by a standard nucleotomy procedure and subsequent introduction of the implants. These woven patches consist of biointegrative, absorbable polyglycolic acid (PGA), lyophilized with hyaluronic acid. The annulus sealing technique requires placing a PGA-patch adjacent to the inner annulus, fixed by sutures (Polysorb 3-0, Syneture) at its four corners. Unsealed annulus defects served as a control group. FSU’s were loaded with a bending torque of 5 to 7.5 Nm. Continual revolution of the specimen around its vertical axis resulted in a combination of lateral, dorsal and flexural bending. During application of loads, implant herniation level was determined every 1 000 cycles according to predefined criteria. Tests were stopped after reaching 20 000 cycles.
Five of totally six sewed specimens withstood 20 000 load cycles, whereas only one of five not sewed specimens terminated successfully. Based on the Mann-Whitney test, significant increase in stability can be detected for the sewed procedure.
Sewing a biointegrative annulus implant into an annulus defect improves nucleus implant containment. It remains to be shown whether this annulus sealing technique is also effective in highly degenerated annulus tissue. Furthermore, a minimally invasive implantation device is crucial for application in a clinical setting.
Correspondence should be addressed to EORS Secretariat Mag. Gerlinde M. Jahn, c/o Vienna Medical Academy, Alserstrasse 4, 1090 Vienna, Austria. Fax: +43-1-4078274. Email: eors@medacad.org
