EVALUATION OF AN INTERSOMATIC BIORESORBABLE LUMBAR CAGE: FUNCTIONAL SITUATION IN THE ANIMAL

Abstract

Purpose: The aim of this work was to evaluate the short- and long-term biocompatibility, tolerance and tissue response after implantation of an intersomatic bioresorbabled lumbar cage (Phusiline®).

Material and methods: Eighteen sheep were operated on in 1999; three animals were sacrificed for study at three, six, nine and twelve months after implantation. The cage was placed between two lumbar vertebrae and filled and covered with cancellous bone. Cerebrospinal fluid, lateroaortic lymph nodes, liver, spleen and kidney samples were taken after sacrifice. The spinal segment from L1 to S1 was removed with the surrounding ligaments and muscles for radiography, MRI, and CT scan. Histology sections were stained with Paragon. The pathology examination included: bone and cell density, degree of tissue differentiation in contact with the implant, remodeling and consolidation of the fusion, implant resorption and associated reactions. An epifluorescence study was performed to assess bone apposition. Reaction of tissue in contact with the implant or far from the implant (laterovertebral muscles, paravetebral lymph nodes, liver, kidney, spleen) were qualified histologically.

Results: At three months, there was no evidence of implant resorption; there was active formation of new bone around the implant. Implant resorption and osteointegration had started at six months and bone remodeling around the implant was increased. There were signs of bone fusion within and around the cage. Spondylodesis was effective at nine months with bone apposition. Implant resorption continued. Spondylodesis was confirmed. After nine and twelve months implantation, there was no sign of local or general intolerance. Degradation of the implants was visible after one month and appeared to be most marked at 12 months. Approximately 30% of the initial surfaced area of the implants had been resorbed at 12 months.

Conclusion: One year after implantation, the implant had not induced any sign of local intolerance (no sign of inflammation, necrosis, osteolysis). Fusion occurred within and around the case. This study will be pursued (two groups of three animals will be sacrificed at 24 and 36 months) and should confirm the long-term effectiveness of this technique.