Article
New model of bone reconstruction specially designed for skull base surgery. Long-term testing in primates
Neues Knochenrekonstruktionsmodell nach Schädelbasisoperationen-Langzeitstudie an Primaten
Search Medline for
Authors
Published: | April 11, 2007 |
---|
Outline
Text
Objective: The direct endonasal or transoral transclival approaches to the skull base permits effective minimally invasive surgery along the clivus region. Developing consistently effective techniques to prevent cerebrospinal fluid (CSF)-leaks and their consequences (infections and healing processes with long and complicated recoveries) remain a major challenge. In this study we tested a method of bone reconstruction newly developed by us, which makes use of a specially designed elastic silicone plug and can be used for bone replacement after minimally invasive skull base surgery without risks of postoperative CSF leaks.
Methods: After an acute testing of plug efficiency in a pig model, whose results showed a 100% closure of the bone defect without CSF-leak, we tested the long-term efficiency of the plugs in 3 primates. We used an endoscope-controlled transoral transclival approach and simulated a CSF-leakage after opening the dura. We inserted the plug into the bone defect and closed the mucosa of the oral cavity with stiches. The follow-up includes blood-, CSF-, weight-, and wound control 1, 4 and 8 weeks after operation. Social behavior such as reintegration and postoperative eating abnormalities were also studied. The target points of this study was to examine: 1) The biocompatibility of the material, 2) Development of infection against the foreign body, 3) Growth behavior of the plug on the surrounding bone, 4) Development of CSF-leakages in the early and late postoperative phase.
Results: Infection was not seen in CSF and blood testings. The wound healing was normal. The social behavior of the animals in the early postoperative phase and during the 2 months follow-up was excellent and without any eating or weight abnormalities. CSF leakages was not developed. The histological examination of the clivus bone showed no abnormalities.
Conclusions: This novel medical device allows an easy, fast and uncomplicated use. It enables leak-proof closure of bone defects after minimal invasive craniotomies like the transclival approach; no additional surgery or other therapies are necessary.