[Alternative bone replacement substances for preoperative design of individual CAD/CAM skull implants]. / Alternative Knochenersatzmaterialien zur präoperativen Fertigung individueller CAD/CAM-Schädelimplantate.

BACKGROUND: The preoperative manufacturing of individual skull implants using computer aided design (CAD) and computer aided manufacturing (CAM) is based on the use of titanium, although the use of other materials is also potentially possible. THE USE OF OTHER MATERIALS: The use of poly-(D,L-lactide) (PDLLA) as an implant material was investigated using an adult, formalin fixed sheep's head with a complex frontolateral defect. A standard individual titanium implant as well as a resection template made of aluminium were milled in order to allow bone resection and reconstruction within one operation. A mould was made of Teflon for the fabrication of the PDLLA implant using carbon dioxide at high pressure. This procedure allowed a critical comparison to be made of both implant materials and showed that the production of a biodegradable PDLLA implant is possible. At present the titanium implant is superior to the PDLLA implant, as PDLLA settled with slightly larger dimensions than the mould, although the structure itself was exact. DISCUSSION: The goal of the present research is the fabrication of a functionally graded material made of polylactide, polyglycolide, calcium phosphate and osteoinductive proteins using existing technology, which will meet all of the requirements for stability, resorption kinetics, biocompatibility, radiotranslucence and osteogenic potency of an ideal implant material.

Degradation kinetics of biodegradable DL-polylactic acid biodegradable implants depending on the site of implantation.

A recently developed biodegradable system made of DL-polylactic acid (DL-PLA) for internal fixation of non-weight-bearing bones of the craniofacial skeleton was investigated. The plates were used for rigid fixation of experimental nasal bone fractures in 20 New Zealand white rabbits. In addition, prebent plates were placed in subcutaneous pockets in the backs of the animals. The material was removed after 7, 14, 28, and 42 days, and bending angles, plate stability, molecular weights (MW), and histologic analyses were studied. A significant decrease of MW over time and a difference in MW loss, showing a faster degradation subcutaneously, were observed. Plate stability did not decrease during the interval of 6 weeks, but a loss of bending angle was found in all prebent implants. This effect was caused by memory of DL-PLA. The results suggest that memory of biodegradable materials should be investigated before clinical application and that degradation rates differ according to the site of implantation.

Memory of DL-polylactic acid biodegradable plates.

Biodegradable plates and screws have many advantages over metal plates and screws. Plates were injection-molded and made of DL-polylactic acid. Four-hole plates were bent with the use of a heated tip to angles of 30, 45, and 60 degrees. They were inserted in the subcutaneous space in the back of rabbits. After 2 weeks, the plates straightened, suggesting that the plates had a memory. The results were confirmed by similar in vitro investigations. The in vitro experiment was repeated with tempering of the plates. The plates were heated to a temperature of 200 degrees C for 45 seconds, cooled, and then again heated to 200 degrees C for 40 seconds. This process resulted in loss of memory of the plates. After 4 weeks, there was a change of the bending angle of less than 2.5 degrees.

[Mechanical strength and chemical stability of biodegradable block-polymerized and injection molded poly-L-lactide in vitro]. / Mechanische Festigkeit und chemische Stabilität von biodegradablem blockpolymerisiertem und spritzgegossenem Poly-L-Lactid in vitro.

Biodegradable poly-L-lactic acid rods made of block-polymerized material (BP; molecular weight 550,000) and injection-moulded rods with high (SGI; molecular weight 121,000) and low (SGA, molecular weight 118,000) molecular orientation were compared 2, 4 and 6 weeks after incubation in enzyme solutions with high hydrolytic activity (esterase, alpha chymotrypsin and peptidase) and in buffer solution (TRIS buffer). The molecular weight, modulus of elasticity, bending strength (three-point bending test), and cyclic bending load to failure applied to the rods in a newly developed testing machine (1 Hz, maximum 100,000 cycles) were compared. The molecular weight of BP material decreased to 36% after 2 weeks, in contrast to the injection-moulded materials, in which it decreased only to 66% even after 6 weeks. The bending strength of all specimen decreased significantly faster in alpha chymotrypsin than in the other media (MANOVA, P < 0.001). SGI had a significantly higher bending strength than SGA, and SGA a higher strength than BP. There was no difference after incubation in the other two enzymatic solutions. BP lost 80% of its initial bending strength (140 N/mm2) after 6 weeks, and SGI and SGA (120 N/mm2) only 20%. Under permanent cyclic loading BP initially resisted 100,000 cycles with an applied cyclic load of 12.5 N/mm2, decreasing after 6 weeks to only 9,500 cycles, in contrast to SGI and SGA, which resisted to 46,000 cycles. There was, however, no relevant difference in the mechanical characteristics of the two injection-moulded rods. These results confirm that BP is degraded significantly faster than SGA and SGI.(ABSTRACT TRUNCATED AT 250 WORDS)

Experimental studies of DL-polylactic acid biodegradable plates and screws in rabbits: computed tomography and molecular weight loss.

A series of studies were designed to assess the potential of biodegradable DL-polylactic acid (DL-PLA) plates and screws for use in craniofacial surgery. We report on computed tomography (CT) scanning for visualization and postoperative follow-up and the short-term degradation sequelae of a biodegradable plate and screw system in an experimental animal model. Fractures of the nasal bones were created in 20 adult New Zealand white rabbits and rigidly fixed bilaterally with 4-hole plates and screws (n = 12), or left unrepaired for control data (n = 8). CT density, molecular weight, loss of plates and screws, and preliminary bone healing were assessed at 1, 2, 4, and 6 weeks postoperatively. Histologically, no differences in bone healing were noted between control and experimental animals at any time. Three-dimensional CT reconstruction of the skull was possible without artifacts, and no significant differences (p > 0.05) were found in specific CT scan density levels across postoperative intervals. However, significant (p < 0.001) molecular weight loss of the biodegradable plates was observed through 6 weeks postoperatively, reaching approximately 50% of the preoperative molecular weight. Molecular weight loss, however, was not detectable with CT density measurements. Results demonstrated that the use of biodegradable DL-PLA plates and screws had no adverse effect on fracture healing in this model and that CT scanning and three-dimensional reconstruction were possible without artifacts, independent of material degradation and molecular weight loss. These results suggest that this DL-PLA biodegradable system may have the potential for use in craniomandibulofacial surgery when short-term rigid fixation is necessary.

Injection moulding of biodegradable implants.

In medical engineering, degradable polymers represent an attractive alternative for conventional materials to be used as implants in the body. They are used as drug deliveries or as plates and screws to fix broken bones. Since they are completely broken down by the human body, the second operation, which is generally required, can be avoided. A central problem is the processing of these polymers, because no stabilisers are allowed. This causes a partially relevant loss in molecular weight, which correlates directly with the mechanical properties. Tests carried out on an injection moulding machine and on a conical plate rheometer show the influence of temperature, shear, residence time and moisture on molecular weight reduction and mechanical properties.