Matthijs R. Krijnen

Radiographic, histologic, and chemical evaluation of bioresorbable 70/30 poly-L-lactide-CO-D, L-lactide interbody fusion cages in a goat model.

Study Design. A study of lumbar interbody fusion using polylactic acid-based bioresorbable fusion cages in a goat model. Objective. To evaluate the effect of polylactic acid polymer composition, and internal stabilization on the rate and quality of interbody fusion. Summary of Background Data. A spinal cage should provide an appropriate biomechanical environment to facilitate interbody fusion. Previous studies have shown that bioresorbable polylactic acid-based cages can provide adequate stability for spinal fusion. However, at present and to our knowledge, the best bioresorbable materials, optimal cage stiffness, and desired period over which the cage should biodegrade are unknown. Methods. Interbody fusions were performed at L3–L4 level in 35 skeletally mature Dutch milk goats. Titanium and poly-L-lactide-CO-D,L-lactide (PLDLLA) cages were implanted at random as stand-alone cages. In addition, PLDLLA cages were implanted with anterior fixation. The goats were euthanized at 3, 6, or 12 months. Radiographic, magnetic resonance imaging, histologic, and histomorphometric analyses were performed on retrieved segments. Chemical analysis was used to assess degradation of the retrieved PLDLLA cages. Beforehand, chemical and mechanical degradation of the PLDLLA cages were assessed in vitro. Results. At 3 months, bone graft was almost completely remodeled. Endochondral bone formation was observed in all specimens. At 6 months, 50% of the PLDLLA stand-alone cages and 83% of the PLDLLA anterior fixation cages were fused. At 12 months, 38% of the PLDLLA stand-alone and 83% of the titanium cages realized fusion. A very mild and dispersed foreign body reaction was seen in all PLDLLA specimens. E-beam sterilized PLDLLA cages degraded more rapidly in vivo as compared to both, PLDLLA cages in vitro, and ethylene oxide sterilized poly-L-lactic acid cages in vivo. Conclusions. Within the 3—6-month period, PLDLLA stand-alone cages provided insufficient mechanical stability, which manifested as cracking and deformation of the cages and lower fusion rates. This result implies that within this time, additional stabilization is required; supplemental internal fixation proved sufficient to obtain successful fusion. In all cases, only a mild host response was seen, indicating good biocompatibility.

Primary spinal segment stability with a stand-alone cage: In vitro evaluation of a successful goat model

Background Interbody cages have been developed to restore disk height and to increase stability of the spinal segment, and thereby enhance fusion. However, they often prove inadequate as a stand-alone device. It is unknown how much primary stability is required to facilitate fusion. In various goat studies, we have obtained spinal fusion routinely with a stand-alone cage device. However, data covering the mechanical conditions under which these fusions have been obtained are lacking. In this study, we addressed the issue of primary stability. Methods We used an established goat model for spinal fusion in vitro. 48 native lumbar spine segments were mechanically tested in flexion/extension, axial torsion (left/right), anterior/posterior shear, and left/right lateral bending. Then all segments were provided with a titanium cage using the exact surgical procedure of our earlier in vivo studies, and the mechanical tests were repeated. Under shear force and axial torsion, a significant loss of stiffness was seen in the operated segments as compared to nonoperated controls. No increase in stiffness was found in any of the loading directions. Interpretation Cage implantation in a lumbar spinal segment does not increase immediate postoperative stability as compared to the native segment in this goat model. This is attributable to both the annular damage during cage implantation and the subsequent loss of segment height. Yet previous in vivo studies using this goat model have generally shown fusion. This implies that high primary segment stability is not required for fusion or, alternatively, that the tested range of motion of the spinal segment in vitro does not occur at these magnitudes in vivo.

Does bioresorbable cage material influence segment stability in spinal interbody fusion

To reduce long term complications associated with nonresorbable interbody fusion cages, bioresorbable cages are being developed. We investigated the influence of bioresorbable cage material on segment stability, intervertebral disc height and fusion in vivo using radiostereometric analysis comparing 70/30 poly(L-lactide-co-D,L-lactide) (PLDLLA) cages with titanium cages. Twenty-eight goats were randomized to receive PLDLLA (n = 21) or a titanium control (n = 7) cage at L3-L4. Range of motion for flexion and extension and change in intervertebral disc height were measured before and after surgery and at followup (3, 6, and 12 months). Fusion was graded with a validated radiographic score. Although the PLDLLA cage could not provide the optimal environment for a successful high fusion rate, the range of motion of the PLDLLA segments gradually decreased in time and was similar to the titanium control group at 12 months. In addition the decrease of intervertebral disc height was similar for both PLDLLA (1.4 ± 0.8 mm) and titanium (1.3 ± 1.0 mm) specimens. Both results showed a bioresorbable cage does not lead to less decrease of motion or more loss of intervertebral disc height in time compared to titanium. This study therefore supports further development of a bioresorbable cage concept.