Evaluation of bioabsorbable multiamino acid copolymer/α-tri-calcium phosphate interbody fusion cages in a goat model.

STUDY DESIGN: A study of cervical interbody fusion using polyamino acid-based bioabsorbable fusion cages in a goat model.

OBJECTIVE: To compare interbody fusion of a bioabsorbable multiamino acid copolymer/α-tri-calcium phosphate (MAACP/α-TCP) fusion cage with an autologous tricortical iliac-crest bone graft and a titanium cage.

SUMMARY OF BACKGROUND DATA: Polyamino acid is widely used as a carrier for drug delivery. To our knowledge, no study investigates interbody fusion cage made of polyamino acid.

METHODS: A total of 15 sheep underwent C3/C4 discectomy and fusion. The following stabilization techniques were used: group A, autologous tricortical iliac crest bone graft (n = 5); group B, MAACP/α-TCP cage filled with autologous cancellous bone graft (n = 5); group C, titanium cage filled with autologous cancellous bone graft (n = 5). Radiographic scans to determine disc space height were performed before and after surgery and after 4, 8, and 12 weeks, respectively. After 12 weeks, the C3/C4 motion segment was isolated and sectioned to create a 5-mm thick parasagittal section from which lateral radiographs were obtained. All the radiographs were encoded and reviewed in a blinded fashion to evaluate interbody fusion within the cage devices according to a three-point radiographic score. Biomechanical testing was performed in flexion, extension, axial rotation, and lateral bending to determine range of motion (ROM). Histomorphological and histomorphometrical analyses were performed to evaluate fusion and foreign-body reactions associated with the bioabsorbable cages.

RESULTS: Radiographic results showed that the disc space height (DSH) in MAACP/α-TCP cage group was better than that of bone graft group and the best radiographic score was found in MAACP/α-TCP cage group. Biomechanical test showed that no significant difference was found in ROM between MAACP/α-TCP cage group and titanium cage group whereas the value of ROM in bone graft group was the largest. Histologic evaluation showed a higher intervertebral bone volume/total volume ratio and a better interbody fusion in the MAACP/α-TCP cage group than in the other two groups. Two MAACP/α-TCP cages showed microcracks and the other three cages had maintained their original geometry. All MAACP/α-TCP cages showed excellent biocompatibility.

CONCLUSION: After 12 weeks, there was no significant difference between the MAACP/α-TCP cage and the titanium cage in distractive properties and biomechanical properties. Compared with titanium cages, MAACP/α-TCP cages showed an advanced interbody fusion. Although MAACP/α-TCP cages developed cracks after only 12 weeks, they showed significantly better distractive properties, biomechanical properties, and an advanced interbody fusion than the tricortical iliac crest bone graft. Improvement should be made to insure the strength of MAACP/α-TCP cage last at least 6 month after implantion.