New cage for posterior minimally invasive lumbar interbody fusion: a study in vitro and in vivo.

Objective: To design a new type of interbody fusion device made of nickel titanium NiTi shape memory alloy and to compare segmental stiffness after various posterior lumbar interbody fusion (PLIF) procedures in vitro and in vivo.

Methods: Twelve sheep lumbar functional spinal units were randomly allocated to four groups. One acted as controls (N); the other three were treated with autogenous iliac crest bone dowel graft (L), a threaded cylindrical titanium (KC) interbody fusion device (TFC) or a new type of interbody fusion device made of NiTi shape memory alloy (NT) containing autogenous iliac crest graft. In addition, 15 sheep were allocated to three groups; one served as controls and the other two underwent TFC (KC) or NiTi-FC (NT). Nondestructive mechanical tests were performed in pure compression, extension, lateral bending and torsion. The operated spines were photographed regularly to assess changes in interbody height and degree of fusion. The animals were killed at 6 months for histologic testing.

Results: Biomechanical tests showed both the strength and axial stiffness of the NT and KC groups were significantly higher than those of the control group and L group (P < 0.05). When the mechanical performance in torque and torsion of each group were compared, the same results could be obtained. The maximal destructive load of the NiTi-TFC was 11 200 N and the safety coefficient was above 1.2. Radiological observations revealed that the bone callus around the interbody fusion device were gradually increased postoperatively (2 months, no obvious; 4 months, poorly define; 6 months, dense). The KC and NT group had lost 16% and 16.5% of their postoperative height but remained well above normal disc height (P < 0.05). Histologic examination showed new trabeculation connected with that of the host.

Conclusion: The mechanical characteristics of the NiTi-TFC are excellent and it is safe and reliable.