Abstract
The osteointegration of a new three-dimensional reticular titanium material, Trabecular Titanium™, was assessed using a bilateral cancellous (distal femur, proximal tibia) and cortical (tibia diaphysis) bone drill hole model in 18 sheep. TT is a novel Ti6Al4V material characterized by a high open porosity and composed of multi-planar regular hexagonal cells. Two 5.0 mm diameter, 12 mm long cylinders (TT1 & TT2) of two different porosities (TT1:650 μm, TT2:1250 μm) were tested and compared to two solid predicate 5.0 mm diameter, 12 mm long Ti cylinders (PT1 & PT2) coated with porous Ti (PT1: vacuum-plasma spray coating; PT2: inert-gas shielding arc spray coating).
Each implant type was surgically implanted at 4 separate locations in each sheep (16 implants per sheep). Three timepoints of 4, 16 and 52 weeks (n=6 sheep per timepoint) were used. Bone-implant interface was analyzed ex vivo by the determination of: 1) the shear strength (SS) measured during a push out test, 2) the percentage of bone in-growth (%B) using histomorphometry, 3) the bone apposition rate using fluorochrome labelling analysis and 4) the bone-implant contact using backscattered scanning electron microscopy (SEM). An ANOVA with a Bonferroni Post hoc test were used to detect differences between tested and predicate implants. P values 0.05 were considered significant.
At 4 weeks, 5 out of the 6 TT1 could be pushed out of the cortical bone (COB) samples. The remaining TT1 collapsed during testing. All TT1 could be pushed of the cancellous bone (CAB) samples. Four out of the 6 TT2 could be pushed out of CAB and of the COB samples. At 16 and 52 weeks, only one TT1 and one TT2 could be pushed out of the bone samples, the remaining implants collapsed during testing. All the PTs were successfully pushed out at all timepoints.
The mean %B of PT1 and PT2 did not significantly increase over time. For both materials, the mean %B ranged between 1.7% and 4.4% at 4 weeks and between 5.7% and 6.5% at 52 weeks. The mean %B of TT1 significantly increased over time in both COB (10.2% at 4 weeks, 46.2% at 16 weeks, 50.5% at 52 weeks) and CAB (5.8%, 23.9%, 24.3%). Similarly, the mean %B of TT2 significantly increased over time in both COB (7.8%, 48.6%, 65%) and CAB (4.5%, 24.1%, 38.6%). Bone apposition rates for the TT implants remained superior to 2 μm/day for the entire duration of the study. SEM showed an intimate bone-implant contact for all implant types at all timepoints.
At 16 and 52 weeks, histomorphometry revealed an extensive osteointegration of the TT specimens. Bone-implant interface strength was so high for the TT implants that they could not be pushed out of the bone samples. The results of this study would indicate that the TT implants provide a good scaffold for bone in-growth.
