Dual pitch titanium-coated pedicle screws improve initial and early fixation in a polyetheretherketone rod semi-rigid fixation system in sheep

BACKGROUND: Reports on the efficacy of modifications to the thread design of pedicle screws are scarce. The aim of the study was to investigate initial and early fixation of pedicle screws with a plasma-sprayed titanium coating and dual pitch in the pedicle region (dual pitch titanium-coated pedicle screw [DPTCPS]) in a polyetheretherketone (PEEK) rod semi-rigid fixation system. METHODS: Fifty-four sheep spine specimens and 64 sheep were used to investigate initial (“0-week” controls) and early (post-operative 6 months) fixation, respectively. Sheep were divided into dual pitch pedicle screw (DPPS), standard pitch pedicle screw (SPPS), DPTCPS, and standard pitch titanium-coated pedicle screw (SPTCPS) groups. Specimens/sheep were instrumented with four screws and two rods. Biomechanical evaluations were performed, and histology at the implant-bone interface was investigated. RESULTS: At 0-week, mean axial pull-out strength was significantly higher for the DPTCPS and SPTCPS than the SPPS (557.0 ± 25.2 vs. 459.1 ± 19.1 N, t = 3.61, P < 0.05; 622.6 ± 25.2 vs. 459.1 ± 19.1 N, t = 3.43, P < 0.05). On toggle-testing, the DPTCPS was significantly more resistant than the SPPS and SPTCPS (343.4 ± 16.5 vs. 237.5 ± 12.9 N, t = 3.52, P < 0.05; 343.4 ± 16.5 vs. 289.9 ± 12.8 N, t = 3.12, P < 0.05; 124.7 ± 13.5 vs. 41.9 ± 4.3 cycles, t = 2.18, P < 0.05; 124.7 ± 13.5 vs.79.5 ± 11.8 cycles, t = 2.76, P < 0.05). On cyclic loading, maximum displacement was significantly lower for the DPTCPS than the SPPS and SPTCPS (1.8 ± 0.13 vs. 3.76 ± 0.19 mm, t = 2.29, P < 0.05; 1.8 ± 0.13 vs. 2.46 ± 10.20 mm, t = 2.69, P < 0.05). At post-operative 6 months, mean axial pull-out strength was significantly higher for the DPTCPS and SPTCPS than the SPPS (908.4 ± 33.6 vs. 646.5 ± 59.4 N, t = 3.34, P < 0.05; 925.9 ± 53.9 vs. 646.5 ± 59.4 N, t = 3.37, P < 0.05). On toggle-testing, the DPTCPS was significantly more resistant than the SPPS and SPTCPS (496.9 ± 17.9 vs. 370.3 ± 16.4 N, t = 2.86, P < 0.05; 496.9 ± 17.9 vs. 414.1 ± 12.8 N, t = 2.74, P < 0.05; 249.1 ± 11.0 vs.149.9 ± 11.1 cycles, t = 2.54, P < 0.05; 249.1 ± 11.0 vs.199.8 ± 7.2 cycles, t = 2.61, P < 0.05). On cyclic loading, maximum displacement was significantly lower for the DPTCPS than the SPPS and SPTCPS (0.96 ± 0.11 vs. 2.39 ± 0.14 mm, t = 2.57, P < 0.05; 0.96 ± 0.11 vs. 1.82 ± 0.12 mm, t = 2.73, P < 0.05). Resistance to toggle testing (370.3 ± 16.4 vs. 414.1 ± 12.8 N, t = 3.29, P < 0.05; 149.9 ± 11.1 vs.199.8 ± 7.2 cycles, t = 2.97, P < 0.05) was significantly lower and maximum displacement in cyclic loading (2.39 ± 0.14 vs.1.82 ± 0.12 mm; t = 3.06, P < 0.05) was significantly higher for the SPTCPS than the DPTCPS. Bone-to-implant contact was significantly increased for the DPTCPS compared to the SPPS (58.3% ± 7.0% vs. 36.5% ± 4.4%, t = 2.74, P < 0.05); there was no inflammatory reaction or degradation of coated particles. CONCLUSION: DPTCPSs might have stronger initial and early fixation in a PEEK rod semi-rigid fixation system.