Injectable bone cement cannulated pedicle screw for lumbar degenerative disease in osteoporosis - clinical follow-up of over 5 years.

OBJECTIVE: The aim of this study is to evaluate the clinical efficacy of injectable cemented hollow pedicle screw (CICPS) in the treatment of osteoporotic lumbar degenerative diseases through a large sample long-term follow-up study. Additionally, we aim to explore the risk factors affecting interbody fusion. METHODS: A total of 98 patients who underwent CICPS for transforaminal lumbar interbody fusion (TLIF) for osteoporotic lumbar degenerative disease from March 2011 to September 2017 were analyzed. X-ray and electronic computed tomography (CT) imaging data were collected during preoperative, postoperative, and follow-up periods. The data included changes in intervertebral space height (ΔH), screw failure, cement leakage (CL), and intervertebral fusion. The patients were divided into two groups based on their fusion status one year after surgery: satisfied group A and dissatisfied group B. Surgical data such as operation time, intraoperative bleeding volume and surgical complications were recorded, and visual analog scale (VAS) and Oswestry disability index (ODI) were used to evaluate the improvement of lumbar and leg pain. RESULTS: The mean follow-up time was 101.29 months (ranging from 70 to 128 months). A total of 320 CICPS were used, with 26 screws (8.13%) leaking, 3 screws (0.94%) experiencing cement augmentation failure, and 1 screw (0.31%) becoming loose and breaking. The remaining screws were not loose or pulled out. Female gender, decreased bone density, and CL were identified as risk factors affecting interbody fusion (P < 0.05). Early realization of interbody fusion can effectively prevent the loss of intervertebral space height (P < 0.05) and maintain the surgical treatment effect. Both VAS and ODI scores showed significant improvement during the follow-up period (P < 0.05). Binary logistic regression analysis revealed that decreased bone density and cement leakage were risk factors for prolonged interbody fusion. CONCLUSIONS: The results of long-term follow-up indicate that PMMA enhanced CICPS has unique advantages in achieving good clinical efficacy in the treatment of osteoporosis lumbar degenerative diseases. Attention should be paid to identify female gender, severe osteoporosis, and CL as risk factors affecting interbody fusion.

Second-generation bone cement-injectable cannulated pedicle screws for osteoporosis: biomechanical and finite element analyses.

BACKGROUND: Biomechanical and finite element analyses were performed to investigate the efficacy of second-generation bone cement-injectable cannulated pedicle screws (CICPS) in osteoporosis. METHODS: This study used the biomechanical test module of polyurethane to simulate osteoporotic cancellous bone. Polymethylmethacrylate (PMMA) bone cement was used to anchor the pedicle screws in the module. The specimens were divided into two groups for the mechanical tests: the experimental group (second-generation CICPS) and control group (first-generation CICPS). Safety was evaluated using maximum shear force, static bending, and dynamic bending tests. Biomechanical stability evaluations included the maximum axial pullout force and rotary torque tests. X-ray imaging and computed tomography were used to evaluate the distribution of bone cement 24 h after PMMA injection, and stress distribution at the screw fracture and screw-cement-bone interface was assessed using finite element analysis. RESULTS: Mechanical testing revealed that the experimental group (349.8 ± 28.6 N) had a higher maximum axial pullout force than the control group (277.3 ± 8.6 N; P < 0.05). The bending moments of the experimental group (128.5 ± 9.08 N) were comparable to those of the control group (113.4 ± 20.9 N; P > 0.05). The screw-in and spin-out torques of the experimental group were higher than those of the control group (spin-in, 0.793 ± 0.015 vs. 0.577 ± 0.062 N, P < 0.01; spin-out, 0.764 ± 0.027 vs. 0.612 ± 0.049 N, P < 0.01). Bone cement was mainly distributed at the front three-fifths of the screw in both groups, but the distribution was more uniform in the experimental group than in the control group. After pullout, the bone cement was closely connected to the screw, without loosening or fragmentation. In the finite element analysis, stress on the second-generation CICPS was concentrated at the proximal screw outlet, whereas stress on the first-generation CICPS was concentrated at the screw neck, and the screw-bone cement-bone interface stress of the experimental group was smaller than that of the control group. CONCLUSION: These findings suggest that second-generation CICPS have higher safety and stability than first-generation CICPS and may be a superior choice for the treatment of osteoporosis.

Clinical evaluation of the efficacy of a new bone cement-injectable cannulated pedicle screw in the treatment of spondylolysis-type lumbar spondylolisthesis with osteoporosis: a retrospective study.

PURPOSE: To investigate the clinical efficacy and safety of a bone cement-injectable cannulated pedicle screw (CICPS) in the treatment of spondylolysis-type lumbar spondylolisthesis with osteoporosis. METHODS: A retrospective study was conducted on 37 patients (Dual-energy X-ray bone density detection showed different degrees of osteoporosis) with spondylolysis-type lumbar spondylolisthesis who underwent lumbar spondylolisthesis reduction and fusion using a new type of injectable bone cement screw from May 2011 to March 2015. Postoperative clinical efficacy was evaluated by the Visual Analogue Scale (VAS) scores and the Oswestry Disability Index (ODI). Imaging indexes were used to evaluate the stability of internal fixation of the devices 1, 3, 6, and 12 months after surgery and annually thereafter. The safety of the CICPS was assessed by the prevalence of intraoperative and postoperative complications. RESULTS: A total of 124 CICPS were implanted intraoperatively. Bone cement leakage occurred in 3 screws (2.42%), and no clinical discomfort was found in any patients. All 37 patients were followed up with an average follow-up time of 26.6 ± 13.4 months (12-58 months). In the evaluation of the clinical effects of the operation, the average postoperative VAS score of the patients decreased from 4.30 ± 1.58 before surgery to 0.30 ± 0.70 after surgery (P < 0.001), and the ODI decreased from 47.27% ± 16.97% before surgery to 3.36% ± 5.70% after surgery (P < 0.001). No screw was loose, broken or pulled out. CONCLUSION: CICPS is safe and effective in the treatment of spondylolysis-type lumbar spondylolisthesis complicated by osteoporosis.

Demineralized bone matrix combined with cytotoxic T-lymphocyte-associated protein 4 promotes osteogenic differentiation of human bone marrow mesenchymal stem cells and suppresses the activation of T lymphocytes in vitro.

Cytotoxic T-lymphocyte-associated protein 4 (CTLA4) can promote osteogenic differentiation of human bone marrow mesenchymal stem cells (hBMMSCs), and CTLA4-modified bone marrow mesenchymal stem cells possess immunoregulatory effects. In the present study, we aimed to construct a new tissue engineering bone using demineralized bone matrix and CTLA4 protein, designated as DBM-CTLA4 (+). The effects of DBM-CTLA4 (+) on the osteogenic differentiation of hBMMSCs and T lymphocyte activation were evaluated through in vitro experiments. The cumulative release of CTLA4 from DBM-CTLA4 (+) was determined using enzyme-linked immunosorbent assay. DBM-CTLA4 (+) was co-cultured in a Transwell chamber with either phytohemagglutinin-treated hBMMSCs or human peripheral blood mononuclear cells (hPBMCs). Osteogenic differentiation of hBMMSCs was assessed by calcium deposition, ALP activity, and the protein levels of COL1A1, RUNX2, BMP2, and OPN. T lymphocyte activity was assessed by measuring the protein levels of IL-2, L-17, HLA-DRA1, IFN-γ, and RANKL. Our results showed that the cumulative release rates of CTLA4 at 7, 14, 21, and 28 days were 12.6% ± 1.4%, 30.2% ± 2.3%, 49.8% ± 3.8%, and 60.5% ± 2.7%, respectively. Compared to the negative control, DBM-CTLA4 (+) promoted the proliferation of hBMMSCs, and enhanced calcium deposition, ALP activity, and protein levels of COL1A1, RUNX2, BMP2, and OPN. Moreover, DBM-CTLA4 (+) decreased the levels of IL-2, IL-17, HLA-DR, IFN-γ, and RANKL in hPBMCs treated with phytohemagglutinin. In conclusion, DBM-CTLA4 (+) promoted proliferation and osteogenic differentiation of hBMMSCs and suppressed T lymphocyte activation.