[Experimental study of percutaneous vertebroplasty with a novel bone void filling container system].

OBJECTIVE: To investigate vertebral augmentation with a novel reticulate bone filling container system by polymethyl methacrylate (PMMA) injection in cadaveric simulated vertebral compressive fracture and explore the effect of reticulate bone filling container on cement distribution controlling within vertebral body and the restoration of biomechanical properties after augmentation. METHODS: A total of 28 freshly frozen human vertebrae specimens were randomly divided into 4 groups. After the measurements of bone mineral density (BMD) and vertebral height, each vertebra received an axle load by a MTS (material testing system) machine to test the initial strength and stiffness. Subsequently a simultaneous compressive fracture model was created to measure the stiffness and height of fractured vertebrae. Then the augmentation procedure was performed. Afterward the biomechanical properties and the vertebral height were similarly measured as pre-operatively. The expansion of bone filling container and the distribution of cement within vertebral body were morphologically observed by crossing the specimens in sagittal midline and also integrated with the radiographic results. RESULTS: Stiffness was significantly restored comparing with that of fractured level (P < 0.05). And the bipedicular groups had better restoration results than the unipedicular groups. The strength and height of specimens significantly increased after the augmentation procedure but without difference among groups. In axial radiographic view, the distribution of cement in vertebral body was oval or long oval-shaped in double-layer bone filling container groups while it was irregular in single-layer groups. After crossing, the double-layer version expanded well in vertebral body and could enwrap most of injected cement. There was only a little leakage near the vessel layer. But the single-layer version had a poor expansion and a large amount of cement leakage. CONCLUSION: This novel reticulate bone void filling container system with different layers may restore both the biomechanical properties and the height of fractured vertebrae. But, with the benefit of reducing cement leakage, a double-layer design can enwrap most of injected PMMA and has a brighter prospect of clinical application.

The effect of screw length and bone cement augmentation on the fixation strength of iliac screws: a biomechanical study.

STUDY DESIGN: Comparison of the biomechanical fixation strengths offered by 3 iliac screw fixation techniques: short screw, short screw augmented with cement, and long screw. OBJECTIVE: Evaluate the effect of screw length and bone cement augmentation on the fixation strength of iliac screw upon fatigue loading. SUMMARY OF BACKGROUND DATA: Iliac screws have been used in treating spinal disorders such as spinal deformity, spondylolisthesis, and sacral tumor. In clinical practices, both short screws and long screws are being used. It has been reported that short iliac screws have a higher rate of loosening. Therefore, short iliac screws are being used with bone cement augmentation to improve fixation. To date, no biomechanical study has compared the strengths of these 3 different iliac screw fixation techniques. METHOD: Fresh, frozen human cadaveric pelvis specimens (n = 18, 12 males, 6 females, average age 61 y) were used. Bone density was measured to characterize bone quality. The specimens were randomly divided into 2 groups. In group 1 (n = 8), short screws of 7.0-mm diameter and 70 + or - 4 mm length (as the length of exceeding over ischial notch) and long screw of 7.0-mm diameter and 120 + or - 4 mm length were placed on either side of the pelvis (left and right). In group 2 (n = 10), short iliac screws were placed after augmentation with polymethyl methacrylate bone cement on 1 side of the pelvis and long iliac screw were placed on the other side (left and right). Cyclic loading ranging from 20 to 200 N was applied to each screw at a frequency of 2 Hz up to 5000 cycles. Pullout tests were then conducted at the rate of 5 mm/min after the fatigue test, and the maximum pullout strength for each screw was recorded and analyzed. RESULTS: The maximum pullout strength of the long screw and short screw groups after fatigue conditioning were 2386 + or - 1470 and 833 + or - 681 N respectively. Significant difference was found between the 2 groups (P < 0.05). The short iliac screw had a higher loosening rate. The pullout force of the short screw fixation with augmentation and the long screw fixation after cyclic loading were 2436 + or - 915 and 2529 + or - 1055 N, respectively. No significant difference was found between the 2 groups (P > 0.05). CONCLUSIONS: Short iliac screws are susceptible to loosening after cyclic loading. Bone cement augmentation of short screws has demonstrated a significant increase in the fixation strength of short screws to an extent similar to that of long iliac screws. Thus, short iliac screw fixation after augmentation with bone cement will be a viable clinical option for spino-pelvic reconstruction.

[Experimental study on spinal fusion induced by hBMP-4 gene modified tissue engineered bone].

OBJECTIVE: To evaluate the efficacy of hBMP-4 gene modified tissue engineered bone graft in the enhancement of rabbit spinal fusion and find an ideal kind of substitute for the autograft bone. METHODS: Rabbit BMSCs were cultured and transfected with AAV-hBMP-4 using different MOI value. The optimal MOI value were determined by observing cell's morphology change. BMSCs were then transfected with AAV-hBMP4 and AAV-EGFP respectively, following which the transfected cells were evenly suspended in a collagen sponge I, and implanted to either side of the L5,6 intertransverse spaces posterolateral in the New Zealand rabbits to induce spinal fusion. Fourteen rabbits were randomly divided into 2 groups. Group 1: AAV-hBMP-4 transfected BMSCs in the right side (hBMP-4 side) and autograft bone in the left side. Group 2: AAV-hBMP-4 transfected BMSCs in the right side (hBMP-4 side) and AAV-EGFP transfected BMSCs in the left side (EGFP side). Radiographs and three-dimensional CT of the spine, manual palpation, gross and histological examination of the fusion masses for all the animals were performed subsequent to animals having been sacrificed at 12 weeks after surgery. RESULTS: Evaluation has been taken in 12 New Zealand rabbits delivered into 2 groups which meet the criterion after operation. Eleven in 12 implemented sides involved hBMP-4 achieved bony fusion, to which 5 in 6 autografted sides was similar. But only 2 in 6 sides in EGFP-group achieved bony fusion meanwhile. Three-dimensional CT scan and palpation also evidenced the results. Bone formation was observed obviously on specimen both in hBMP4 sides and autografted ones. EGFP-group also got bony integration, but the quantity was small. CONCLUSION: Tissue-engineered bone graft constructed from application of hBMP4 is a fine substitute for autograft. Effective enhancement of bony integration in spinal fusion surgery has been evidenced in vivo.

Preliminary clinical outcomes of percutaneous kyphoplasty with Sky-bone expander.

BACKGROUND: Percutaneous kyphoplasty (PKP) using balloon expander has been proved to be effective in the treatment of painful vertebral compression fractures. Recently, Sky-bone expander, an alternative bone expander for PKP has been developed. The purpose of this study was to show our preliminary clinical outcomes of PKP with Sky-bone expander. METHODS: PKP with Sky-bone expander was performed in 25 patients (30 vertebrae). The operation time, bleeding volume, cement volume injected were recorded. The pain and functional activities of the patients before and after the operation were compared using Wilcoxon signed-rank test. The cement distribution in the vertebrae, vertebral height restoration, and kyphosis correction after the procedure were evaluated by radiography. The pre- and post-operative absolute values of the vertebral height and kyphotic angle were compared by paired-sample t test. All the patients were followed up by telephone or clinic consulting after being discharged from our hospital. RESULTS: The procedure was performed successfully in all the patients. Bipedicular injection was used in 2 of the patients, and unipedicular injection was made in the others. The operation time ranged from 25 to 120 minutes (45 minutes per vertebra on average). The average bleeding volume was about 20 ml. Polymethylmethacrylate 1.5-5.0 ml (mean, (3.15+/-0.78) ml) was injected through each pedicle into all the patients except one, who received calcium sulphate 3.5 ml instead. The patients were followed up for 12-15 months (13.5 months on average). The mean visual analogue scale (VAS) score, Oswestry Disability Index, anterior, midline, and posterior vertebral height, and kyphotic angle of the patients were improved significantly at the end of the follow-up compared with those before the operation. (2.5+/-1.3, 35.1%, (20.94+/-6.15) mm, (20.26+/-4.59) mm, (26.72+/-3.49) mm, and 8.2 degrees vs. 8.5+/-1.9, 61.2%, (19.11+/-6.72) mm, (15.88+/-5.73) mm, (25.78+/-3.67) mm, and 17.3 degrees; all P<0.05). The cement distribution with unipedicular injection was mostly limited within the injection site in the vertebral body. Cement extravasation was seen at ten levels (33.3%). CONCLUSIONS: PKP with Sky-bone expander is an effective and relatively safe alternative to the PKP using balloon expander. It can relieve pain, improve physical function, and restore the height of the collapsed vertebrae, but the cement extravasation is unsolved.

[Percutaneous vertebroplasty with EH composite material: an experiment study].

OBJECTIVE: To investigate the appropriate ratio of liquid/powder and use of radiopaque agent in EH composite material for percutaneous vertebroplasty (PVP). METHODS: (1) EH composite material was divided into 6 groups. The material without contrast with the liquid/powder ratios 8:9, 8:8, and 8:7 was classifieds as groups I, II, and III; and the EH composite material with the liquid/powder ratios 8:9, 8:8, and 8:7 and with the addition of 20% barium sulfate by weight was classified as the groups IV, V, and VI. The curing temperature was measured. The bone cement of different groups was made into cylinders to be X-rayed to observe the opacity. Universal tester was used to examine the strength and stiffness. (2) The vertebrae (T8 approximately L5) were isolated from the cadaver of an elder female patient with osteoporosis. Universal tester was used to examine the strength and stiffness of the vertebral bodies (VBs). Osteoporotic vertebral compression fracture (OVCF) model was made. PVP procedure was mimicked by puncturing through the bilateral pedicle of vertebral arch into the anterior 1/3 of the vertebral bodies and the EH composite materials of the groups II and V were injected into the VBs Then the temperatures of the geometric center (CT) and spinal canal posterior wall (PT) of the VBs were measured in a water bath with the temperature of 37 degrees C. Twenty-four hours later the vertebrae underwent X-ray examination to observe the opacity and underwent examination of strength and stiffness with universal tester. RESULTS: (1) The sticking periods (?) of the groups IV, V, and VI were significantly longer than those of the corresponding groups I, II, and III respectively by about 60 s, and the highest temperature of the groups IV, V, and VI were significantly lower than those of the corresponding groups I, II, and III respectively. Addition1 of barium sulfate increased the opacity of the bone cement, but did nor significantly influence the strength of the bone cement. The properties of the group V was the best. (2) The bone cement was easy to be injected into the VBs. The peak PT was not beyond 50 degrees C. After the injection of the bone cement of the groups II, the strength and stiffness of the VB were (1501.6 +/- 5.0) N/mm and (285.6 +/-) N/mm, both significantly higher than those before the injection [(547.5 +/- 3.1) N/mm and (104.1 +/- 1.3) N/mm]; and after the injection of the bone cement of the groups V, the strength and stiffness of the VB were (1355.0 +/- 4.5) N/mm and (257.7 +/- 1.9), both significantly higher than those before the injection [(543.8 +/- 2.7) N/mm and (103.4 +/- 1.1) N/mm]. The opacity of the VBs injected with the bone cement of the group V was better than those injected with the bone cement of the group II. CONCLUSION: The EH (8/8) with 20% barium sulfate is a proper and effective filling material for the treatment of OVCF.

Biomechanical effects of insertion location and bone cement augmentation on the anchoring strength of iliac screw.

BACKGROUND: Iliac screw loosening has been a clinical problem in the lumbo-pelvic reconstruction. Although iliac screws are commonly inserted into either upper or lower iliac column, the biomechanical effects of the two fixations and their revision techniques with bone cement remain undetermined. The purpose of this study was to compare the anchoring strengths of the upper and lower iliac screws with and without cement augmentation. METHODS: 5 pairs of formalin fixed cadaveric ilia with the bone mineral density values ranged from 0.82 to 0.97 g/cm(2) were adopted in this study. Using screws with 70-mm length and 7.5-mm diameter, 2 conventional iliac screw fixations and their revision techniques with cement augmentation were sequentially established and tested on the same ilium as follows: upper screw, upper cement screw, lower screw, and lower cement screw. Following 2000 cyclic compressive loading of -300 N to -100 N to the screw on a material testing machine, the maximum pull-out strengths were measured and analyzed. FINDINGS: The average pull-out strengths of upper, upper cement, lower, and lower cement screws were 964 N, 1462 N, 1537 N, and 1964 N, respectively. The lower screw showed significantly higher pull-out strength than the upper one (P=0.008). The cement augmentation notably increased the pull-out strengths of both upper and lower screws. The positive correlation between pull-out strength and bone mineral density value was obtained for the 4 fixations. INTERPRETATION: The lower iliac screw technique should be the preferred choice in lumbo-pelvic stabilization surgery; cement augmentation may serve as a useful salvage technique for iliac screw loosening; preoperative evaluation of bone quality is crucial for predicting fixation strength of iliac screw.

Effect of the degree of osteoporosis on the biomechanical anchoring strength of the sacral pedicle screws: an in vitro comparison between unaugmented bicortical screws and polymethylmethacrylate augmented unicortical screws.

STUDY DESIGN: An in vitro laboratory study. OBJECTIVE: (i) To evaluate the effect of osteoporotic degree in determining the strength of sacral screw fixation and (ii) to compare the strength of unaugmented bicortical pedicle screw and polymethylmethacrylate (PMMA) augmented unicortical pedicle screw in sacral fixation. SUMMARY OF BACKGROUND DATA: Screw loosening is a clinical problem in lumbosacral fusions, especially in osteoporotic patients. To improve the screw anchoring strength of sacrum, bicortical and PMMA augmented sacral pedicle screw fixation techniques are widely used in clinical practice. However, the biomechanical strength of the bicortical and PMMA augmented sacral screw fixations remains undetermined in different degrees of osteoporosis. METHODS: Twenty-five fresh osteoporotic cadavers were used in this study. According to the value of lumbar bone mineral density (BMD) assessed by DEXA, specimens were divided into 3 groups: group A (N=9): BMD=0.7 to 0.8 g/cm, group B (N=8): BMD=0.6 to 0.7 g/cm, and group C (N=8): BMD<0.6 g/cm. In each specimen, S1 pedicle screw was inserted bicortically on the left side, and S1 pedicle screw with PMMA augmentation was inserted unicortically on the right side of the sacrum. Following a dynamic cyclic loading from 30 to 250 N on the screw head for 2000 cycles, the subsidence displacement and axial pull-out strength of each screw were measured. RESULTS: No anchoring failure (defined as the subsidence displacement exceeding 2 mm within 2000 loading cycles) occurred in group A and B. However, in group C, 6 cases (75%) in bicortical fixation and 5 cases (63%) in PMMA augmented fixation failed during cyclic loading. In group A, no significant difference between the bicortical and PMMA augmented fixations was detected in terms of the subsidence and maximal pull-out strength. In group B, significantly less subsidence and higher maximal pull-out strength were demonstrated in the PMMA augmented technique than that in the bicortical fixation. Both techniques exhibited lower subsidence of the screw in group A than in group B. The bicortical technique exhibited higher maximum pull-out strength in group A than that in group B. However, statistical difference in terms of PMMA augmentation was not detected between group A and B. CONCLUSION: For BMD value more than 0.70 g/cm, bicortical sacral pedicle screw fixation could obtain sufficient anchoring strength comparable with the PMMA augmented technique. When BMD value is within 0.6 to 0.7 g/cm, the PMMA augmented technique would be more beneficial in improving the fixation strength than the bicortical fixation. For BMD values less than 0.6 g/cm, early screw loosening may occur in both bicortical and PMMA augmented fixations.