Shi-yong Wan

Effect of ovariectomy on BMD, micro-architecture and biomechanics of cortical and cancellous bones in a sheep model.

Osteoporotic/osteopenia fractures occur most frequently in trabeculae-rich skeletal sites. The purpose of this study was to use a high-resolution micro-computed tomography (micro-CT) and dual energy X-ray absorptionmeter (DEXA) to investigate the changes in micro-architecture and bone mineral density (BMD) in a sheep model resulted from ovariectomy (OVX). Biomechanical tests were performed to evaluate the strength of the trabecular bone. Twenty adult sheeps were randomly divided into three groups: sham group (n=8), group 1 (n=4) and group 2 (n=8). In groups 1 and 2, all sheep were ovariectomized (OVX); in the sham group, the ovaries were located and the oviducts were ligated. In all animals, BMD for lumbar spine was obtained during the surgical procedure. BMD at the spine, femoral neck and femoral condyle was determined 6 months (group 1) and 12 months (group 2) post-OVX. Lumbar spines and femora were obtained and underwent BMD scan, micro-CT analysis. Compressive mechanical properties were determined from biopsies of vertebral bodies and femoral condyles. BMD, micro-architectural parameters and mechanical properties of cancellous bone did not decrease significantly at 6 months post-OVX. Twelve months after OVX, BMD, micro-architectural parameters and mechanical properties decreased significantly. The results of linear regression analyses showed that trabecular thickness (Tb.Th) (r=0.945, R2=0.886) and bone volume fraction (BV/TV) (r=0.783, R2=0.586) had strong (R2>0.5) correlation to compression stress. In OVX sheep, changes in the structural parameters of trabecular bone are comparable to the human situation during osteoporosis was induced. The sheep model presented seems to meet the criteria for an osteopenia model for fracture treatment with respect to morphometric and mechanical properties. But the duration of OVX must be longer than 12 months to ensure the animal model can be established successfully.

Accuracy and safety assessment of pedicle screw placement using the rapid prototyping technique in severe congenital scoliosis.

Study Design The application of rapid prototyping (RP) technique for improving accuracy of pedicle screw placement in congenital scoliosis is described in this study. Objective To compare the accuracy and safety of pedicle screw placement in congenital scoliosis using the RP technique versus the conventional fluoroscopy. Summary of Background Data Mal developed vertebral components in congenital scoliosis leads to prolonged operation time and higher rate of screw misplacement. RP technique can enhance preoperative and perioperative planning. No data are available on the accuracy of pedicle screw fixation using the RP technique. Methods Sixty-two consecutive patients with hemivertebra had undergone posterior-only hemivertebra resection. Pedicle screws were implanted either by the conventional intraoperative fluoroscopy technique (C-arm group; n=28) or the RP technique (RP group; n=34). Accuracy of pedicle screw placement was compared by postoperative computed tomographic scan. Results Seventy of 677 inserted screws were found to be misplaced, showing an overall accuracy of 89.7% (90.8% in the thoracic spine and 87.4% in the lumbar spine). In the C-arm group, 86.1% (167 of 194) and 82.0% (82 of 100) of screws were accurately placed in the thoracic and lumbar spine, respectively. While in the RP group, the respective screw placement accuracies were 94.4% (238 of 252) and 91.6% (120 of 131). In the C-arm and the RP groups, 94.8% (279 of 294) and 97.9% (375 of 383) of the screws were within the safety zone, respectively. Compared with the fluoroscopy method, the RP-assisted technique showed a shorter operation time and higher scoliosis correction rate. No neurovascular-related complication was observed with this technique during the study. Conclusion The application of RP technique in congenital scoliosis can reduce the operation time, the risk of screw misplacement and its consequent complications. The use of RP technique in congenital scoliosis is safe and efficacious.

Augmentation of pedicle screw stability with calcium sulfate cement in osteoporotic sheep: biomechanical and screw-bone interfacial evaluation.

Study Design Augmentation of pedicle screws with calcium sulfate cement (CSC) was performed in osteoporotic sheep. Biomechanical tests, micro-computed tomography (CT) analysis, and histological observation were performed. Objective To investigate the long-term biomechanical performance of pedicle screws augmented with CSC in vivo and evaluated the screw-bone interfacial bonding with micro-CT and histological techniques. Summary of Background Data There is little information on the long-term biomechanical performance and screw-bone interfacial bonding of pedicle screws augmented with CSC in osteoporosis in vivo. Methods Twelve months after ovariectomy, bilateral pedicles of lumbar vertebrae (L1 to L5) of 6 female sheep were fixed with pedicle screws. One pedicle of each vertebral body was treated with a screw augmented with CSC (CSC group) and the contralateral pedicle was treated with a screw without any augmentation (control group). Three months later, the sheep were killed and biomechanical tests, micro-CT analysis, and histological observation were conducted on the isolated specimen vertebrae. Results Twelve months after ovariectomy, animal model of osteoporosis was established successfully. Both the axial and vertical stabilities of the pedicle screws in CSC group were significantly enhanced compared with those in the control group (P<0.05). Micro-CT reconstruction and analysis showed that there were more bone trabeculae around the screws in CSC group compared with those in control group (P<0.05), and the bone trabeculae were significantly denser than those in control group (P<0.05). Histological observation showed that CSC was completely degradated and bone trabeculae around the screws in CSC group were more and denser than that in the control group. Bone trabeculae held the screws tightly without any interspaces between screw and bone, which formed strong bonding between bone and screw. Conclusions CSC can significantly improve screw-bone interfacial bonding and strengthen the long-term stability of pedicle screws in osteoporotic sheep. Augmentation with CSC may be a potentially useful method to increase the stability of pedicle screws in patients with osteoporosis.

A new method of partial screw augmentation in sheep vertebrae in vitro: biomechanical and interfacial evaluation.

Study Design Partial screw augmentation was carried out by the injection of polymethylmethacrylate (PMMA) through the novel tap into the bone tissue in sheep vertebrae in vitro. Biomechanical tests and microcomputerized tomography analysis were done. Objective To evaluate the stability of the screw and the interface between the bone and the screw in partial screw augmentation. Summary of Background Data Augmentation of the pedicle screw with PMMA improves screw stability significantly. However, it results in the full envelopment of the screw by PMMA and the formation of a full “screw-PMMA-bone” interface, which may increase the difficulties in screw removal. Therefore, it is urgent to develop a novel method to augment screw fixation, which avoids full wrapping of PMMA around the screw and facilitates screw removal. We designed a novel tap with an inner hollow and the multiple lateral apertures. Methods A total of 78 fresh adult sheep lumbar vertebrae were randomly divided into 3 groups. No screw augmentation was performed in the control group. The pilot hole was filled with PMMA in the full screw augmentation group, whereas PMMA was injected through the tap into the bone tissue in the partial screw augmentation group. Pedicle screws were ultimately inserted into all the holes. Axial pullout tests, cyclic bending tests, and microcomputerized tomography analysis were carried out 24 hours after screw fixation. Results Both partial screw augmentation and full screw augmentation caused significant increase in pedicle screw stability compared with the control group in both the axial pullout tests and the cyclic bending resistance tests. Partial screw augmentation resulted in the formation of a partial “screw-bone” interface and a partial screw-PMMA-bone interface, which seems like 3 anchors or roots extending and fixing in the bone tissue in a cross section of the interface. It was obviously different from the complete screw-PMMA-bone interface with a complete PMMA mantle around the screw in the full screw augmentation group. Conclusions Our proof-of-concept study showed that partial screw augmentation could enhance pedicle screw fixation strength, avoided the full surrounding of the PMMA around the screw, and generated a partial screw-PMMA-bone and a partial screw-bone interface. Partial screw augmentation may be a potential method to augment pedicle screw stability.

Staged-injection procedure to prevent cement leakage during vertebroplasty: an in vitro study.

Study Design. Fibrin sealant (FS) combined with or without growth factor was used to improve the micro-architectural and biomechanical properties of vertebral body in osteoporotic ovine spine. Objective. To analyze the treatment effects of bovine bone morphogenetic protein (bBMP) combined with FS on osteopenic ovine vertebral architecture, bone mineral density, and biomechanics in vivo. Summary of Background Data. Vertebroplasty and kyphoplasty were used to treat spinal osteoporosis. They can increase strength of vertebrae physically. However, each has specific disadvantages. bBMP could rapidly increasing bone formation and suppressing bone resorption, but little is known about its effect on ovariectomized-induced osteoporosis. Methods. Six sheep underwent ovariectomy and were placed on a low-calcium diet. Twelve months later, according to Ladin square design, L4–L6 vertebrae in all sheep were randomly assigned to 3 treatment groups: A (30 mg bBMP/1.5 mL FS), B (30 mg bBMP) and C (1.5 mL FS). All materials were injected into the assigned vertebra transpedicularly. Animals were killed 3 months after injection, and bone mineral density (BMD), biomechanics, and histomorphometry were assessed. Analysis of variance was used to determine effects of bBMP/FS (&agr; = 0.05). Results. The BMD in Group 1 was 17.1% and 14.7% higher than that in Group 2 and Group 3, respectively. The micro-CT reconstruction analysis showed that the density and connectivity of trabecular bone in bBMP/FS treated vertebrae were higher than those in control groups. The mechanical properties (yield stress, ultimate stress, energy absorption, bone modulus) of the vertebrae were also significantly higher. In this study, local bBMP/FS treatment showed a positive trend in improving BMD, histomorphometric parameters, and mechanical strength of osteoporotic vertebra. Slow release of bBMP using FS appeared to be an effective method of protein delivery. Conclusion. The use of bBMP/FS in the treatment of vertebral osteoporosis in an attempt to enhance bone strength merits further study.

A Study of Low Elastic Modulus Expandable Pedicle Screws in Osteoporotic Sheep

Study Design Low elastic modulus expandable pedicle screw (L-EPS) was inserted into osteoporotic sheep. Biomechanical tests, micro-CT analysis and histologic observation were performed. Objective To find out whether the L-EPS can further improve fixation strength compared to the expandable pedicle screws (EPS) in osteoporotic sheep spine. The screw-bone interface is also detected by micro-computed tomography (CT) and histologic techniques. Summary of Background Data There are some studies on EPS in vivo; however, no earlier study has focused on the elastic modulus of EPS, especially in osteoporosis. Methods Twelve months after ovariectomy, bilateral pedicles of lumbar vertebrae (L1 to L5) of 4 female sheep were fixed with EPSs. The L-EPS and EPS were randomly placed into each pedicle and then were expanded. Six months later, the sheep were sacrificed and biomechanical tests, micro-CT analysis, and histologic observation were conducted on the isolated specimen vertebrae. Results Twelve months after ovariectomy, animal model of osteoporosis was established successfully. The axial pull-out strength in L-EPS group was significantly enhanced compared with that in the EPS group (P < 0.05). Micro-CT reconstruction and analysis showed that there was more bone around the L-EPS group compared with those in EPS group (P < 0.05), meanwhile the more homogeneous bone formation distribution around the screws was found in the L-EPS group. Histologic observation showed that newly formed bone extended along the expandable fissures and grew into the center of EPS; meanwhile, the more direct contact and the less fibrous tissue on the screw-bone interface were observed in the L-EPS group. Conclusions The L-EPS can further improve the biomechanical fixation strength of EPS in the osteoporotic sheep. The screw elastic matching with surrounding bone is helpful to distribute stress uniformly, relieve the stress shielding effect, and strengthen the screw-bone interface. Although the experience with the L-EPS is very limited and preliminary, results to date indicate that it is of value in treating patients with osteoporosis and warrants further study.

Staged-Injection Procedure to Prevent Cement Leakage During Vertebroplasty: An In Vitro Study

BACKGROUND Epidural leaks or canal intrusion are often found in vertebroplasty, which can lead to several complications. To the best of our knowledge, this is the first report on using two-stage injection procedure in vertebroplasty to reduce cement leakage rate. MATERIALS AND METHODS Fifty cadaveric vertebrae (L1-L5) were harvested from 10 osteoporotic lumbar spines. The age of the female donors ranged from 60 to 72 y; the bone mineral density (BMD) of the vertebrae ranged from 0.226 to 0.631 g/cm(2). Polymethylmethacrylate (PMMA) was injected into vertebral bodies by either novel two-stage injection (1 mL cement was injected at first stage and another 4 mL cement was injected at second stage after the cement solidified) or standard conventional injection procedure. After injection, all vertebral bodies (VBs) were checked for cement leakage into spinal canal by vision and fluoroscopy. Cement leakage rates were recorded. RESULTS The two-stage injection procedure resulted in a significant decrease in the epidural or canal leakage rate (P = 0.032). In addition, the paravertebral leakage rate was significantly higher in two-stage injection procedure group (48%) than in conventional injection procedure group (16%). However, no significant difference was found for the total cement leakage rate between the two groups. CONCLUSION Compared with conventional procedure, the two-stage injection procedure in vertebroplasty decreased incidence of epidural and canal leaks. The first-stage injecting PMMA can be a barrier to the epidural extravasation of cement during vertebroplasty. Further in vivo and clinical researches are needed to evaluate the new procedure.

Expandable pedicle screw trajectory in cadaveric lumbar vertebra: an evaluation using microcomputed tomography.

Study Design An in-vitro cadaver-based measurement using microcomputed tomography. Objectives To evaluate the safety of removal of expandable pedicle screws (EPSs) in human vertebral bodies after a long (6 mo) insertion time. Summary of Background Data Transpedicular fixation is commonly used for posterior fixation of the spine. Osteoporotic patients are in high risk of internal fixation failure. EPS is an available device for increasing transpedical fixation in the osteoporotic spine. However, it is unclear that how much the diameter of the expanding screw tip increases in the human vertebral body, and no reports have assessed the potential for fracture of the pedicle when the EPS is removed. Therefore, the safety of removal of EPS needs to be evaluated. Methods In this study, 6.50 mm EPSs were inserted into cadaveric lumbar vertebrae. The maximum diameters of expansion, the maximum diameters of the EPS trajectories, and the diameters of the EPS trajectories in the pedicles were measured using microcomputed tomography imaging and 3-dimensional reconstruction. Regions of interest of the same size adjacent to the EPS in the pedicle and in the vertebral body were reconstructed and analyzed using the same thresholds (1000). Bone volume divided by total volume (BV/TV) in these regions of interest was determined. Results The maximum diameter of expansion of the EPSs in the vertebral body was 7.63 mm, a 17.38% increase from the original diameter. The maximum diameter of the EPS trajectory and the diameter of the EPS trajectory in the pedicle were 7.56 mm and 7.09 mm, respectively, increases of 16.31% and 9.08%. The differences were statistically significant (P<0.05). In the pedicle, there was a negative correlation between the diameter of the EPS trajectory and the BV/TV along the EPS trajectory (r=−0.88; P=0.002). In the vertebral body, a negative correlation occurred between the maximum expansion diameter of the EPS and vertebral BV/TV (r=−0.85; P=0.004). Conclusions The EPS could be reliably removed after expansion without fracturing the pedicle. Furthermore, the BV/TV had an important influence on the degree of expansion of EPS and whether or not pedicle fracture occurs.

Stress Distribution on the Screws in Posterior Lumbar Fusion of Isthmic Spondylolisthesis with 2- or 3-Vertebra Fixation Techniques: A Biomechanical Cadaveric Study

BACKGROUND Two- or three-vertebra fixation techniques are both used in the treatment of spondylolisthesis. However, the number of spinal segments that should be implanted in spondylolisthesis reduction and fixation is still controversial, and there are no published reports on stress distribution on the screws with 2- or 3-vertebra fixation techniques. Understanding stress distribution in screws would be of potential great clinical importance and supply more biomechanical evidence in surgery. The aim of this study was to compare and quantitatively analyze the stress distribution on the screws in 2- or 3-vertebra fixation techniques in cadaveric models of spondylolisthesis. MATERIALS AND METHODS Sixteen fresh specimens of human lumbar spines were used in this study. The spondylolisthesis model was generated by Panjabi method and fixed with the SINO universal spine system by 2- (group A) or 3-vertebra (group B) fixation technique. Rectangular electrical resistance strain gauges were fixed at upper and lower surface of the root of screws bilaterally. The samples were tested under flexion/extension, left/right lateral bending, and axial compression loading. Stress on the screws was measured by strain gauge monitor, respectively. RESULTS Under the five different loading conditions, the stress could be compressive stress or tensile stress. Under the compression, flexion, and bending loading condition, the stress in reduction screws in group A is higher than in group B (P < 0.01). However, under the extension loading condition, stress of lower surface in reduction screws in group A is 49% lower than in group B. With regard to the anchor screws, under flexion and lateral bending conditions, stress in group A is lower than in group B (P < 0.05). Under compression and extension loading conditions, stress in group A is slightly higher than in group B, but no significant difference is detected. CONCLUSIONS In most loading conditions, stress in reduction screws in 2-vertebra fixation technique was higher than in 3-vertebra fixation technique. The 3-vertebra fixation technique might effectively reduce stress on the reduction screws, and decrease the probability of fatigue fractures of the screws.