Biological performance of a bioabsorbable magnesium-magnesium phosphate cement interbody fusion cage in a porcine lumbar interbody fusion model: a feasibility study.

PURPOSE: The aim of the study was to evaluate the feasibility of a bioabsorbable cage consisting of magnesium and magnesium phosphate cement (MPC) in a porcine lumbar interbody fusion model. METHODS: Twelve male Ba-Ma mini pigs underwent lumbar discectomy and fusion with an Mg-MPC cage or a PEEK cage at the L3/L4 and L4/L5 level. Computed tomography (CT) scans were made to evaluate the distractive property by comparing average disc space height (DSH) before and at 6, 12, and 24 weeks after the operation. After the lumbar spines were harvested at 6 or 24 weeks after the operation, micro-CT examination was conducted to analyze the fusion rate, and stiffness of motion segments was investigated through mechanical tests. A histological study was performed to evaluate the tissue type, inflammation, and osteolysis in the intervertebral space. RESULTS: CT scans showed no significant difference between the two groups in average DSH at each time point. Micro-CT scans revealed an equal fusion rate in both groups (0% at 6 weeks, 83.3% at 24 weeks). Both groups showed time-dependent increases in stability, the Mg-MPC cages achieved an inferior stiffness at 6 weeks and a comparable stiffness at 24 weeks. Histologic evaluation showed the presence of newly formed bone in both groups. However, empty spaces were observed at the interface or around the Mg-MPC cages. CONCLUSION: Compared with the PEEK cages, the Mg-MPC cages achieved comparable distraction, fusion rate, and spinal stability at 24 weeks after the operation. However, due to inferior stiffness at the early stage and fast degradation, further modification of material composition and design are necessary.

Unilateral curved versus bipedicular vertebroplasty in the treatment of osteoporotic vertebral compression fractures.

BACKGROUND: Vertebral compression fracture is one of the most common complications of osteoporosis. In this study an unilateral curved vertebroplasty device was developed, and the safety, effectiveness, and surgical parameters of curved vertebroplasty (CVP) in the treatment of painful osteoporotic vertebral compression fractures was investigated and compared with traditional bipedicular vertebroplasty (BVP). METHODS: We investigated 104 vertebral augmentation procedures performed over 36 months. CVP and BVP procedures were compared for baseline clinical variables, pain relief (Visual Analog Scale, VAS), disability improvement (Oswestry Disability Index, ODI), operation time, number of fluoroscopic images, volume of cement per level, and cement leakage rate for each level treated. Complications and refracture incidence were also recorded in the two groups. RESULTS: The VAS and ODI in both group had no significant difference preoperative (P > 0.05), and a significant postoperative improvement in the VAS scores and ODI was found in both group (P < 0.001). However, the CVP group had significantly lower operation time, number of fluoroscopic images, and cement leakage rate per level than the BVP group (P < 0.05); however, the volumes of cement per level were similar in the two groups (P > 0.05). Neither group had any serious complications. Five and two patients in the BVP group developed refractures at non-adjacent and adjacent levels, respectively, with one patient developing refractures twice; however, none of the patients in the CVP group developed refractures at any level. CONCLUSIONS: Our findings revealed that both CVP and BVP were safe and effective treatments for osteoporotic vertebral compression fractures, and CVP entails a shorter operation time, less exposure to fluoroscopy, and lower rate of cement leakage.

Optimal chin-brow vertical angle for sagittal visual fields in ankylosing spondylitis kyphosis.

PURPOSE: Chin-brow vertical angle (CBVA) is very important in correction of thoracolumbar kyphotic deformity in ankylosing spondylitis (AS), especially for the patients with cervical ankylosis. In previous study, Suk et al. stated that the patients with CBVA between -10° and 10° had better horizontal gaze. Unfortunately, in our clinical practice, we found the patients with CBVA between -10° and 10° after surgery usually complained of difficulty in cooking, cleaning, desk working and the like, although they had excellent horizontal gaze. In other words, for the patients with cervical ankylosis, good horizontal gaze existed together with poor downward gaze. Then, which condition do the patients prefer? Is there a compromise solution that makes a better quality life possible for the patients? In this research, we studied AS patients with cervical ankylosis, aiming to investigate the optimal CBVA for deformity correction. METHODS: 25 AS thoracolumbar kyphotic patients with cervical ankylosis were studied, whose function and expectation of visual field related to life quality were assessed by questionnaire before and after surgery. Pre- and post-operative CBVA were obtained on lateral photos of the patients with free-standing posture, and 50 cases of CBVA were included, which were divided into six groups according to the angle irrespective of surgery (Group A, CBVA <0°; Group B, 0° ≤ CBVA < 10°; Group C, 10° ≤ CBVA < 20°; Group D, 20° ≤ CBVA < 30°; Group E, 30° ≤ CBVA < 40°; Group F, CBVA ≥ 40°). Kruskal-Wallis test was used to assess all the groups in terms of various items in the questionnaire, while Mann-Whitney test was used to assess every two groups. RESULTS: In overall evaluation, Group C (10°-20°) obtained the optimal expectation (p < 0.05); Group B, C and D (0°-30°) obtained better function (p < 0.05), and there was no significant difference between the 3 groups. In appearance, Group A, B and C (<20°) were better than the other groups both in function and expectation (p < 0.05), without dramatic difference among the three groups. In outdoor activities, Group A, B, C and D (<30°) were better in most of the items (p < 0.05). In indoor activities, Group C and D (10-30°) were much better (p < 0.05). CONCLUSION: AS thoracolumbar kyphotic patients with cervical ankylosis had the best satisfaction when 10° ≤ CBVA < 20°.

Risk Factors for New Adjacent and Remote Vertebral Fracture After Percutaneous Vertebroplasty.

OBJECTIVE: To analyze the risk factors of new adjacent vertebral fractures (AVF) and remote vertebral fractures (RVF) after percutaneous vertebroplasty (PVP) for osteoporotic vertebral compression fractures (OVCFs). METHODS: Patients who underwent additional PVP for new OVCFs were enrolled. In addition, we set a 1:1 age-, sex-, surgical segment-, and surgical date-matched control group, in which patients underwent PVP without new OVCFs. Data on body mass index, occurrence time of second PVP, vertebral computed tomography (CT) Hounsfield Unit (HU) at the fracture adjacent segment, and RVF segment were collected. RESULTS: A total of 44 patients who underwent additional PVP for new OVCFs at our hospital were included. AVF occurred significantly earlier than RVF (13.5 ± 14.1 vs. 30.4 ± 20.1 months, P = 0.007). Compared to the control group, the AVF segment CT HU was significantly lower in patients with AVF (28.7 ± 16.7 vs. 61.3 ± 14.7, P = 0.000), while there was no significant difference between patients with RVF and control group including both adjacent and RVF segment CT HU. Receiver operating characteristic curves identified a cutoff value of 43 for using adjacent segment CT HU to differentiate patients with AVF from controls, with a sensitivity of 80% and a specificity of 88.9%. CONCLUSIONS: Our study showed that the risk factors for AVF and RVF after PVP surgery were different. The occurrence of AVF was earlier and associated with low adjacent segment CT HU values, whereas the preoperative CT HU in both adjacent and RVF segments was not found to be associated with RVF.

[Clinical efficacies of skipping two-level transpedicular wedge osteotomy for correction of severe kyphosis in ankylosing spondylitis].

OBJECTIVE: To explore the clinical efficacies of skipping two-level transpedicular wedge osteotomy in the correction of severe kyphotic deformity in ankylosing spondylitis (AS). METHODS: From January 2003 to December 2009, a total of 38 consecutive patients with AS and severe kyphosis (chin-brow vertical angle (CBVA) or global thoraco-lumbar kyphosis angle (TLKA) over 70°) undergoing skipping two-level transpedicular wedge osteotomy at the Department of Orthopedics of Chinese PLA General Hospital were reviewed retrospectively. There were 32 males and 6 females with an average age of 38.0 years (range: 22 - 65). The preoperative parameters of TLKA, T11-L2 kyphotic angle, L1-S1 lordosis angle, sagittal imbalance and CBVA were obtained from the total spine radiography or computed tomography and clinical lateral photograph. According to the characteristic curves and normal spinal alignment, their profiles of osteotomy location and angle were determined and confirmed by computer simulations. Improvement in postoperative parameters was observed and treatment satisfaction evaluated RESULTS: The average operating duration was 309 minutes and the average volume of blood loss was 2050 ml. The parameters of TLKA, T11-L2 kyphotic angle and L1-S1 lordosis angle improved from 101.0° ± 21.3°, 45.2° ± 13.6°, -28.2° ± 23.3° at preoperation to 26.0° ± 12.1°, 2.8° ± 11.6°, 28.9° ± 13.3° postoperation respectively (P < 0.01). CBVA improved from 79.4° ± 15.9° to 13.6 ° ± 10.9° (P < 0.01). The sagittal imbalance distance improved from (49 ± 13) to (15 ± 7) cm (P < 0.01). All patients could walk with orthophoria and lie horizontally postoperatively. The average follow-up was 32 months (range: 24 ∼ 78 months). Fusion of osteotomy was achieved in all patients and there was no event of loss of correction or implant failure. The SRS-22 average score improved from 1.8 to 4.2. CONCLUSION: For severe kyphosis in AS, skipping two-level transpedicular wedge osteotomy is a satisfactory and reliable approach for the correction of kyphotic deformity and it may improve appearance and function significantly.

Clinical application of computer-designed polystyrene models in complex severe spinal deformities: a pilot study.

Surgical treatment of complex severe spinal deformity, involving a scoliosis Cobb angle of more than 90 degrees and kyphosis or vertebral and rib deformity, is challenging. Preoperative two-dimensional images resulting from plain film radiography, computed tomography (CT) and magnetic resonance imaging provide limited morphometric information. Although the three-dimensional (3D) reconstruction CT with special software can view the stereo and rotate the spinal image on the screen, it cannot show the full-scale spine and cannot directly be used on the operation table. This study was conducted to investigate the application of computer-designed polystyrene models in the treatment of complex severe spinal deformity. The study involved 16 cases of complex severe spinal deformity treated in our hospital between 1 May 2004 and 31 December 2007; the mean +/- SD preoperative scoliosis Cobb angle was 118 degrees +/- 27 degrees. The CT scanning digital imaging and communication in medicine (DICOM) data sets of the affected spinal segments were collected for 3D digital reconstruction and rapid prototyping to prepare computer-designed polystyrene models, which were applied in the treatment of these cases. The computer-designed polystyrene models allowed 3D observation and measurement of the deformities directly, which helped the surgeon to perform morphological assessment and communicate with the patient and colleagues. Furthermore, the models also guided the choice and placement of pedicle screws. Moreover, the models were used to aid in virtual surgery and guide the actual surgical procedure. The mean +/- SD postoperative scoliosis Cobb angle was 42 degrees +/- 32 degrees, and no serious complications such as spinal cord or major vascular injury occurred. The use of computer-designed polystyrene models could provide more accurate morphometric information and facilitate surgical correction of complex severe spinal deformity.

A novel 3D printed cage with microporous structure and in vivo fusion function.

In this study, a novel 3D printed porous titanium cage (3D printed cage) with interconnected pores inside was designed and manufactured. Observations by scanning electron microscopy showed that the inside of the 3D printed cage had an octahedral porous structure, with the pores uniform in size and connected to each other. The mechanical properties analysis found that the Young's modulus and compressive strength of the porous structure were close to those of the bone structure, and the overall stiffness was slightly higher than that of the polyether ether ketone (PEEK) material, but was significantly lower than that of the titanium alloy solid module. Animal experiments indicated that the new 3D printed cage was equivalent to PEEK cage in fusion time. At 3 months, the new bone grew into the cage through the pores of the new 3D printed cage surface, which had a high bone contact rate. These results demonstrate that the 3D printed porous titanium cage has good biocompatibility and osseointegration, and has a potential clinical value as bone implants. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part A, 2019.

A novel bacterial cellulose membrane immobilized with human umbilical cord mesenchymal stem cells-derived exosome prevents epidural fibrosis.

INTRODUCTION: Failed back surgery syndrome is a situation where there is failure after lumbar surgery aimed at correcting lumbar disease that is characterized by continuous back and/or leg pain. Epidural fibrosis and adhesions are among the major causes of failed back surgery syndrome. In recent years, several biomaterials have been applied as barriers or deterrents to prevent the compression of neural structures by postsurgical fibrosis. METHODS: In this study, a new bacterial cellulose (BC) anti-adhesion membrane, composed of exosomes from human umbilical cord mesenchymal stem cells, was developed. Its structure and morphology, water content, thickness, and mechanical properties of elasticity were analyzed and characterized. The degradation of the BC+exosomes (BC+Exos) membrane in vitro was evaluated, and its in vitro cytotoxicity and in vivo biocompatibility were tested. The prevention effect of BC+Exos membrane on epidural fibrosis post-laminectomy in a rabbit model was investigated. RESULTS: The BC+Exos membrane showed a three-dimensional network structure constituted of high-purity cellulose and moderate mechanical properties. No degeneration was observed. The BC+Exos membrane showed no cytotoxicity and displayed biocompatibility in vivo. The BC+Exos film was able to inhibit epidural fibrosis and peridural adhesions. CONCLUSION: Based on the current findings, the BC+Exos membrane is a promising material to prevent postoperative epidural fibrosis and adhesion.

[A method to avoid the fixator failure by using pedicle screw combined vertebroplasty for spine fractures].

OBJECTIVE: To study a new implant material (carbonated hydroxyapatite, CHA) united pedicle screw to cure spine fracture. METHODS: Thirty-two cases of spine compressed fracture were used with pedicle screw fixator and vertebroplasty. Before operation, patients' vertebral body were compressed (46 + 21)% (20% approximately 70%) on average. In operation, broken vertebral body was reposition through pedicle screw technique, then used self-made syringe to inject CHA into anterior and central column of broken vertebral body through pedicle. And all of patients were not given any bone-graft. RESULTS: In 6 - 26 months followed-up, no immunologic rejection was found about hydroxyapatite, and no any broken of the screws and shafts was found, no loosing and other complications either. All the patients could move in 3 - 5 days after operation. The height of the broken vertebral body were reduced 97% compared with pre-operation. And CHA in vertebral body was degraded gradually, and at the same time it was replace by new bone in vertebral body. After operation, VAS score was 61 +/- 32, and there was significant difference compared with pre-operation. CONCLUSIONS: The pedicle screw fixation united vertebroplasty is an efficient way to prevent the failure of the treatment of spine fracture.

Preparation and properties of α-calcium sulphate hemihydrate and ß-tricalcium phosphate bone substitute.

Autogenous bone graft carries the risk of complications. In contrast, artificial bone graft provides initial strength and allows new bone ingrowth. In this study, we examined methods of preparation of α-calcium sulphate hemihydrate (α-CSH) and ß-tricalcium phosphate (ß-TCP), and a composite of the two materials. Characterization of the materials was determined with X-ray diffraction, differential thermal analysis (DTA), scanning electron microscopy (SEM), and porosity analysis. ß-TCP exhibited the spatial structure and porosity of normal bone with a macropore size of 50-400 µm and some 1 µm micropores. α-CSH exhibited a regular crystal structure. A combined material was prepared in a 1:1 weight ratio, and in a rabbit model, the rate of new bone mineralization was similar to that of autogenous bone graft. The combined material of ß-TCP and α-CSH in this study may provide similar efficacy as autogenous bone graft.

Preparation of combined ß-TCP/α-CSH artificial bone graft and its performance in a spinal fusion model.

To evaluate α-calcium sulfate hemihydrate (α-CSH)/ß-tricalcium phosphate (ß-TCP) combined artificial bone graft (COB) in an animal model of posterolateral spinal fusion, α-CSH and ß-TCP were combined in a 3 : 7 weight ratio. A rabbit model of posterolateral spinal fusion was produced (N = 36); one side was implanted with the COB, and the other with local autogenous bone. Rabbits were killed on the 4th, 8th, or 12th week after surgery and fusion, COB degradation, mineralization, and new bone formation were evaluated. Scanning electron microscopy revealed that the COB retained the porous spatial structure of ß-TCP and α-CSH crystals were adhered to the surface and pores of ß-TCP. At the 12th week after surgery, the fusion rate was 75.0% on the 12th week after the operation, which was higher than the fusion rate of 54.4% the autogenous bone side (p = 0.073). Bone volume fraction of the COB was 0.49 ± 0.08 for the 4th week and 0.16 ± 0.05 for the 12th week after surgery. The mineralization rate of the new bone was greater on the side implanted with autogenous bone than on the side implanted with COB at all the three time points after surgery. At each time point after surgery, the difference in mineralization rate between the autogenous bone side and the COB side was statistically significant (p < 0.001); α-CSH/ß-TCP in a 3 : 7 weight ratio was as effective as local autogenous bone in producing spinal fusion in a rabbit model. Used in this ratio, the speed of material degradation and new bone formation are relatively equivalent, and the rate of new bone mineralization is similar to that of autogenous bone graft.

Injectable bone cement based on mineralized collagen.

A novel injectable bone cement based on mineralized collagen was reported in this paper. The cement was fabricated by introducing calcium sulfate hemihydrate (CaSO(4).1/2H(2)O, CSH) into nano-hydroxyapatite/collagen (nHAC). The workability, in vitro degradation, in vitro and in vivo biocompatibility of the cement (nHAC/CSH) were studied. The comparative tests via in vitro and in vivo showed that the nHAC/CSH composite cement processed better biocompatibiltiy than that of pure CSH cement. The results implied that this new injectable cement should be very promising for bone repair.

Investigation of the histology and interfacial bonding between carbonated hydroxyapatite cement and bone.

An ideal bone implant should facilitate the formation of a new bone layer as an osteo-integrated interface between bone and the implanted biomaterials. In the present work, the interface between carbonated hydroxyapatite (CHA) cement and bone was evaluated by interfacial bonding strength measurements and histological characterizations. CHA cement was implanted into a mongrel dog's femoral supracondylar and below the tibial plateau area, and was then tested ex vivo by, respectively, detaching and pullout experiments. Polymethylmethacrylate (PMMA) was used as a control. CHA cement could be directly injected and solidified in situ to repair bone defects. Histology results showed that CHA bonded with bone through gradual remodeling and was replaced by new bone tissue, which is an attribute for excellent biocompatibility. The interfacial bonding strength increased with implantation time. After 16 weeks implantation, the measured detaching force and the pullout force between CHA and bone were 281 +/- 16 N and 512.5 +/- 14.5 N, respectively. These values were several times higher compared to 5 days implantation. In contrast, the control showed a fibrous microstructure between PMMA and bone, and the detaching force and the pullout force decreased with implantation time. The results strongly suggest that CHA can form a better osteo-integrated interface compared to PMMA, and could be used as an ideal biomaterial for bone defect repair.

[A pilot study of repair of periodontal bone defects with carbonated phosphate bone cement modified with synthesized peptides in dogs].

OBJECTIVE: To explore the possibility of repairing periodontal defects with carbonated calcium phosphate bone cement (CCPBC) modified with synthesized peptides. METHODS: Periodontal bone defects in 4 dogs were surgically created and then restored directly with hydroxyapatite (HA), Perioglass, CCPBC and CCPBC modified with peptides. The results were compared at different levels. RESULTS: Bone replacement materials were lost in HA and Perioglass groups. In the HA group defects were restored with connective tissue. Perioglass group had only a little new bone around materials by alveolar bone. CCPBC could firmly stay in bone defects to maintain the space of bone defects even without membrane use. CCPBC modified with peptides was superior to HA, Perioglass, and CCPBC, surrounded by a great deal of new bone. CONCLUSION: Under limitation of this study, CCPBC modified with peptides has some osteoinuctive activity and may have good prospect for the clinical application in periodontal defect repair.