The present study is aimed to investigate the early clinical effects of nano-hydroxyapatite/polyamide 66 intervertebral fusion cage (n-HA/PA66 cage) for the treatment of lumbar degenerative diseases. We selected 27 patients with lumbar degenerative diseases who were managed by posterior decompression or reset operation combined with n-HA/PA66 cage intervertebral fusion and internal fixation from August 2010 to January 2012. The oswestry disability index (ODI), low back and leg pain visual analogue score (VAS), and intervertebral height (IH) were evaluated at preoperation, 1 week postoperation and the last follow-up period, respectively. Intervertebral bony fusion was evaluated at the last follow-up time. The patients were followed up for 12-24 months (averaged 19 months). The ODI, VAS and IH were significantly improved at 1 week postoperation and the last follow-up time compared with those at preoperative period (P<0.05). But there was no significant difference between 1 week postoperative and the last follow-up time (P<0.05). Brantigan's standard was used to evaluate fusion at the last follow-up time. There were 19 patients with grade 5 fusion, 8 with grade 4 fusion, with a fusion rate of 100%, and none with grade 1-3 fusions. There was no cage translocation and internal fixation breakage. These results suggested that n-HA/PA66 cage was an ideal biological material in the posterior lumbar interbody fusion and internal fixation operation for treatment of lumbar degenerative diseases. It can effectively maintain the intervertebral height and keep a high rate of bony fusion. The early clinical effect has been satisfactory.
ObjectiveTo discuss the early effectiveness of polyaminoacid/nano-hydroxyapatite/calcium sulfate (PAA/HA/CS) Cage (PHC Cage) in lumbar fusion surgery. MethodsThirty cases undergoing lumbar fusion of single segment between March and September 2014 were enrolled in this study. The patients were randomly divided into the trial group (n=20) and the control group (n=10). The PHC Cage was implanted in the trial group, while the polyetheretherketone (PEEK) Cage was implanted in the control group. The patients of 2 groups mainly presented lumbocrural pain and lower limb radiation pain or numbness. There was no significant difference in gender, age, type, affected segment, disease duration, preoperative intervertebral height, the lordosis angle of fusion segments, and the Oswestry Disability Index (ODI) between 2 groups (P > 0.05). Lateral lumbar X-ray films and three dimensional CT were taken preoperatively and at 1 week and 3, 6, and 12 months postoperatively. The intervertebral height and the lordosis angle of fusion segments at 1 week and 3, 6, and 12 months after operation and ODI at 3, 6, and 12 months after operation were measured; and the bone graft fusion rate was evaluated according to Brantigan criteria. ResultsThere was no significant difference in operation time, intraoperative blood loss, and the amount of autologous blood transfusion between 2 groups (P > 0.05). Healing by first intention was obtained in 30 cases. All patients were followed up 12 months. The intervertebral height of fusion segments, the lordosis angle of fusion segments, and ODI at each time point after operation were significantly improved when compared with preoperative ones (P < 0.05). The ODI showed significant difference between 3 months and 6, 12 months (P < 0.05), but there was no significant difference between the other time points after operation (P > 0.05). There was no significant difference in the intervertebral height and the lordosis angle of fusion segments between groups at different time points (P > 0.05). There was no significant difference in the above indexes between the trial group and the control group at each time point (P > 0.05). At last follow-up, 5 cases were rated as Brantigan grade E, 13 cases as grade D, and 2 cases as grade C in the trial group; 4 cases were rated grade E, 5 cases as grade D, and 1 case as grade C in the control group. The bone fusion rate was 90% in 2 groups. ConclusionThe PHC Cage can effectively restore and maintain the disc height of fusion segment, normal sequence and biomechanical stability of the lumbar spine. The PHC Cage is similar to the PEEK Cage and has good clinical outcome in short-term follow-up.
Objective To observe the effect of cationic liposomal ceftazidime (CLC) combined with nano-hydroxyapatite/β-tricalcium phosphate (n-HA/β-TCP) in the treatment of chronic osteomyelitis of rabbits. Methods Thirty healthy New Zealand white rabbits (4-6 months old; weighing, 2-3 kg) were selected to prepare the chronic osteomyelitis models. After 4 weeks, the gross observation, X-ray examination, and bacteriological and histopathological examinations were done; the models were made successfully in 27 rabbits. Of 27 rabbits, 24 were randomly divided into 4 groups (n=6): only debridement was performed in group A; ceftazidime was given (90 mg/kg), twice a day for 8 weeks after debridement in group B; ceftazidime and n-HA/β-TC were implanted after debridement in group C; and CLC and n-HA/β-TCP were implanted after debridement in group D. Before and after treatments, X-ray examination was done, and Norden score was recorded. At 8 weeks after treatment, the specimens were harvested for gross observation and for gross bone pathological score (GBPS) using Rissing standard; half of the specimens was used for histological observation and Smeltzer scoring, the other half for bacteriological examination and calculation of the positive rate of bacteria culture. Results At 8 weeks after treatment, Norden score of group D was significantly lower than that of groups A, B, and C (P lt; 0.05), but no significant difference was found among groups A, B, and C (P gt; 0.05). At 8 weeks after treatment, sinus healed in groups C and D, but sinus was observed in groups A and B; the GBPS scores of groups C and D were significantly lower than those of groups A and B (P lt; 0.05). The Smeltzer scores of groups C and D were significantly lower than those of groups A and B (P lt; 0.05). The positive rates of bacteria culture of groups C (0) and D (0) were significantly lower than those of group A (25.0%) and group B (16.7%) (P lt; 0.05). Conclusion CLC combined with n-HA/β-TCP has good effect in treating chronic osteomyelitis of rabbits, and it has better effect in treating chronic osteomyelitis of rabbits than ceftazidime with n-HA/β-TCP.
Objective To evaluate the security and effectiveness of nano-hydroxyapatite/polyamide 66 (n-HA/PA66) cage in reconstruction of spinal stabil ity after resection of spinal tumor. Methods Between January 2008 and December2009, 11 patients with spinal tumor underwent surgical resection and strut graft with n-HA/PA66 cage. There were 6 males and 5 females with an average age of 44.5 years (range, 16-61 years). The average disease duration was 6.8 months (range, 2-14 months). The locations of lesions included cervical spine (2 cases), thoracic spine (6 cases), and lumbar spine (3 cases). Among them, there were 5 metastatic carcinomas, 2 giant cell tumors, 1 osteoblastsarcoma, 1 chondrosarcoma, and 2 non-Hodgkin lymphoma. According to Frankel criteria for nerve function classification, there were 1 case of grade A, 3 cases of grade B, 2 cases of grade C, 2 cases of grade D, and 3 cases of grade E. Results Incisions healed by first intention in all patients, no operative or postoperative compl ication occurred. Four cases of metastatic carcinoma died of primary disease during 5-9 months after operation. Seven cases were followed up 14.4 months on average (range, 10-18 months). All patients gained significant improvement of the neurological function at 3 months after operation. All cases obtained bone fusion and good spinal stabil ity without displacement and subsidence of the n-HA/PA66 cage. The intervertebral height of the adjacent segments was (110.5 ± 16.1) mm at 3 months after operation and (109.4 ± 16.2 ) mm at the final follow-up, showing significant differenecs when compared with the preoperative height [(97.5 ± 15.4) mm, P lt; 0.05], but no significant difference between 3 months after operation and the final follow-up. In 2 patients undergoing surgery via anterior approach, bilateral pleural effusion on both sides occurred and were cured after closed thoracic drainage. During the follow-up, 2 cases (1 chondrosarcoma and 1 giant cell tumor) relapsed and underwent reoperations. Conclusion n-HA/PA66 cage can provide satisfactory bone fusion and ideal spinal stabil ity without increasing the risk of recurrence and compl ications during the surgical treatment of spinal tumors. It is an idealselection for reconstruction of spinal stability.
Objective To assess the mid-term effectiveness of anterior decompression and fusion with nano-hydroxyapatite/polyamide 66 (n-HA/PA66) cage in treatment of cervical spondylotic myelopathy. Methods A retrospective study was made on 48 patients with cervical spondylotic myelopathy who underwent anterior decompression and fusion with n-HA/PA66 cage between August 2008 and January 2010. There were 33 males and 15 females with an average age of 54.5 years (range, 42-72 years). The disease duration was 3-12 months (mean, 6 months). The affected segments included 35 cases of single segment (C3, 4 in 7, C4, 5 in 18, and C5, 6 in 10) and 13 cases of double segments (C3-5 in 7 and C4-6 in 6). Of 48 patients, 28 was diagnosed as having intervertebral disc protrusion, 12 as having ossification of posterior longitudinal ligament, and 8 as having vertebral osteophyte; 35 patients underwent single segmental anterior corpectomy and fusion, and 13 patients underwent single segmental anterior discectomy and fusion. The pre- and post-operative radiographs (cervical anteroposterior and lateral X-ray films and three-dimensional CT scans) were taken to measure the segmental height and lordosis angle. Brantigan et al assessment standard and visual analogue scale (VAS) and Japanese Orthopaedic Association (JOA) scores were used to evaluate the graft fusion and the improvement of clinical symptoms, respectively. Results All patients were followed up for 46 months on average (range, 36-54 months). No cage breaking, displacement, or sliding was found. At last follow-up, 36 cases were rated as Brantigan grade E, 10 cases as grade D, and 2 cases as grade C; the fusion rate was 96%. Both segmental height and lordosis angle were corrected significantly at immediate and 6 months after operation and last follow-up than those before operation (P lt; 0.05), but no significant difference was found among different time points after operation (P gt; 0.05). At last follow-up, the cage subsidence was (1.3 ± 1.0) mm. The VAS and JOA scores at 6 months after operation and last follow-up were significantly improved when compared with preoperative scores (P lt; 0.05), and the scores at last follow-up were superior to ones at 6 months after operation (P lt; 0.05). Conclusion The mid-term effectiveness of anterior decompression and fusion with the n-HA/PA66 cage in patients with cervical spondylotic myelopathy is satisfactory because it can effectively restore and maintain segmental height and lordosis angle and promote osseous fusion.
ObjectiveTo compare the biomechanical differences between the kidney-shaped nano-hydroxyapatite/polyamide 66 (n-HA/PA66) Cage and the bullet-shaped n-HA/PA66 Cage. MethodsL2-L5 spinal specimens were selected from 10 adult male pigs. L2, L3 and L4, L5 served as a motor unit respectively, 20 motor units altogether. They were divided into 4 groups (n=5):no treatment was given as control group (group A); nucleus pulposus resection was performed (group B); bullet-shaped Cage (group C), and kidney-shaped Cage (group D) were used in transforaminal lumbar interbody fusion (TLIF) through left intervertebral foramen and supplemented by posterior pedicle screw fixation. The intervertebral height (IH) and the position of Cages were observed on the X-ray films. The range of motion (ROM) was measured. ResultsThere was no significant difference in the preoperative IH among 4 groups (F=0.166, P=0.917). No significant change was found in IH between at pre- and post-operation in group B (P>0.05); it increased after operation in groups C and D, but difference was not statistically significant (P>0.05). There was no significant difference in the postoperative IH among groups B, C, and D (P>0.05). The distance from Cage to the left margin was (3.06±0.51) mm in group C (close to the left) and (5.68±0.69) mm in group D (close to the middle), showing significant difference (t=6.787, P=0.000). The ROM in all directions were significantly lower in groups C and D than in groups A and B (P<0.05), and in group A than in group B (P<0.05). The right bending and compression ROM of group C were significantly higher than those of group D (P<0.05), but no statistically significant difference was found in the other direction ROM (P>0.05). ConclusionThe bullet-shaped and kidney-shaped Cages have similar results in restoring IH and maintaining the stability of the spine assisted by internal fixation. Kidney-shaped Cage is more stable than bullet-shaped Cage in the axial compression and the bending load opposite implant, it can be placed in the middle and back of the vertebral body more ideally.
Objective To investigate the effect of tissue engineering bone compounded in vitro by nanohydroxyapatite/collagen/ polylactic acid (nHAC/PLA) and recombinant human bone morphogenetic protein 2 (rhBMP-2) in repairing rabbit critical calvarial defects. Methods Forty eight New Zealand rabbits, weighting 2.0-2.5 kg, were made the models of critical cranial defects(15 mm in diameter) and divided into 4 groups randomly. Defects were repaired with autoflank bone in the positive control group; with no implant in the blank control group; with nHAC/PLA in the negative control; and with active nHAC/PLA(AnHAC/PLA) in the experimental group(the average quality of each AnHAC/PLA absorbed rhBMP-2 was 1.431 mg). The reapir results were observed through X-ray,HE dyeing and Masson’s trichrism dyeing after 8 and 16 weeks. Results The difference of bone formation was observed by X-ray block degree of skull defect area at 8 and 16 weeks. In the 8 th week and 16 th week, the radiopacities on cranial defect were 67.21%±2.06% and 86.48%±1.73% in the positive control group； 5.84%±1.92% and 9.48%±2.72% in the blank control group; 19.13%±2.51% and 35.67%±3.28% in the negative control group; and 58.84%±2.55% and 8561%±3.36% in the experimental group. There were significant differences between the negative control and the positive control group, and between the experimental group and the positive control group at 8 weeks(Plt;0.05) . There were significant differences between the negative control and blank group, and between the experiment and the blank group at 8 and 16 weeks(P＜0.05). The histology observation showed that the width of bone trabecula at 16 weeks was more than that at 8 weeks and bone defectwas full of bone tissue in positive control group. The bone defect was full of fibrous tissue at 8 and 16 weeks, and there was no new bone in the blank group. The bone defect was full of remnant material and fibrous tissue in the negative control group. The implanted area was replaced by the new bone at 8 weeks and the new bone was lamellar at 16 weeks in the experimental group; the residual material was less in defect area and there were more osteoblasts surrounding. Conclusion The nHAC/PLA is a good scaffoldmaterial of rhBMP-2 and AnHAC/PLA has agood ability in repairing bone defect. So it is hopeful to be applied in the clnical repair of large bone defect.
Objective To prepare collagen-chitosan /nano-hydroxyapatite-collagen-polylactic acid (Col-CS/ nHAC-PLA) biomimetic scaffold and to examine its biocompatibility so as to lay the foundation for its application on the treatment of osteochondral defect. Methods PLA was dissolved in dioxane for getting final concentration of 8%, and the nHAC power was added at a weight ratio of nHAC to PLA, 1 ∶ 1. The solution was poured into a mold and frozen. CS and Col were dissolved in 2% acetum for getting the final concentrations of 2% and 1% respectively, then compounded at a weight ratio of CS to Col, 20 ∶ 1. The solution was poured into the frozen mold containing nHAC-PLA, and then biomimetic osteochondral scaffold of Col-CS/nHAC-PLA was prepared by freeze-drying. Acute systemic toxicity test, intracutaneous stimulation test, pyrogen test, hemolysis test, cytotoxicity test, and bone implant test were performed to evaluate its biocompatibility. Results Col-CS/nHAC-PLA had no acute systemic toxicity. Primary irritation index was 0, indicating that Col-CS/nHAC-PLA had very slight skin irritation. In pyrogen test, the increasing temperature of each rabbit was less than 0.6℃, and the increasing temperature sum of 3 rabbits was less than 1.3℃, which was consistent with the evaluation criteria. Hemolytic rate of Col-CS/nHAC-PLA was 1.38% (far less than 5%). The toxicity grade of Col-CS/nHAC-PLA was classified as grade I. Bone implant test showed that Col-CS/nHAC-PLA had good biocompatibility with the surrounding tissue. Conclusion Col-CS/ nHAC-PLA scaffold has good biocompatibility, which can be used as an alternative osteochondral scaffold.
【摘要】 目的 探讨纳米羟基磷灰石/聚酰胺66（nano-hydroxyapatite polyamide66，n-HA/PA66）颈椎融合器在颈椎间盘突出症前路手术重建中的临床疗效。 方法 2008年12月-2010年6月，对14例颈椎间盘突出症患者行前路椎间盘切除、椎管减压，以n-HA/PA66椎间融合器支撑植骨、钢板螺钉内固定治疗。随访时间3～12个月，平均6.3个月；随访时以日本矫形外科学会（Japan Orthopaedic Assoctiation， JOA）评分改善率评价患者神经功能恢复情况，复查X线片评估椎间融合器植骨融合情况，包括椎间高度及椎间融合器下沉情况。 结果 14例患者均成功完成颈椎前路减压手术以及椎间融合器的安放固定。所有患者术前症状均得到不同程度的改善，术后3、6、12个月的JOA改善率分别为87.0%、94.0%、97.0%。影像学检查显示所有患者植骨融合，椎间高度及椎间融合器的位置维持良好，无下沉、移位。 结论 n-HA/PA66颈椎间融合器具有早期支撑稳定功能，可有效维持颈椎椎间高度；术后植骨融合率高且便于X线片观察，是颈椎间盘突出症患者前路手术植骨的理想支撑材料，但长期效果需进一步随访观察。【Abstract】 Objective To evaluate the clinical effect of artificial cervical vertebra fusion apparatus of n-HA/PA66 in anterior reconstruction of cervical intervertebral disc herniation. Methods From December 2008 to June 2010, 14 patients with cervical intervertebral disc herniation underwent anterior cervical discectomy,spinal canal decompression,spinal canal decompression and reconstruction by n-HA/PA66 composite artificial vertebral body combined with plate instrumentation. The patients were followed up for 3 to 12 months with an average of 6.3 months. Neurological function was evaluated by improvement rate of JOA score and situations of the supporting body was observed by X-ray in 3,6,and 12 months after the surgery.The intervertebral height,the 1ocations, and the fusion rate of the supporting body were assessed in order to evaluate the stability of the cervical spine and alignment improvements. Results All the patients had undergone the operation successfully.The preoperative symptoms improved to varying degrees.JOA improvement rate were 87.0%, 94.0%, and 97.0% 3,6,and 12 months after the operation,respectively.Imaging studies showed that in all cases graft fusion were achieved,and cervical alignments,intervertebral height,cervical spine stability and the locations of the artificial vertebral body were well maintained.No displacement and subsidence of the artificial vertebral body occurred. Conclusion n-HA/PA66 artificial vertebral body can provide early cervical spine support and stability and cervical intervertebral height.It has a high rate of graft fusion and is convenient to observe by X-ray.Therefore,n-HA/PA66 can be taken as an ideal graft for anterior degenerative cervical spine operation,but further follow-up study is still needed to evaluate the long-term effects.
Objective To fabricate a nanohydroxyapatite-chitosan(nano-HA-CS) scaffold with high porosity by a simple and effective technique and to evaluate the physical and chemical properties and the cytocompatibility of the composite scaffold. Methods The threedimensional nano-HA-CS scaffolds with high porosity were prepared by the in situ hybridization-freeze-drying method. The microscopic morphology and components of the composite scaffolds were analyzed by the scanning electron microscopy (SEM), the transmission electron microscopy（TEM）, the X-ray diffraction（XRD）examination, and the Fourier transformed infrared spectroscopy（FTIR）. The calvarial osteoblasts were isolated from the neonatal Wistar rats. The serial subcultured cells (3rd passage) were respectively seeded onto the nanoHACS scaffold and the CS scaffold, and then were cocultured for 2, 4, 6 and 8 hours. At each time point,four specimens from each matrix were taken to determine the celladhesion rate. The cell morphology was observed by the histological staining and SEM. Results The macroporous nanoHACS scaffolds had a feature of high porosity with a pore diameter from 100 to 500 μm (mostly 400500 μm). The scaffolds had a high interval porosity; however, the interval porosity was obviously decreased and the scaffold density was increased with an increase in the contents of CS and HA. The SEM and TEM results showed that the nanosized HA was synthesized and was distributed on the pore walls homogeneously and continuously. The XRD and FTIR results showed that the HA crystals were carbonatesubstituded and not wellcrystallized. The cytocompatibility test showed that the seeded osteoblasts could adhere the scaffolds, proliferating and producing the extracellular matrix on the scaffolds. The adherence rate for the nanoHACS scaffolds was obviously higher than that for the pure CS scaffolds. Conclusion The nano-HA-CS scaffolds fabricated by the in situ hybridization-freeze-drying method have a good physical and chemical properties and a good cytocompatibility; therefore, this kind of scaffolds may be successfully used in the bone tissue engineering.