1.Radiologic and Clinical Outcomes of Surgery in High Grade Spondylolisthesis Treated with Temporary Distraction Rod.
Farzad OMIDI-KASHANI ; Alireza HOOTKANI ; Lida JARAHI ; Manizheh REZVAN ; Amir MOAYEDPOUR
Clinics in Orthopedic Surgery 2015;7(1):85-90
		                        		
		                        			
		                        			BACKGROUND: Surgical techniques used in the treatment of patients with high grade lumbar spondylolisthesis (> 50% slippage) are usually associated with a great deal of controversies. We aim to evaluate the surgical outcomes of high grade spondylolisthesis treated with an intraoperative temporary distraction rod. METHODS: We retrospectively studied 21 patients (14 females and 7 males), aged 50.4 +/- 9.2 years, who had high grade lumbar spondylolisthesis that was treated with intraoperative temporary distraction rods, neural decompression, pedicular screw fixation, and posterolateral fusion involving one more intact upper vertebra. The mean follow-up period was 39.2 months. Radiologic and clinical outcomes were measured by slip angle, slip percentage, correction rate, Oswestry Disability Index (ODI), visual analogue scale (VAS), patient's satisfaction rate in the pre- and postoperative period. Data were analyzed by SPSS ver. 11.5. RESULTS: Analysis of the preoperative visits and final follow-up visits indicated that surgery could improve ODI, lumbar VAS, and leg VAS from 60.5% to 8.2%, from 6.7 to 2.2, and from 6.9 to 1.3, respectively. Slip angle and slip percentage were also changed from -8degrees to -15degrees and from 59.2% to 21.4%, respectively. Mean correction rate at the final follow-up visit was 64.1%. Loss of correction was insignificant and a neurologic complication occurred in one patient due to misplacement of one screw. Excellent and good levels of satisfaction were observed in 90.5% of the patients. CONCLUSIONS: In the surgical treatment of refractory high grade spondylolisthesis, the use of a temporary distraction rod to reduce the slipped vertebra in combination with neural decompression, posterolateral fusion, and longer instrumentation is associated with satisfactory clinical and radiologic outcomes.
		                        		
		                        		
		                        		
		                        			Adult
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		                        			Bone Nails
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		                        			Decompression, Surgical
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		                        			Female
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		                        			Humans
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		                        			Lumbar Vertebrae/*surgery
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		                        			Male
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		                        			Middle Aged
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		                        			Retrospective Studies
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		                        			Spinal Fusion/instrumentation/*methods
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		                        			Spondylolisthesis/*surgery
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		                        			Treatment Outcome
		                        			
		                        		
		                        	
2.Single-level Anterior Corpectomy with Fusion versus 2-level Anterior Cervical Decompression with Fusion: A Prospective Controlled Study with 2-year Follow-up Using Cages for Fusion.
Hwee Weng HEY ; Keng Lin WONG ; Ai Sha LONG ; Hwan Tak HEE
Annals of the Academy of Medicine, Singapore 2015;44(5):188-190
3.Change of Regulatory Requirement on Cohort Grouping and Endpoint Seting for Intervertebral Fusion Device Clinical Trial.
Chinese Journal of Medical Instrumentation 2015;39(4):279-281
		                        		
		                        			
		                        			Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rationally lessen industrial burdensome.
		                        		
		                        		
		                        		
		                        			China
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		                        			Clinical Trials as Topic
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		                        			standards
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		                        			Cohort Studies
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		                        			Endpoint Determination
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		                        			Humans
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		                        			Research Design
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		                        			standards
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		                        			Spinal Fusion
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		                        			instrumentation
		                        			
		                        		
		                        	
4.Clinical application of stand-alone MC+PEEK cage in the anterior cervical fusion.
Bing JIANG ; Yan-Qing CAO ; Hong PAN ; Cheng-Run ZHU ; Xiao-Jun ZHANG ; Yue-Feng TAO ; Zhen LIU
China Journal of Orthopaedics and Traumatology 2015;28(4):294-299
OBJECTIVETo explore the effect of clinical application of stand-alone MC+PEEK cage in anterior cervical fusion.
METHODSFrom January 2011 to January 2014,50 patients were treated with the MC+PEEK cage filled with autogenous cancellous illic-bone graft after anterior cervical discectomy. There were 22 patients with cervical spondylosis,26 patients with traumatic cervical disc herniation, 2 patients with cervical instability in these patients. There were 32 males and 18 females, aged from 30 to 79 years old with an average of 53.30 years old. There were 32 patients with single segment, 15 patients with double segments and 3 patients with three segments. Cervical AP and lateral and the flexion-extension X-rays were regularly taken in order to assess the cervical physiological curvature, the graft fusion and internal fixation related complications. Nerve function, clinical effect and bone fusion were respectively evaluated according to Japan Orthopedic Association (JOA), Otani grade and Suk method.
RESULTSAll patients were followed up from 6 to 36 months with an average of 20 months. No correlated surgical complications were found and all patients obtained bony fusion with an average time of 4.30 months. JOA score had significantly improvement after surgery (P < 0.05). The JOA score was 10.60 ± 3.00 before surgery and 16.10 ± 2.20, 16.40 ± 2.35 at one week and six months after surgery respectively. According to Otani grade,40 cases got excellent results, 9 good, 1 fair. No significant dysphagia and internal fixation related complications such as displacement of cages were found during the follow-up period.
CONCLUSIONUsing this cage in anterior cervical fusion can obtain satisfactory clinical effect with less operation injury and reduce the complications. It is a better fusion method in anterior cervical fusion.
Adult ; Aged ; Cervical Vertebrae ; surgery ; Female ; Humans ; Male ; Middle Aged ; Spinal Fusion ; adverse effects ; instrumentation ; methods
6.The clinical value of end plate rings in preventing subsidence of titanium cage in anterior cervical corpectomy and fusion surgery.
Lei HE ; Yu QIAN ; Yi-Jun JIN ; Liang FAN ; Zuo LÜ
China Journal of Orthopaedics and Traumatology 2014;27(9):738-744
OBJECTIVETo evaluate the clinical results of using end plate rings in preventing subsidence of titanium cage in anterior cervical corpectomy and fusion (ACCF) surgery.
METHODSThe clinical data of 71 patients with cervical spondylotic myelopathy underwent ACCF in single segment from February 2008 to February 2011 were retrospectively analyzed. There were 38 males and 33 females, aged from 39 to 74 years old with a mean of 53.8 years. Thirty-three were used end plate rings and thirty-eight were not used (end plate rings group and no end plate ring group, respectively). The Japanese Orthopaedic Association (JOA) score, Odom's scale, imaging data were used to evaluate the clinical effects. Imaging data including Cobb angle of fusion segment, intervertebral height of anterior border (Da) and posterior border (Dp), the mean intervertebral height (Dm).
RESULTSAll patients were followed up from 13 to 34 months with an average of 19.5 months. Between two groups, there was no significant difference in Cobb angle of fusion segment and the mean intervertebral height (Dm) before surgery and one week after surgery. Whereas, one year after surgery, the Cobb angle of end plate ring group was (9.4 ± 3.8) degrees, and contral group was (7.5 ± 3.9) degrees, which was significantly lower than that of end plate ring group. Meanwhile, the Dm of end plate ring group was (57.3 ± 2.2) mm, and no end ring group was (55.2 ± 2.6) mm which was significantly lower than that of end plate ring group. The subsidence in end plate ring group was 57.6%, and was 78.9% in no end plate ring group. There was no significant difference in JOA score before and after surgery between two groups. At 1 year after operation, 90.9% (30/33) got excellent or good results in end plate ring group, 89.5% (33/38) got excellent or good results in contral group.
CONCLUSIONThe use of end plate rings could not completely prevent the subsidence of titanium cage, however, which can decrease the occurrence rate of the subsidence and lessen its degree.
Adult ; Aged ; Bone Plates ; Cervical Vertebrae ; pathology ; surgery ; Female ; Humans ; Male ; Middle Aged ; Orthopedic Fixation Devices ; adverse effects ; Spinal Fusion ; instrumentation ; methods ; Spondylosis ; pathology ; surgery ; Titanium
7.Radiological study on the n-HA/PA66 cage used in the transforaminal lumbar interbody fusion.
Pei-ming SANG ; Ming ZHANG ; Bin-hui CHEN ; Chang CAI ; Shi-rong GU ; Min ZHOU
China Journal of Orthopaedics and Traumatology 2014;27(8):654-657
OBJECTIVETo explore the effects of nano-hydroxyapatite/polyamide 66 (n-HA/PA66) cage on recovering and maintaining lumbar curvature, lumbar heights and fusion rate when used in the transforaminal lumbar interbody fusion.
METHODSFrom February to July 2012, 50 patients with degenerative lumbar disease(lumbar disc herniation in 32 cases and lumbar spondylolisthesis in 18 cases) were treated with transforaminal lumbar interbody fusion using the n-HA/PA66 cage, and their preoperative and postoperative clinical outcomes were analyzed. The patients were followed up for 2, 4, 6 and 8 months after operation, during which the CR and CT film of lumbar vertebra were checked to get relative height of vertebral space, Taillard index,index of lumbar spinal curvature,angle of segmental and full lumbar lordosis. The data were analyzed respectively with pair t-test, analysis of variance or LSD-t-test.
RESULTSAll the patients were followed up, and the duraion ranged from 8 to 13 months, with a mean of 11.32 months. There were significant differences in relative height of vertebral space, Taillard index, index of lumbar spinal curvature, angle of segmental and full lumbar lordosis after surgery, but there were no significant differences in different periods after operation. The fusion time of lumbar ranged from 4 to 8 months.
CONCLUSIONThe n-HA/PA66 cage can recover and maintain lumbar normal stability with higher rate of fusion and less complications.
Adult ; Durapatite ; administration & dosage ; Female ; Humans ; Intervertebral Disc Displacement ; surgery ; Lumbar Vertebrae ; surgery ; Male ; Middle Aged ; Nylons ; Spinal Fusion ; adverse effects ; instrumentation ; methods ; Spondylolisthesis ; surgery ; Tomography, X-Ray Computed
8.Comparison of ROI-C and traditional cage with anterior plating for anterior cervical discectomy and fusion.
Zhiwen WANG ; Weimin JIANG ; Zongyu ZHANG ; Heng WANG ; Xuefeng LI ; Jinhui SHI ; Jie CHEN ; Huilin YANG
Chinese Journal of Surgery 2014;52(6):425-430
OBJECTIVETo study clinical outcomes following anterior cervical discectomy and fusion (ACDF) using ROI-C compared to traditional cage with anterior plating in treating the cervical spondylotic myelopathy.
METHODSA total of 66 patients with the cervical spondylotic myelopathy were treated with ACDF between April 2011 and October 2012. Twenty-three patients underwent ACDF using the ROI-C device were classified as the ROI-C group and 43 patients received traditional cage with anterior plating served as the titanium plate group. Related indicators, such as operation time, intraoperative blood loss, intraoperative fluoroscopy times, incidence of postoperative dysphagia and ratio of bone graft fusion were recorded and compared between two groups. The clinical outcomes were evaluated by Japanese Orthopaedic Association (JOA) scores and visual analog scale (VAS) scores. The pre- and postoperative results were compared with a paired sample t-test. The results between groups were compared utilizing the grouped t-test or χ² test.
RESULTSAll cases were followed up. The follow-up period was 12 to 38 months and 14 to 39 months in ROI-C group and titanium plate group respectively. For the age, gender, the JOA scores, VAS scores of neck pain and arm pain during preoperative, the surgical level constituent ratio and the follow-up time, there were no significant differences between two groups. In ROI-C group, the operation time was (123 ± 38) minutes, intraoperative blood loss was (84 ± 37)ml, exposure times to the X-ray C-arm machine was (3.5 ± 0.7) times, which were all significantly lower than titanium plate group ((165 ± 60) minutes, (128 ± 66) ml, (5.9 ± 1.2) times respectively, t = -3.27, -3.25, - 9.45, P = 0.02, 0.02, 0.00). The mean JOA scores increased significantly from pre-surgery to 1 month postoperatively, 3 months postoperatively, and last follow-up in ROI-C group (t = 11.94, 11.32, 10.60, all P = 0.00) and titanium plate group(t = 15.07, 19.51, 17.55, all P = 0.00). The mean VAS scores of neck pain and arm pain decreased significantly from pre-surgery to 1 month postoperatively, 3 months postoperatively, and last follow-up in ROI-C group (t = -16.64-- 9.68, all P = 0.00) and titanium group(t = -16.56--12.38, all P = 0.00). There was no significant difference on JOA scores and VAS scores of neck pain and arm pain between the two groups at the same time (P > 0.05). However, significant difference was observed in incidence of postoperative dysphagia (χ² = 6.79, P = 0.01). In addition, bony fusion was obtained in all cases at the last follow-up postoperatively. There was no significant difference on ratio of bone graft fusion between two groups.
CONCLUSIONThe ROI-C leads to similar clinical outcomes compared to traditional cage combined with anterior plating for the treatment of the cervical spondylotic myelopathy, while the ROI-C carries a simpler operation, shorter operation time, less intraoperative blood loss, less exposure times to the X-ray and a lower risk of postoperative dysphagia.
Adult ; Aged ; Bone Plates ; Cervical Vertebrae ; surgery ; Diskectomy ; methods ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Spinal Fusion ; instrumentation ; methods ; Titanium ; Treatment Outcome
9.Effectiveness of nano-hydroxyapatite/polyamide 66 cage in anterior spinal reconstruction: a mid-term study.
Xi YANG ; Yueming SONG ; Limin LIU ; Qingquan KONG ; Quan GONG ; Jiancheng ZENG ; Tao LI ; Chongqi TU
Chinese Journal of Surgery 2014;52(1):20-24
OBJECTIVETo evaluate the mid-term effectiveness of nano-hydroxyapatite/polyamide66 (n-HA/PA66) cage in the anterior spinal reconstruction.
METHODSThere were 177 patients who undergone the anterior decompression and fusion with n-HA/PA66 cage and internal fixation between January 2008 and January 2010 included in this study. There were 117 male and 60 female patients aged from 18 to 74 years. The diagnoses included cervical fracture in 47 patients, thoracic or lumbar fracture in 50 patients, cervical spondylopathy in 58 patients, spinal tuberculosis in 17 patients and spinal tumor in 5 patients. The X-ray and three-dimensional CT were followed up in all these patients to observe the spinal alignment, the rate of fusion and the rate of n-HA/PA66 cage subsidence and translocation. The neurological functions of patients with spinal fracture were evaluated by Frankel grading; the improvement of the clinical symptoms of the other patients were assessed by visual analogue scale (VAS) scores and Japan Orthopaedic Association (JOA) scores or SF-36 scores.
RESULTSAll the 177 patients had been followed-up for 36 to 70 months after surgery (average 51 months). Except the slight cage translocation been found in the only one patient with cervical fracture, no cage prolapsed or breakage was exist in our patients up to the last follow-up. In the patients with spinal fracture, the mean time for fusion was 4.5 months, the rate of fusion was 95.9% and the rate of cage subsidence was 5.2%; while in the patients with cervical spondylopathy, the mean time for fusion was 4.4 months, the fusion rate was 96.5% and the subsidence rate was 5.2%; while in patients with spinal tuberculosis, the mean fusion time was 5.5 months, the rate of fusion was 94.0%, the rate of subsidence was 5.9%; and in the patients with tumor, the mean time for fusion was 6.0 months, the fusion rate was 100%, and the cage subsidence was found in only one patient. The preoperative symptoms of each patient were improved to varying degrees after surgery. At the last follow-up, the Frankel grading of patients of spinal fracture with incomplete paralysis improved 0 to 2 classes; the VAS, JOA or SF-36 scores of the other patients were improved significantly than their respective scores before surgery (t = 2.982, 4.126 and 3.980, P < 0.05).
CONCLUSIONSThe n-HA/PA66 cage has much higher rate of osseous fusion and lower cage subsidence, it is an ideal cage which can provide effective restoring and maintaining for the spinal alignment and intervertebral height. Moreover, the mid-term clinical results of anterior reconstruction with this cage in the patients with spinal trauma, degeneration, tuberculosis or tumor are well content.
Adolescent ; Adult ; Aged ; Durapatite ; Female ; Fracture Fixation, Internal ; instrumentation ; Humans ; Male ; Middle Aged ; Nanostructures ; Nylons ; Spinal Diseases ; surgery ; Spinal Fusion ; instrumentation ; methods ; Treatment Outcome ; Young Adult
10.Preliminary clinical results of endoscopic assisted anterior lumbar interbody fusion.
Qing-chu LI ; Ze-zheng LIU ; Hui-bo YAN ; Da-di JIN
Chinese Journal of Surgery 2013;51(11):1005-1009
OBJECTIVETo summarize the experiences of endoscopic assisted anterior lumbar interbody fusion (ALIF) with self-locking cage via retroperitoneal approach through small incision lateral to abdominal rectus.
METHODSThere were 47 cases of endoscopic assisted ALIF from April 2010 to April 2012 were reviewed retrospectively, including 28 male and 19 female patients whose age ranged from 39 to 65 years, averaged of (48 ± 11) years. Of 47 cases, 17 cases were founded instability in lumbar spine, 16 cases of discogenetic low back pain, 7 cases of degenerative spondylolithesis, and 7 cases of recurrent disc herniation. The level involved included 7 cases at L3-4 level, 33 cases at L4-5 level, 7 cases at L5-S1. X-ray and/or 3D CT scan were done in each patient at post-operative day 4, 1 month, 3 months, and 6 months. The height and angle of disc space, angle of lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT), and sacral slope (SS) were recorded and measured, as well as length of incision, operation time, blood loss, complications and ratio of bone graft fusion. The clinical outcomes were evaluated by Oswestry disability index (ODI) and visual analogue scale (VAS).
RESULTSAverage length of incision was (6.2 ± 0.8)cm (5.3-7.8 cm) , average blood loss was (81 ± 20)ml (50-150 ml) , mean operation time was (96 ± 10)minutes (65-122 minutes) . There were significant improvement of ODI(48% ± 10% vs. 14% ± 5%), the VAS of back pain(6.3 ± 1.1 vs.0.7 ± 0.7) and VAS of leg pain(3.4 ± 2.1 vs.0.6 ± 0.6) during preoperative and postoperation last follow-up (t = 20.78, 25.92 and 8.74, P = 0.000). The disc height of operative segments were all recovered significantly (F = 18.971, P = 0.000) postoperatively, from preoperative (10.3 ± 2.4)mm to postoperative (12.6 ± 2.1)mm. For complications, 5 cases had peritoneum tear, 19 cases had bone donor site pain, 14 cases had abdominal distension and 5 cases had lower limb paraesthesia, which were all treated with supportive managements. Bony intervertebral fusion was obtained in all cases in 6 months postoperatively.
CONCLUSIONSThe advantages of endoscopic assisted ALIF with self-locking cage via retroperitoneal approach are less damage, rapid recovery, and less blood loss. Comparing with traditional ALIF procedure, the view of operative field is also improved.
Adult ; Aged ; Endoscopy ; Female ; Humans ; Internal Fixators ; Lumbar Vertebrae ; surgery ; Male ; Middle Aged ; Retrospective Studies ; Spinal Fusion ; instrumentation
            
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