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Seba Ramhmdani, Marc Comair, Camilo A Molina, Daniel M Sciubba, Ali Bydon
Interspinous process devices (IPDs) have been developed as less-invasive alternatives to spinal fusion with the goal of decompressing the spinal canal and preserving segmental motion. IPD implantation is proposed to treat symptoms of lumbar spinal stenosis that improve during flexion. Recent indications of IPD include lumbar facet joint syndrome, which is seen in patients with mainly low-back pain. Long-term outcomes in this subset of patients are largely unknown. The authors present a previously unreported complication of coflex (IPD) placement: the development of a large compressive lumbar synovial cyst...
June 15, 2018: Journal of Neurosurgery. Spine
Christopher J Kleck, Evalina L Burger
CASE: We report the development of bilateral symptomatic facet joint cysts in a 78-year-old man who had been treated with decompression and placement of a coflex device (Paradigm Spine) at L3-L4 and L4-L5. Preoperative imaging clearly demonstrated fluid in the facet joints without cysts. He underwent standard surgical treatment, but developed symptomatic facet joint cysts at 4 months postoperatively. The patient was treated with a revision decompression and replacement of the devices; there were no issues at the 32-month follow-up...
January 2018: JBJS Case Connector
Jun-Xi Zhang, Xi-Wei Jing, Ping Cui, Xin He, Ding-Jun Hao, Shu-Jing Li
The aim of the present study was to examine the curative effect of dynamic fixation Coflex treatment for patients with degenerative lumbar spinal stenosis. In the present study, 78 patients with degenerative lumbar spinal stenosis were recruited and divided equally into the control and observation groups. The control group was treated with traditional decompression fusion and the observation group received dynamic fixation Coflex system. Surgery and hospitalization were shorter in the observation group than in the control group...
January 2018: Experimental and Therapeutic Medicine
Sven Schmidt, Joerg Franke, Michael Rauschmann, Dieter Adelt, Matteo Mario Bonsanto, Steffen Sola
OBJECTIVE Surgical decompression is extremely effective in relieving pain and symptoms due to lumbar spinal stenosis (LSS). Decompression with interlaminar stabilization (D+ILS) is as effective as decompression with posterolateral fusion for stenosis, as shown in a major US FDA pivotal trial. This study reports a multicenter, randomized controlled trial in which D+ILS was compared with decompression alone (DA) for treatment of moderate to severe LSS. METHODS Under approved institutional ethics review, 230 patients (1:1 ratio) randomized to either DA or D+ILS (coflex, Paradigm Spine) were treated at 7 sites in Germany...
April 2018: Journal of Neurosurgery. Spine
Hsin-Chang Chen, Jia-Lin Wu, Shou-Chieh Huang, Zheng-Cheng Zhong, Shiu-Ling Chiu, Yu-Shu Lai, Cheng-Kung Cheng
Interspinous spacers have been designed to provide a minimally invasive surgical technique for patients with lumbar spinal stenosis or foraminal stenosis. A novel pedicle screw-based interspinous spacer has been developed in this study, and the aim of this finite element experiment was to investigate the biomechanical differences between the pedicle screw-based interspinous spacer (M-rod system) and the typical interspinous spacer (Coflex-F™). A validated finite element model of an intact lumbar spine was used to analyze the insertions of the Coflex-F™, titanium alloy M-rod (M-Ti), and polyetheretherketone M-rod (M-PEEK), independently...
August 2017: Medical Engineering & Physics
X L Chen, Y Hai, L Guan, Y Z Liu, J C Yang, Q J Su, N Kang, X L Meng, L Yang, Y Wang
Objective: To compare the mid-long term clinical effect of Topping-off surgery and lumbar fusion surgery for two-segmental lumbar degenerative disease. Methods: From March 2009 to March 2012, one hundred and twenty-six consecutive patients (Topping-off surgery and two-segment PLIF surgery) were studied in Orthopedics Department, Beijing Chao-Yang Hospital, Capital Medical University.The VAS and ODI were used to assess clinical symptoms.All patients underwent flexion/extension radiographs examinations before surgery, 1, 2 years and last follow-up postoperatively...
March 21, 2017: Zhonghua Yi Xue za Zhi [Chinese medical journal]
Raj J Gala, Glenn S Russo, Peter G Whang
PURPOSE OF REVIEW: Lumbar spinal stenosis has historically been treated with open decompressive surgery which is associated with significant morbidity and may give rise to various complications. Interspinous spacers (ISS) have been developed as a less invasive strategy which may serve to avoid many of these risks. The two current spacers that are FDA approved and commercially available are the Coflex and Superion devices. The goal is to review these two implants, their indications, and patient selection...
June 2017: Current Reviews in Musculoskeletal Medicine
Sumeet G Pawar, Arjun Dhar, Apurva Prasad, Satyashiva Munjal, P S Ramani
INTRODUCTION: Internal decompression of spinal stenosis (IDSS) and Posterior dynamic stabilization (PDS) form a bridge between decompression laminectomy alone and rigid fusion, by attempting to sustain beneficial effects of decompression and stabilization in an attempt to prevent bad effects of relentless degeneration. OBJECTIVE: To evaluate the clinical outcome in operated patient of posterior dynamic stabilization. DESIGN: Data were collected over 1 year in prospective, nonrandomized follow-up study using outcome scales...
April 2017: Neurological Research
Ai-Min Li, Xiang Li, Zhong Yang
BACKGROUND: Decompression plus spinal fusion is one of the most common surgeries for the treatment of degenerative spine disease in older adults. However, complications caused by fusion surgery have been reported in some studies. Recently published studies have reported that coflex is a safe and viable option in the selection of instrumentation for spinal stabilisation. Our meta-analysis was conducted to investigate whether decompression and coflex results in better performance for lumbar spinal stenosis (LSS) patients when compared with decompression and fusion surgery...
April 2017: International Journal of Surgery
Y Hai, X L Meng, D Y Li, X N Zhang, Y S Wang
Objective: To study the clinical results of Coflex and lumbar posterior decompression and fusion in the treatment of lumbar degenerative spondylolisthesis at L(4-5). Methods: Thirty-eight patients with Grade Ⅰ degenerative spondylolisthesis, from January 2008 to December 2011 in Beijing Chaoyang Hospital, Capital Medical University were reviewed, and patients were divided into two groups by randomness. Group A was treated with Coflex and group B with pedicle instrumentation and interbody fusion. Fifteen patients were included in group A, and 23 patients were included in group B...
March 1, 2017: Zhonghua Wai Ke za Zhi [Chinese Journal of Surgery]
Wei Yuan, Qing-Jun Su, Tie Liu, Jin-Cai Yang, Nan Kang, Li Guan, Yong Hai
Few studies have compared the clinical and radiological outcomes between Coflex interspinous stabilization and posterior lumbar interbody fusion (PLIF) for degenerative lumbar disease. We compared the at least 5-year clinical and radiological outcomes of Coflex stabilization and PLIF for lumbar degenerative disease. Eighty-seven consecutive patients with lumbar degenerative disease were retrospectively reviewed. Forty-two patients underwent decompression and Coflex interspinous stabilization (Coflex group), 45 patients underwent decompression and PLIF (PLIF group)...
January 2017: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
Hiroshi Nomura
No abstract text is available yet for this article.
June 2016: Journal of Spine Surgery (Hong Kong)
I Arrotegui
INTRODUCTION: We conducted a retrospective study in patients with disc herniation and compared the results obtained in individuals treated with the U device N6 with those acquired in patients treated without any device. The U device is a titanium alloy implant that is placed between the spinous processes. MATERIAL AND METHODS: In a cohort of 50 patients with degenerative lumbar disc, 25 underwent surgical treatment in which the U device was placed and 25 control individuals were treated with discectomy alone...
November 2015: Acta Ortopédica Mexicana
Mohsen Yaghoubi, Maziar Moradi-Lakeh, Mohammad Moradi-Joo, Vafa Rahimi-Movaghar, Neda Zamani, Ahmad Naghibzadeh-Tahami
BACKGROUND: The present study aims to evaluate the cost-effectiveness of Dynamic Interspinous Spacer (Coflex®) and Static Spacer (X-STOP ®) compared to Laminectomy (LAMI) in patients with lumbar spinal stenosis. METHODS: A decision-analysis model was developed to estimate the cost-effectiveness. The effectiveness parameters were obtained from a systematic literature review in relevant databases including PUBMED and EMBASE. A meta-analysis was performed using the STATA statistical package and a random model was used to collect measures of mean difference of visual analogue scale (VAS) pain score before and after intervention in X-stop, Coflex and LAMI (95% confidence intervals)...
2016: Medical Journal of the Islamic Republic of Iran
A X Pan, Y Hai, J C Yang, X L Chen, W Yuan, H Guo
OBJECTIVE: To assess the radiography change of lumbar spinal stenosis (LSS) treated with the implantation of Coflex interspinous device retrospectively. METHODS: Sixty patients (34 male and 26 female) with LSS who underwent the decompression and Coflex device implanted surgery from January 2010 to December 2013 were followed up. The mean age of the patients was 59.4 years. There were 33 cases underwent Coflex surgery and 27 cases underwent Topping-off surgery. The Coflex segment ranged from L1/2 to L4/5 (L1-2: 1, L2-3: 5, L3-4: 19, L4-5: 35)...
July 1, 2016: Zhonghua Wai Ke za Zhi [Chinese Journal of Surgery]
Xiao-Long Chen, Li Guan, Yu-Zeng Liu, Jin-Cai Yang, Wen-Long Wang, Yong Hai
PURPOSE: The aim of this study was to assess the outcome of symptomatic lumbar degenerative disease treated with topping-off technique (Coflex(™) combined with fusion) and compare two-segment fusion at mid-long term follow-up; and find out whether the topping-off technique can reduce the rate of adjacent segment degeneration (ASD) after fusion. METHODS: One hundred and fifty-four consecutive patients who received topping-off surgery (76 patients) and two-segment fusion surgery (88 patients) from March 2009 to March 2012 were studied...
June 2016: International Orthopaedics
Hyun W Bae, Reginald J Davis, Carl Lauryssen, Scott Leary, Greg Maislin, Michael J Musacchio
BACKGROUND: Traditional surgical options for the treatment of symptomatic lumbar spinal stenosis include decompression alone vs decompression and fusion; both options have potential limitations. OBJECTIVE: To report the 36-month follow-up analysis of the coflex Interlaminar Stabilization (Paradigm Spine, LLC, New York, New York) after decompression, examined under a Food and Drug Administration investigational device exemption clinical trial, which is intended to provide stabilization after decompression while preserving normal segmental motion at the treated level...
August 2016: Neurosurgery
Wu Che, Qian Chen, Yi-Qun Ma, Yun-Qi Jiang, Wei Yuan, Xiao-Gang Zhou, Xi-Lei Li, Jian Dong
BACKGROUND: The purpose of this biomechanical in vitro study was to compare the kinematics and intradiscal pressure achieved with 2 methods: L4-L5 pedicle screw-rod fixation (PSRF) with an upper L3-L4 Coflex device and L4-L5 PSRF alone. The results were used to characterize the biomechanics of the topping-off operation with a Coflex device for the lumbar motion segment adjacent to single-level rigid fixation. MATERIAL/METHODS: Six human cadaveric spine specimens were biomechanically tested in vitro (6 males, 0 females)...
March 29, 2016: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
Michael J Musacchio, Carl Lauryssen, Reginald J Davis, Hyun W Bae, John H Peloza, Richard D Guyer, Jack E Zigler, Donna D Ohnmeiss, Scott Leary
INTRODUCTION: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. METHODS: This prospective, randomized, controlled trial was conducted at 21 centers...
2016: International Journal of Spine Surgery
V A Byvaltsev, A A Kalinin, E G Belykh, V A Sorokovikov, V V Shepelev
UNLABELLED: Open transforaminal lumbar interbody fusion (TLIF) using transpedicular rods and interbody cage, which is used to treat segmental instability, is associated with a significant paravertebral muscle and ligament injury. A new rigid fusion method was introduced to improve the outcome of patients' treatment. OBJECTIVE: To conduct a comparative analysis of the effectiveness of minimally invasive fusion technique and TLIF to improve the treatment results in patients with symptomatic lumbar spine degeneration concomitant with moderate segmental instability of the lumbar spine...
2015: Zhurnal Voprosy Neĭrokhirurgii Imeni N. N. Burdenko
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