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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.
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
Nam Lee, Dong Ah Shin, Keung Nyun Kim, Do Heum Yoon, Yoon Ha, Hyun Chul Shin, Seong Yi
OBJECTIVES: Studies have yet to investigate long-term radiologic changes in lumbar spinal stenosis patients treated with interspinous device (Coflex). This study aimed to evaluate which radiologic parameters change significantly after surgery with Coflex and identify which parameter most affects the radiologic outcome. METHODS: Of 101 patients with lumbar spinal stenosis treated by Coflex insertion on L4-5, the radiologic parameters of 30 patients were measured before and at least 2 years after surgery...
January 2016: World Neurosurgery
Seon-Heui Lee, Aram Seol, Tae-Young Cho, Soo-Young Kim, Dong-Jun Kim, Hyung-Mook Lim
BACKGROUND: A systematic literature review of interspinous dynamic stabilization, including DIAM, Wallis, Coflex, and X-STOP, was conducted to assess its safety and efficacy. METHODS: The search was done in Korean and English, by using eight domestic databases which included KoreaMed and international databases, such as Ovid Medline, Embase, and the Cochrane Library. A total of 306 articles were identified, but the animal studies, preclinical studies, and studies that reported the same results were excluded...
September 2015: Clinics in Orthopedic Surgery
Cong Xu, Fangmin Mao, Xiangyang Wang, Yan Lin, Huazi Xu
The Coflex is one of the representatives of posterior dynamic interspinous process device, but no study with the application of Coflex interlaminar stabilization in L5/S1 level has been performed. The aim of this study was to evaluate the feasibility and validity of the Coflex interlaminar stabilization in the treatment of degenerative lumbar diseases on L5/S1 level. A retrospective study was conducted for a consecutive series of 33 patients with degenerative lumbar spinal stenosis or lumbar disc herniation located in L5/S1 between November 2007 and September 2010...
November 2016: American Journal of Therapeutics
C Röder, B Baumgärtner, U Berlemann, E Aghayev
INTRODUCTION: Surgical decompression for lumbar spinal stenosis (LSS) has been associated with poorer outcomes in patients with pronounced low back pain (LBP) as compared to patients with predominant leg pain. This cross registry study assessed potential benefits of the interlaminar coflex® device as an add-on to bony decompression alone. METHODS: Patients with lumbar decompression plus coflex® (SWISSspine registry) were compared with decompressed controls (Spine Tango registry)...
October 2015: European Spine Journal
Ivan Stefanovic, Misa Radisavljevic, Dragan Stojanov
With the aim to prevent the so-called adjacent-segment disease in spinal fusion surgery and to serve as the primary surgical procedure for the management of low-back pain syndrome or neurogenic claudication in spinal stenosis, the so-called dynamic spine stabilization is applied using specifically designed implants: interspinous spacers, such as DIAM (Device for Intervertebral Assisted Motion), Coflex, and X-stop. It is commonly accepted that interspinous spacers are made from material that is well tolerated by the body, that their placement is simple, that complications are rare, and that they can greatly benefit the patients...
July 10, 2015: Journal of Neurosurgery. Spine
Xiaokang Liu, Yingjie Liu, Xiaofeng Lian, Jianguang Xu
The aim of the study was to investigate the changes of the lumbar intervertebral disc degeneration by magnetic resonance imaging (MRI) after the implantation of interspinous device and the fusion of the adjacent segment. A total of 62 consecutive patients suffering L5/S1 lumbar disc herniation (LDH) with concomitant disc space narrowing or low-grade instability up to 5 mm translational slip in L5/S1 level were treated with lumbar interbody fusion (LIF) via posterior approach. Thirty-four of these patients (Coflex group) received an additional implantation of the interspinous spacer device (Coflex™) in the level L4/L5, while the rest of 28 patients (fusion group) underwent the fusion surgery alone...
2015: International Journal of Clinical and Experimental Medicine
Hyun W Bae, Carl Lauryssen, Greg Maislin, Scott Leary, Michael J Musacchio
BACKGROUND: Approved treatment modalities for the surgical management of lumbar spinal stenosis encompass a variety of direct and indirect methods of decompression, though all have varying degrees of limitations and morbidity which potentially limit the efficacy and durability of the treatment. The coflex(®) interlaminar stabilization implant (Paradigm Spine, New York, NY), examined under a United States Food and Drug Administration (US FDA) Investigational Device Exemption (IDE) clinical trial, is shown to have durable outcomes when compared to posterolateral fusion in the setting of post-decompression stabilization for stenotic patients...
2015: International Journal of Spine Surgery
Thomas J Errico, Jonathan R Kamerlink, Martin Quirno, Jacques Samani, Robert J Chomiak
BACKGROUND: The purpose of this study was to determine the indications for implantation of the coflex device (Paradigm Spine, LLC, New York, New York), assess long-term complications, and evaluate the long-term clinical outcomes of patients. METHODS: A total of 127 patients underwent placement of a coflex implant for various indications by one orthopaedic spine surgeon. The mean follow-up was 6.3 years. The original indications for implantation were determined based upon the data provided in the case report forms...
2009: SAS Journal
Chao Kong, Shibao Lu, Yong Hai, Lei Zang
BACKGROUND: Despite numerous biomechanical studies have been carried out on dynamic stabilizers, there is very little information on their hybrid application, especially when combined interspinous dynamic stabilization with single-level fusion. The aim of this study is to assess the biomechanical effect of interspinous dynamic stabilization adjacent to single-level fusion on range of motion of the transition segment and the adjacent segment. METHODS: Six fresh lumbosacral spines (L2-S1) were tested in the following sequence: 1) intact (Construct A); 2) fusion in L5/S1 and intact in L4/5 (Construct B); 3) fusion in L5/S1 and unstable state in L4/5 (Construct C); 4) fusion in L5/S1 and Coflex in L4/5 (Construct D)...
May 2015: Clinical Biomechanics
Caryn Carr, Janice Shadwell, Pip Regan, Susan Hammett
An evaluation of a new short-stretch compression system (CoFlex UBZ, TLC and TLC Lite, Aspen Medical Europe Ltd) was undertaken in four leg ulcer clinics. A total of 19 patients aged 42-93 years were treated for up to 4 weeks, or until healed. Collated data included age, underlying diseases, leg ulcer type, ulcer duration and current treatment. The evaluation included quality of life measurements, wear time, slippage, exudate strikethrough and pain using a numerical pain score. Patients were asked to document sleep patterns...
March 2015: British Journal of Community Nursing
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