Thomas J Errico, Jonathan R Kamerlink, Martin Quirno, Jacques Samani, Robert J Chomiak
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Patients were queried about their satisfaction with the surgical procedure. Follow-up radiographs were taken to determine any device-related issues.</p><p><strong>Results: </strong>The most prevalent diagnoses for implantation were spinal stenosis (19.7%) and spinal stenosis with lumbar disc herniation (35.4%). The mean severity of low-back pain was decreased by 33% (from moderate to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from moderate to mild, P < .001). The mean severity of leg pain was decreased by 66% (from severe to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from severe to mild, P < .001). At the mean follow-up period of 6.3 years, a patient satisfaction query demonstrated that 7% were unsatisfied, 46% were satisfied, and 46% were very satisfied with their clinical outcome. Based on the follow-up radiographs, 92 of patients had no devicerelated issues and 8% had device-related issues.</p><p><strong>Conclusion: </strong>The data provided have demonstrated that the coflex implant provides pain relief for patients with low-back pain and leg pain. The most common indications for implantation were spinal stenosis and spinal stenosis with lumbar disc herniation. There were very few device-related complications.</p><p><strong>Clinical significance: </strong>Using coflex is a safe and viable option in the selection of instrumentation for spinal stabilization.</p>","PeriodicalId":88695,"journal":{"name":"SAS journal","volume":"3 2","pages":"59-67"},"PeriodicalIF":0.0000,"publicationDate":"2009-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0e/9b/SAS-3-2008-0027-RR.PMC4365593.pdf","citationCount":"23","resultStr":"{\"title\":\"Survivorship of coflex Interlaminar-Interspinous Implant.\",\"authors\":\"Thomas J Errico, Jonathan R Kamerlink, Martin Quirno, Jacques Samani, Robert J Chomiak\",\"doi\":\"10.1016/SASJ-2008-0027-RR\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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. Preoperatively and postoperatively, patients were asked to grade their low-back and leg pain using the visual analog scale (VAS) and the pain severity scale: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Patients were queried about their satisfaction with the surgical procedure. Follow-up radiographs were taken to determine any device-related issues.</p><p><strong>Results: </strong>The most prevalent diagnoses for implantation were spinal stenosis (19.7%) and spinal stenosis with lumbar disc herniation (35.4%). The mean severity of low-back pain was decreased by 33% (from moderate to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from moderate to mild, P < .001). The mean severity of leg pain was decreased by 66% (from severe to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from severe to mild, P < .001). At the mean follow-up period of 6.3 years, a patient satisfaction query demonstrated that 7% were unsatisfied, 46% were satisfied, and 46% were very satisfied with their clinical outcome. Based on the follow-up radiographs, 92 of patients had no devicerelated issues and 8% had device-related issues.</p><p><strong>Conclusion: </strong>The data provided have demonstrated that the coflex implant provides pain relief for patients with low-back pain and leg pain. The most common indications for implantation were spinal stenosis and spinal stenosis with lumbar disc herniation. 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引用次数: 23
摘要
背景:本研究的目的是确定coflex装置植入的适应症(Paradigm Spine, LLC, New York, New York)，评估长期并发症，并评估患者的长期临床结果。方法:共有127例患者接受了一个骨科脊柱外科医生的各种适应症的coflex植入。平均随访时间为6.3年。最初的植入适应症是根据病例报告表格中提供的数据确定的。术前和术后，患者被要求使用视觉模拟量表(VAS)和疼痛严重程度量表对腰背痛和腿部疼痛进行分级:无疼痛(0)、轻度疼痛(1)、中度疼痛(2)或重度疼痛(3)。询问患者对手术过程的满意度。随访x线片以确定任何与器械相关的问题。结果:椎管狭窄症(19.7%)和椎管狭窄症合并腰椎间盘突出症(35.4%)是植入术中最常见的诊断。2年随访时腰痛的平均严重程度(从中度到轻度)降低了33% (P < 0.001)， 5年随访时(从中度到轻度，P < 0.001)。在2年随访期间(从严重到轻微)和5年随访期间(从严重到轻微，P < 0.001)，腿部疼痛的平均严重程度降低了66%。在平均6.3年的随访期间，患者满意度查询显示，7%的患者不满意，46%的患者满意，46%的患者非常满意他们的临床结果。根据随访x线片，92例患者无器械相关问题，8%有器械相关问题。结论:所提供的数据表明，coflex植入物可以缓解腰痛和腿痛患者的疼痛。最常见的适应症是椎管狭窄和椎管狭窄合并腰椎间盘突出。很少有器械相关的并发症。临床意义:使用coflex固定是一种安全可行的选择。
Survivorship of coflex Interlaminar-Interspinous Implant.
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. Preoperatively and postoperatively, patients were asked to grade their low-back and leg pain using the visual analog scale (VAS) and the pain severity scale: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Patients were queried about their satisfaction with the surgical procedure. Follow-up radiographs were taken to determine any device-related issues.
Results: The most prevalent diagnoses for implantation were spinal stenosis (19.7%) and spinal stenosis with lumbar disc herniation (35.4%). The mean severity of low-back pain was decreased by 33% (from moderate to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from moderate to mild, P < .001). The mean severity of leg pain was decreased by 66% (from severe to mild) at the 2-year follow-up (P < .001) and at the 5-year follow-up (from severe to mild, P < .001). At the mean follow-up period of 6.3 years, a patient satisfaction query demonstrated that 7% were unsatisfied, 46% were satisfied, and 46% were very satisfied with their clinical outcome. Based on the follow-up radiographs, 92 of patients had no devicerelated issues and 8% had device-related issues.
Conclusion: The data provided have demonstrated that the coflex implant provides pain relief for patients with low-back pain and leg pain. The most common indications for implantation were spinal stenosis and spinal stenosis with lumbar disc herniation. There were very few device-related complications.
Clinical significance: Using coflex is a safe and viable option in the selection of instrumentation for spinal stabilization.
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