Annex™ Adjacent Level System for Treatment of Adjacent Level Disease
Degenerative Disc DiseaseAdjacent Level DiseaseThe purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with commercially available pedicle screw fixation systems in order to extend existing pedicle screw constructs. Subjects will be evaluated over a 2 year period and compared to historical control.
Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure
Degenerative Disc DiseaseThe primary purpose of the study is to establish the degree and duration of pain relief following minimally invasive surgery for a painful degenerative disc.
Maverick Total Disc Replacement in a 'Real World' Patient Population
Degenerative Disc DiseaseThe primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.
Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System
TraumaTumor3 moreTo prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System
Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
Degenerative Disc DiseaseSpondylolisthesis1 moreThis is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc disease (DDD) with or without radiculopathy, or spinal stenosis and/or spondylolisthesis requiring a fusion. The patient population will include adult (skeletally mature) men and women undergoing 1 or 2 level fusion in the lumbar spine (L2-S1) who are deemed eligible for the study, characterized by inclusion and exclusion criteria.
Post-Market Clinical Follow-up Study of A-SPINE's Products
Degenerative Disc DiseaseKyphosis6 moreThis is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before and after surgery.
Patient Reported Outcome After Surgical Treatment of DDD in Scandinavia
Spinal DiseasesSurgery1 morePurpose: The incidence of surgery for Degenerative lumbar Disc Disease (DDD). According to the national spine registries in Sweden, Norway and Denmark, there is a difference in surgical incidence between these countries. The cause for this difference is not known. It may reflect a difference in incidence of lumbar disc hernia, but with a similar socio-economic and ethnical background in these countries, it is more likely that the differences are due to varying surgical indications. Comparing indications for surgery, patient reported outcome and factors predictive for outcome after surgery for lumbar disc decease in these countries could provide information about optimal indications for surgery. Hypotheses: (i) there are no differences in patient-reported outcome after surgery between these countries, (ii) there are no differences in indications for surgery between these countries and (iii), factors that predict outcome are similar in these countries. Method of research: By using data from three Nordic national spine registers, investigators will compare baseline data, indications for surgery and patient reported outcome one year after surgery for lumbar disc decease. Register based studies have advantages such as large sample sizes, reflecting real life, but they also have limitations such as lower follow-up rates than clinical trials. A non-response analysis will be performed to take this into account.
Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for...
Spinal StenosisSpondylolisthesis1 moreThe purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Devices used in both systems are cleared for use and comply with US regulations and requirements.
Intra-operatory Neurophysiological Monitoring Changes as a Predictive Clinical Outcome Measure in...
Lumbar Disc DiseaseThe purpose of this study is to determine the relation among: (1) changes in voltage and amplitude of trans-operatory records obtained through the use of Intra-operative Neurophysiological Monitoring (IONM), and (2) clinical outcomes; of patients who underwent 1 or 2 levels surgical decompression at lumbar spine. IONM is the use of real time neurophysiological techniques during spinal surgeries. The modalities included in this study are: Somatosensory evoked potentials (SSEPs). Trans-cranial electric motor evoked potentials (tceMEPs). Spontaneous electromyography (EMG). Clinical outcome of the patients will be assessed through a careful evaluation of clinical data, as well as the application of three outcome scales: Oswestry Disability Index 2.1a Visual Analogue Scale for Pain Patient's Overall Impression of Change
Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion...
Intervertebral Disc DegenerationThe purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF). It is expected that this study will contribute to the compilation of clinical data required to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in patients who undergo PLIF or TLIF surgery. The results of this study will lead to further analysis (i.e. comparison to historical data of other marketed bone graft products, as well as, to local bone alone).