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This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.
As detailed by Expanding Orthopedics Inc., the FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.
The FLXfit™ is a unique titanium cage which articulates laterally as well as expands in height. This enables larger footprint support as well as restoration of disc height and lordotic angle correction. A bullet-nose design facilitates self-distraction and ease of insertion. The open architecture of the device allows it to be packed with autogenous bone graft.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Degenerative Disc Disease
FLXfit™ TLIF Interbody Fusion Device
Rush University Medical Center; Department of Orthopedic Surgery
Not yet recruiting
Rush University Medical Center
Published on BioPortfolio: 2016-06-20T18:53:21-0400
The purpose of this study is - to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in patients with spondylolisthesis (≥ grade I). ...
The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one...
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Poste...
The purpose of the study is to gather clinical and radiographic outcome data from patients who have undergone treatment with an expandable interbody spacer.
Fusion outcomes and costs of stand-alone anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF) in association with posterior fusion, and anterior/posterior (A/P) fusio...
Lumbar interbody fusion (LIF) is a treatment option for patients with degenerative disc disease (DDD). However, the effects of the most common LIF procedures-posterior LIF, transforaminal LIF, and ant...
A comparative evaluation of operative costs between single level transforaminal interbody fusion (TLIF) and standalone lateral transpsoas interbody fusion (LIF) has not yet been done.
The goal of this study was to conduct an evidence-based, quantitative assessment of the correction of lumbar lordosis achieved by each of the three principle lumbar interbody fusion techniques: anteri...
To compare the efficacy and safety of two different surgical incisions for minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) in the management of two-level degenerative lumbar disea...
Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.
The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.
Fibrocartilage inner core of the intervertebral disc. Prolapsed or bulged nucleus pulposus leads to INTERVERTEBRAL DISC DISPLACEMENT while proliferation of cells in the nucleus pulposus is associated with INTERVERTEBRAL DISC DEGENERATION.
An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...