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This is a retrospective clinical study (chart review) of patients who have previously undergone TLIF or PLIF surgery with the FlareHawk expandable interbody fusion cage at one or two contiguous levels.
The purpose of this study is to evaluate the clinical outcomes of patients who have undergone a TLIF or PLIF procedure with a FlareHawk expandable interbody fusion cage(s) to assess the device's performance and safety when used in accordance with its intended use. The primary hypothesis is that study subjects who received the FlareHawk expandable cage(s) through a TLIF or PLIF procedure experienced fusion by 12 months (+/- 3 mo) follow-up, with improvements in clinical outcomes related to pain and/or disability compared to pre-operative scores. Further, the subjects are hypothesized to have not experienced any unforeseen device- or procedure-related adverse events.
Degenerative Disc Disease
FlareHawk Interbody Fusion System
Not yet recruiting
Integrity Implants Inc.
Published on BioPortfolio: 2019-08-18T20:09:27-0400
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 evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in patients with spondylolisthesis (≥ grade I). ...
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.
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The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disea...
The effects of oblique lateral interbody fusion (OLIF) and minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) have not been compared by a meta-analysis. The present study aimed to sum...
In an aging society, the number of patients with symptomatic degenerative spondylolisthesis (DS) is increasing and there is an emerging need for fusion surgery. However, few studies have compared tran...
Standard treatment protocols for lumbar degenerative lesions in the setting of rheumatoid arthritis (RA) are lacking. The purpose of this study was to evaluate the clinical and radiologic outcomes ...
To compare the impact of minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) with open posterior lumbar interbody fusion (PLIF) on sagittal lumbar-pelvic radiographic parameters for d...
The main purpose of this study was to design, manufacture and implant a customized three-dimensional (3D) printed, intervertebral spacer to treat disc-associated cervical spondylomyelopathy (DACSM)...
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.
A degenerative disease of the AUTONOMIC NERVOUS SYSTEM that is characterized by idiopathic ORTHOSTATIC HYPOTENSION and a greatly reduced level of CATECHOLAMINES. No other neurological deficits are present.
An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...